Our Blog

August 22nd, 2018

The term “liquid biopsy” is defined by the College of American Pathologists (CAP) as assays that analyze proteins, DNA, or cancer cells that circulate in the blood. There is growing interest in the less invasive, less complicated liquid biopsy as an alternative option to traditional biopsies in cases where a biopsy is not obtainable from a patient and/or a reduction in the number of biopsie...

Trends in FLT3 testing
August 7th, 2018

The FMS-like tyrosine kinase 3 gene (FLT3) marker is present in 25-30% of all AML patients and indicates a poorer prognosis.  The testing landscape is evolving and FLT3 diagnostic testing is now used in efficacy-based patient stratification, safety-based patient stratification and ongoing monitoring to assess treatment. Professor of oncology Mark Levis (John Hopkins University) an expert at t...

Spark and laboratory data
July 25th, 2018

At Diaceutics we are using a number of tools to leverage our data and to generate actionable insights.  We mine data to forecast market trends and to understand the changing biomarker landscape.  We are able to understand the use of new biomarker targets over time, review the dissemination of new companion diagnostics across the globe and build an understanding of the patient journey and rela...

Diaceutics using AI Intelligence
June 26th, 2018

Precision medicine is more impactful when we build a story through use of a complete and meaningful dataset. Many publications discuss the idea that precision medicine relies on smart technology and this is true. At Diaceutics we believe that smart technology needs to be paired with the right dataset.   For predictive algorithms in precision healthcare to work well, we need to start with what...

Diaceutics
April 20th, 2018

By Jeff Schreier, Senior Director, Marketing and Robert Feeney, Marketing Director, Global Lab Relations, Diaceutics.  A hurdle has just been cleared for patients and the laboratories who serve them. On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) that covers diagnostic laboratory tests using Next Generation Sequencin...

March 5th, 2018

Collaboration will help to organize and categorize patient testing data using artificial intelligence It is a revolutionary method which could help to identify new patient subsets The aim is to further improve the diagnosis and treatment of patients Since it was established, Diaceutics has focused on removing barriers to diagnostic test adoption and plans to use AI in its push toward democratiz...

February 28th, 2018

In a big step forward for early diagnostic use, US company Sema4 has begun offering a newborn genetic screening kit that analyses 166 genes for 193 disorders and 38 common pediatric diseases. Sema4 is a “health information company founded on the idea that more information, deeper analysis, and increased engagement will improve the diagnosis, treatment, and prevention of disease.”...

February 19th, 2018

Crohn’s disease is an inflammatory condition that affects the gastrointestinal tract and can cause symptoms including abdominal pain, diarrhoea, bleeding, joint pain, mouth sores, fatigue and weight loss. The cause is unknown but bacteria and the immune system are implicated and there is often a family connection. Factors such as genetics, stress, viruses or smoking are also linked. T...

January 9th, 2018

Alzheimer’s is a disease, very much like cancer, that affects so many of us, if not directly then through the experience of a family member or friend. There are currently 5 million people in the US living with Alzheimer’s and given that the western population experiences increasingly longer life, it’s predicted that by 2050 this figure could reach 16 million. It is thought there are 44 mi...

December 13th, 2017

A story in the UK press on 21 November 2017, Cancer tests in supermarket car parks in bid to boost detection rates, elicited the comment from Diaceutics of “Now that’s progress!” Our vision is that better testing leads to better patient outcomes and earlier diagnosis in the patient journey is a big part of that. The article also stimulated an animated discussion on public health policy. T...

December 11th, 2017

If you’re going to take part in a charity cycle race for cancer, then where better than California? This was the sunny setting for Ewelina Golebiewska and John McNamara from Diaceutics as they joined Team Pfizer in November 2017 on the two-day Padres Pedal the Cause event. “The scenery was amazing and the atmosphere even better, plus we had super supportive crowds cheering us on”, re...

December 5th, 2017

If you’ve ever had a blood test or a biopsy and questioned the time it takes to receive the results, the answer could be because the process involved can be more complex than you’d imagine, especially when a sample requires testing not once, but up to four times. Even though the range of diagnostic tests now available has increased significantly, and the analytical processes have seen immen...

November 30th, 2017

Precision or personalized medicine is taking us into an era of unprecedented breakthroughs in patient treatment and its progress depends to a great extent upon the best possible diagnostic testing. Optimizing test implementation at the laboratory level can be achieved efficiently and these improvements can directly impact and shape testing and patient outcomes. Real-time testing data suggest th...

November 17th, 2017

The ultimate aim of precision medicine is to treat a patient with a drug that perfectly fits their disease and genetic make-up. It is intended to target the disease or tumor, acting on that part of the body alone and causing minimal side effects. It’s a wonderful concept and we are beginning to see this become a reality with important advances in immuno-oncology, gene therapy and other incred...

November 13th, 2017

Think of all the rules you need to follow, and all the steps you need to take, in order to make a successful life partnership flourish. In precision medicine, where patients get diagnostic tests to establish their suitability for a specific therapy, getting the partnership right between diagnostic and pharmaceutical companies is similarly complex and challenging. However, doing it successfully ...

November 1st, 2017

During the last few years there has been intense debate about the biomarker PD-L1. It has become a significant feature of precision medicine but its uptake in diagnostic testing has been affected by a number of factors such as availability in labs, confusion over testing options, the platforms required and the interpretation and reporting of results. It’s a situation Diaceutics has been fo...

November 1st, 2017

With another FDA approval for Merck’s Keytruda, this time for gastric cancer, we see the onward march of PD-L1 therapy development. This time the therapy has been approved alongside the Agilent Technology companion diagnostic 22C3 pharmDx kit to test for PD-L1 IHC. When a therapy is approved for a new indication, pharma companies can benefit from an in-depth landscape analysi...

October 19th, 2017

The diagnostic approval process is an essential part of the commercialization and regulation of novel tests. Tests have to be approved for use by regulatory authorities and getting that approval can be a lengthy and complex process. This is made more complicated by the fact that different global regions enforce their own processes, and these regulations are constantly evolving. It is, therefore...

October 16th, 2017

Ewelina Golebiewska of Diaceutics, is swapping her lab coat for lycra in November 2017 as she takes on the uphill challenge of the Padres Pedal The Cause charity cycle race in San Diego, California. Alongside colleague John McNamara, she’ll be joining Team Pfizer to ride 156 miles over two days in the stunning California landscape. The weekend event donates 100 per cent of the money raised to...

October 12th, 2017

When it came to accepting a challenge, Shilpa Haridas, Director of Operations at Diaceutics, went for the ‘ignorance is bliss’ approach and willingly signed up for the Great North Run in September 2017. This iconic event takes place in the North East of England and is now the world’s largest half marathon. Shilpa had always enjoyed running and found it to be a calming activity but had nev...

October 12th, 2017

As precision medicine continues to promise a new future for healthcare, pharma companies need to put the teams and budgets in place to launch and commercialize their latest targeted therapies. As these therapies will likely need a companion diagnostic to identify the patients most suited to the treatment, there should also be plans in place to develop and launch the diagnostic at the same time....

September 29th, 2017

At Diaceutics, we know our support for integrated diagnostic testing by pharma companies is inextricably linked to improving patients’ access to testing and the right targeted therapy. The basic premise of precision or personalized medicine is that people are tested at the proper time in the course of their treatment pathway so that the right drug can be identified and prescribed as early as ...

September 29th, 2017

The time of the old and well-known ‘one-size-fits-all’ approach to therapy is being overtaken by precision medicine and the commercialization of multiple targeted therapies. We are now in an era in which the coexistence of diagnostics and biomarker detection on the treatment pathway is not an option, but mandatory. With regulatory authorities now favoring submission of therapy for approval ...

August 31st, 2017

Huge congratulations to Philip White, Chief Financial Officer of Diaceutics, who took part in the Prudential Ride London-Surrey 100 event in July 2017. On a beautiful day, Philip took to the streets and hills with his teammates and thousands of other cyclists, following the course set for the 2012 London Olympics. Amazingly, this was his first ever cycle race after only taking up the sport in A...

June 26th, 2017

Next Generation Sequencing (NGS), which is becoming more widely known as Comprehensive Genomic Profiling by Massively Parallel Sequencing (CGP), is set to significantly contribute to targeted therapy prescribing and complement other testing methods by 2020. Many genes are analysed simultaneously and it has the potential to detect all mutations in a patient specimen. However, the speed and sprea...

June 19th, 2017

Next Generation Sequencing (NGS), which is becoming more widely known as comprehensive genomic profiling by massively parallel sequencing (CGP), is set to significantly contribute to targeted therapy prescribing and complement other testing methods by 2020. Many genes are analysed simultaneously and it has the potential to detect all mutations in a patient specimen. However, the speed and sprea...

May 25th, 2017

Next Generation Sequencing (NGS), which is becoming more widely known as Comprehensive Genomic Profiling by Massively Parallel Sequencing (CGP), will significantly contribute to targeted therapies and precision medicine. We provide a brief snapshot of what NGS/CGP is, how it works, where it is being used, the potential difficulties and what’s on the horizon. What is Next Generation Sequencing...

May 11th, 2017

For someone who bought his first bike in April, competing in the Prudential Ride London-Surrey 100 race on July 30 2017 is certainly a challenge, but this is the attraction for Philip White, Chief Financial Officer, Diaceutics. Spurred on by the determination to raise funds for a charity very close to his heart, Philip will be following the same route taken by the world’s cycling legends at t...

May 4th, 2017

The FT US Healthcare and Life Sciences Summit in New York, now in its sixth successful year, will bring together industry leaders from across the healthcare and life sciences continuum to explore the major transformations ahead. Peter Keeling, CEO of Diaceutics, will be speaking at the May 2017 event on Leveraging diagnostics and analytics (Dx) to boost therapy return on investment – a 360° re...

April 26th, 2017

In regular Pharma Readiness reports Diaceutics analyses the global marketplace for diagnostic integration, summarizing the year that’s gone and making predictions for the months ahead. But given our unique position as thought leaders in the space, with inside knowledge of the diagnostic, pharmaceutical and laboratory industries, we have gone into more detail in the Ebook, Pharma Readiness for D...

April 18th, 2017

The US Food and Drug Administration announced on 6 April, 2017 that it has “allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to ...

April 13th, 2017

Since inception, Diaceutics has been involved in more than 200 drug launches and currently has a 60% share in the top 10 global markets. We currently count 26 out of the world’s top 30 pharmaceutical companies as clients and provide oversight, analysis and tracking of testing in 23 markets, every year helping 48,000 cancer patients access the personalized medicine that is right for them. Our ...

April 4th, 2017

The regular Pharma Readiness reports produced by Diaceutics aim to capture a snapshot of the diagnostic and precision medicine industries at certain times in a fast-evolving landscape. Pharma Readiness for Diagnostic Integration 2017 is no exception and discusses such vital topics as: Trends, best practice and preferred organizational styles in diagnostics (Dx) and precision medicine (PM) Thera...

March 21st, 2017

In the article Immuno-Oncology Drug Rivalries Highlight Biomarkers Opportunities, Challenges published in The MedTech Strategist (March 2017), the rivalries between big pharma and their biomarkers are highlighted. The battle between Merck and BMS around their Keytruda and Opdivo therapies in particular could mark “a potential turning point for the molecular diagnostics industry, which has sin...

March 13th, 2017

In an article for Clinical Lab Products magazine, The Evolution of the PD-L1 Testing Market, Peter Keeling and Ewelina Golebiewska examine how the extraordinarily dynamic PD-L1 space is providing opportunities to undertake real-time market analysis and ultimately improve our understanding of novel biomarker adoption. This active approach to real-time analysis, combined with the insights of a de...

March 13th, 2017

Implementation of biomarker testing is key to the success of precision medicine. The success of therapies based on immuno-oncology, with over six indications in recent years (predominantly lung cancer), has highlighted the need for PD-L1 biomarker testing and the challenges it raises for implementation. In our February 2017 webinar we discuss the adoption of PD-L1 testing in Europe using German...

December 20th, 2016

When a new year arrives many of us make lists about giving up this or starting that, but at Diaceutics we write a list about what we think will happen in the world of precision medicine (PM) and targeted therapies. In an ever-changing diagnostic landscape there are plenty to choose from but here are our top ten predictions.   Patient empowerment and patient centric approaches It’s easy to for...

November 25th, 2016

Those of us involved in personalized or precision medicine (PM) understand the huge impact it should have on everyone’s life and healthcare in general if all the stakeholders work for the good of the patient. This ideal represents the end of the journey but inevitably we are focussed on the practical demands of the next few stages. And the highly specialized nature of the space means we tend ...

PDL1 market blog image
November 10th, 2016

  The significant interest shown in the Diaceutics webinar How Can Analytics Help Avoid the PD-L1 Chaos: 10 Years of Insights is evidence of the widespread impact PD-L1 testing is already having on personalized medicine. Many of the issues surrounding PD-L1 that are discussed in the webinar have been seen in previous biomarker programs, but for the first time we have been able to track the clin...

November 8th, 2016

    Working out how to guide your company into the personalized medicine future can be a daunting, even overwhelming task – perhaps best to put it on hold…. But since President Obama announced to the US and the world in 2015 that personalized medicine (PM) was the way to go, it’s time to admit that this is really happening and it would be wise not to ignore it any longer. Diaceutics has bee...

October 5th, 2016

It’s easy to forget or even be unaware that laboratories are a crucial cog in personalized medicine. Obviously they run the diagnostic tests that determine which treatment will suit a patient, and they may also develop these tests, but their influence becomes clear when we recognise that they also connect with physicians at the laboratory-physician interface (LPI). The LPI is a primary and un...

September 14th, 2016

  The term competitive intelligence conjures up images of spies, undercover work and self-destructing messages. In some companies the concept may be so under the radar, or more likely underfunded, as to be almost a genuine secret, but for many pharma companies it plays a crucial role in their market research methods.   What is this intelligence and why is it needed? Hiding in a mountain of big ...

August 21st, 2016

While personalized medicine is what we at Diaceutics eat, sleep, and breathe, that’s not the case for everyone else, whether they be in pharma or just generally interested in health care, medicine and science. Luckily, we’ve got everyone covered. Now that we’re well into the second half of 2016, we’ve rounded up the top personalized medicine posts of the year so far so to keep you up to...

August 10th, 2016

Access to diagnostic tests and the subsequent reimbursement is an issue affecting all stakeholders in the fast evolving personalized medicine space. It’s an intricate web woven by drug companies, payers, insurance giants, laboratories and national health organizations. And once you think you have it sorted, you’re likely to face continuing adjustments and new considerations on pricing for e...

July 29th, 2016

Personalized medicine is becoming a part of everyone’s life. Its huge potential to change healthcare in the foreseeable future is exciting but often hard to shape given the many remaining barriers. And yet it increasingly enters our life, even if we or our loved ones are not currently receiving a personalized treatment. No week goes by without several major news stories on the topic. In just ...

July 19th, 2016

The companion diagnostic launch model is poised to become the go-to method of releasing targeted medications to the public. This approach will not only deepen public satisfaction and trust in your pharmaceutical company but also increase profit margins by targeting your research and development efforts. Here are the reasons why: 1. Simultaneous launches for companion diagnostics that are couple...

July 1st, 2016

Financial analysts have good reason to anticipate the continued growth of personalized medicine. Not only is it affecting patients and physicians but it holds plenty of promise for the pharma industry. General Strategic Development Benefits Personalized medicine encourages more vertical collaboration throughout the industry. It is therefore in the best interest of pharma companies to work more ...

June 14th, 2016

While 2015 was a record year for pharma partnerships, only a fraction of those were focused on commercialization. Competitive pressures are increasing, and pharma launches are becoming less predictable. Gain insight on partnering trends in personalized medicine and solutions for a successful partnering strategy with our new infographic. Did You Love It? Share This Infographic On Your Site <p><s...

June 10th, 2016

Companion diagnostics are diagnostic tests that provide information to guide the use of a corresponding therapy. These days, the ‘one therapy fits all’ approach to medicine has been demonstrated to be insufficient. Trial and error is often used to select a therapy for a specific person. Companion diagnostics aim to eliminate this by identifying patients who will particularly benefit from or...

June 2nd, 2016

The product launch is a moment of truth when it comes to the longevity of any pharmaceutical company. If a company manages a launch well, all of its recent shortcomings are forgiven and even patent cliffs become less scary. For the companies who will lead the way in the next century, pharmaceutical launches will look very different due to more restrictive market access and an emphasis on person...

Top Dx FInancial Planning Mistakes You Must Avoid
May 24th, 2016

When it comes to financial planning in the pharmaceutical industry there are five common mistakes that must absolutely be avoided. To understand how to remedy these mistakes, it helps to realize that one is an overarching problem in pharma financial planning, and the other four are contributing problems to this. They are: Failing to carefully vary the annual strategy and budget each year Neglec...

May 17th, 2016

For the last decade or so, much attention has been focused on personalized medicine; a modern approach that uses an individual’s genetic make-up to create a more targeted therapy or treatment. This advancement in genetics and biochemistry promises to bring to light the factors that explain why some patients largely benefit from therapy while others do not; and even in some cases go ahead to ex...

May 13th, 2016

Companion diagnostic services and personalized medicine are quickly revolutionizing the way that drugs are researched, created and marketed. To be prepared for these changes, it’s vital to understand the trends at work in the industry: Here’s what you need to know. 1. Applicability – and Demand – are Growing Quickly Personal and companion diagnostic services have seen a rapid rise in popula...

April 19th, 2016

As everyone in the industry knows, the pharmaceutical business model is far more complicated than most. It is not simply a case of developing a product, making a cost analysis, researching the competition then bringing the product to market. In pharma, the R&D phase can last 10 to 15 years from inception and a drug coming to market does not forecast its exact profit margin or future. Following ...

April 14th, 2016

The field of companion diagnostic treatments is still an emerging one and with all things new, preconceived ideas about novel therapeutic approaches and its associated technology can hinder natural acceptance and progress. In addition, a common myth concerning the launch of companion diagnostics has begun to surface. Myth: The regulatory hurdles and expense of implementing a new companion diagn...

Expert Insights

April 19th, 2018
The CMS National Coverage Decision on NGS
I. Introduction On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) that cove...
January 19th, 2018
What does the EU IVD Regulation mean for companion diagnostics and LDTs?
Dave Smart, PhD, Director at Diaceutics, discusses the introduction of the EU IVD Regulation. While it is considered a necessary step, the Regulati...

Competitive Benchmarking Reports

March 16th, 2018
PM Readiness Report 2018 Summary
March 14th, 2017
Pharma Readiness for Diagnostic Integration 2017

Publications

September 11th, 2018
BRAF mutation testing in melanoma – Poster presented at European Congress of Pathology 2018
BRAF mutation testing in melanoma: a study including Austria, Germany and UK, highlighting concordance for current technologies, and potential requirement of more sensitive technologies in future applications.
August 3rd, 2018
A Way Forward: Leveraging Advanced Diagnostic Testing to Unlock the Value of Precision Medicine
Read about how advanced diagnostic testing, ensuring that right patient gets the right therapy, at the right time, particularly with respect to therapies where the test result determines whether or not the therapy should be used (precision medicin...
August 22nd, 2018

The term “liquid biopsy” is defined by the College of American Pathologists (CAP) as assays that analyze proteins, DNA, or cancer cells that circulate in the blood. There is growing interest in the less invasive, less complicated liquid biopsy as an alternative option to traditional biopsies in cases where a biopsy is not obtainable from a patient and/or a reduction in the number of biopsie...

Trends in FLT3 testing
August 7th, 2018

The FMS-like tyrosine kinase 3 gene (FLT3) marker is present in 25-30% of all AML patients and indicates a poorer prognosis.  The testing landscape is evolving and FLT3 diagnostic testing is now used in efficacy-based patient stratification, safety-based patient stratification and ongoing monitoring to assess treatment. Professor of oncology Mark Levis (John Hopkins University) an expert at t...

Spark and laboratory data
July 25th, 2018

At Diaceutics we are using a number of tools to leverage our data and to generate actionable insights.  We mine data to forecast market trends and to understand the changing biomarker landscape.  We are able to understand the use of new biomarker targets over time, review the dissemination of new companion diagnostics across the globe and build an understanding of the patient journey and rela...

Diaceutics using AI Intelligence
June 26th, 2018

Precision medicine is more impactful when we build a story through use of a complete and meaningful dataset. Many publications discuss the idea that precision medicine relies on smart technology and this is true. At Diaceutics we believe that smart technology needs to be paired with the right dataset.   For predictive algorithms in precision healthcare to work well, we need to start with what...

Diaceutics
April 20th, 2018

By Jeff Schreier, Senior Director, Marketing and Robert Feeney, Marketing Director, Global Lab Relations, Diaceutics.  A hurdle has just been cleared for patients and the laboratories who serve them. On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) that covers diagnostic laboratory tests using Next Generation Sequencin...

March 5th, 2018

Collaboration will help to organize and categorize patient testing data using artificial intelligence It is a revolutionary method which could help to identify new patient subsets The aim is to further improve the diagnosis and treatment of patients Since it was established, Diaceutics has focused on removing barriers to diagnostic test adoption and plans to use AI in its push toward democratiz...

February 28th, 2018

In a big step forward for early diagnostic use, US company Sema4 has begun offering a newborn genetic screening kit that analyses 166 genes for 193 disorders and 38 common pediatric diseases. Sema4 is a “health information company founded on the idea that more information, deeper analysis, and increased engagement will improve the diagnosis, treatment, and prevention of disease.”...

February 19th, 2018

Crohn’s disease is an inflammatory condition that affects the gastrointestinal tract and can cause symptoms including abdominal pain, diarrhoea, bleeding, joint pain, mouth sores, fatigue and weight loss. The cause is unknown but bacteria and the immune system are implicated and there is often a family connection. Factors such as genetics, stress, viruses or smoking are also linked. T...

January 9th, 2018

Alzheimer’s is a disease, very much like cancer, that affects so many of us, if not directly then through the experience of a family member or friend. There are currently 5 million people in the US living with Alzheimer’s and given that the western population experiences increasingly longer life, it’s predicted that by 2050 this figure could reach 16 million. It is thought there are 44 mi...

December 13th, 2017

A story in the UK press on 21 November 2017, Cancer tests in supermarket car parks in bid to boost detection rates, elicited the comment from Diaceutics of “Now that’s progress!” Our vision is that better testing leads to better patient outcomes and earlier diagnosis in the patient journey is a big part of that. The article also stimulated an animated discussion on public health policy. T...

December 11th, 2017

If you’re going to take part in a charity cycle race for cancer, then where better than California? This was the sunny setting for Ewelina Golebiewska and John McNamara from Diaceutics as they joined Team Pfizer in November 2017 on the two-day Padres Pedal the Cause event. “The scenery was amazing and the atmosphere even better, plus we had super supportive crowds cheering us on”, re...

December 5th, 2017

If you’ve ever had a blood test or a biopsy and questioned the time it takes to receive the results, the answer could be because the process involved can be more complex than you’d imagine, especially when a sample requires testing not once, but up to four times. Even though the range of diagnostic tests now available has increased significantly, and the analytical processes have seen immen...

November 30th, 2017

Precision or personalized medicine is taking us into an era of unprecedented breakthroughs in patient treatment and its progress depends to a great extent upon the best possible diagnostic testing. Optimizing test implementation at the laboratory level can be achieved efficiently and these improvements can directly impact and shape testing and patient outcomes. Real-time testing data suggest th...

November 17th, 2017

The ultimate aim of precision medicine is to treat a patient with a drug that perfectly fits their disease and genetic make-up. It is intended to target the disease or tumor, acting on that part of the body alone and causing minimal side effects. It’s a wonderful concept and we are beginning to see this become a reality with important advances in immuno-oncology, gene therapy and other incred...

November 13th, 2017

Think of all the rules you need to follow, and all the steps you need to take, in order to make a successful life partnership flourish. In precision medicine, where patients get diagnostic tests to establish their suitability for a specific therapy, getting the partnership right between diagnostic and pharmaceutical companies is similarly complex and challenging. However, doing it successfully ...

November 1st, 2017

During the last few years there has been intense debate about the biomarker PD-L1. It has become a significant feature of precision medicine but its uptake in diagnostic testing has been affected by a number of factors such as availability in labs, confusion over testing options, the platforms required and the interpretation and reporting of results. It’s a situation Diaceutics has been fo...

November 1st, 2017

With another FDA approval for Merck’s Keytruda, this time for gastric cancer, we see the onward march of PD-L1 therapy development. This time the therapy has been approved alongside the Agilent Technology companion diagnostic 22C3 pharmDx kit to test for PD-L1 IHC. When a therapy is approved for a new indication, pharma companies can benefit from an in-depth landscape analysi...

October 19th, 2017

The diagnostic approval process is an essential part of the commercialization and regulation of novel tests. Tests have to be approved for use by regulatory authorities and getting that approval can be a lengthy and complex process. This is made more complicated by the fact that different global regions enforce their own processes, and these regulations are constantly evolving. It is, therefore...

October 16th, 2017

Ewelina Golebiewska of Diaceutics, is swapping her lab coat for lycra in November 2017 as she takes on the uphill challenge of the Padres Pedal The Cause charity cycle race in San Diego, California. Alongside colleague John McNamara, she’ll be joining Team Pfizer to ride 156 miles over two days in the stunning California landscape. The weekend event donates 100 per cent of the money raised to...

October 12th, 2017

When it came to accepting a challenge, Shilpa Haridas, Director of Operations at Diaceutics, went for the ‘ignorance is bliss’ approach and willingly signed up for the Great North Run in September 2017. This iconic event takes place in the North East of England and is now the world’s largest half marathon. Shilpa had always enjoyed running and found it to be a calming activity but had nev...

October 12th, 2017

As precision medicine continues to promise a new future for healthcare, pharma companies need to put the teams and budgets in place to launch and commercialize their latest targeted therapies. As these therapies will likely need a companion diagnostic to identify the patients most suited to the treatment, there should also be plans in place to develop and launch the diagnostic at the same time....

September 29th, 2017

At Diaceutics, we know our support for integrated diagnostic testing by pharma companies is inextricably linked to improving patients’ access to testing and the right targeted therapy. The basic premise of precision or personalized medicine is that people are tested at the proper time in the course of their treatment pathway so that the right drug can be identified and prescribed as early as ...

September 29th, 2017

The time of the old and well-known ‘one-size-fits-all’ approach to therapy is being overtaken by precision medicine and the commercialization of multiple targeted therapies. We are now in an era in which the coexistence of diagnostics and biomarker detection on the treatment pathway is not an option, but mandatory. With regulatory authorities now favoring submission of therapy for approval ...

August 31st, 2017

Huge congratulations to Philip White, Chief Financial Officer of Diaceutics, who took part in the Prudential Ride London-Surrey 100 event in July 2017. On a beautiful day, Philip took to the streets and hills with his teammates and thousands of other cyclists, following the course set for the 2012 London Olympics. Amazingly, this was his first ever cycle race after only taking up the sport in A...

June 26th, 2017

Next Generation Sequencing (NGS), which is becoming more widely known as Comprehensive Genomic Profiling by Massively Parallel Sequencing (CGP), is set to significantly contribute to targeted therapy prescribing and complement other testing methods by 2020. Many genes are analysed simultaneously and it has the potential to detect all mutations in a patient specimen. However, the speed and sprea...

June 19th, 2017

Next Generation Sequencing (NGS), which is becoming more widely known as comprehensive genomic profiling by massively parallel sequencing (CGP), is set to significantly contribute to targeted therapy prescribing and complement other testing methods by 2020. Many genes are analysed simultaneously and it has the potential to detect all mutations in a patient specimen. However, the speed and sprea...

May 25th, 2017

Next Generation Sequencing (NGS), which is becoming more widely known as Comprehensive Genomic Profiling by Massively Parallel Sequencing (CGP), will significantly contribute to targeted therapies and precision medicine. We provide a brief snapshot of what NGS/CGP is, how it works, where it is being used, the potential difficulties and what’s on the horizon. What is Next Generation Sequencing...

May 11th, 2017

For someone who bought his first bike in April, competing in the Prudential Ride London-Surrey 100 race on July 30 2017 is certainly a challenge, but this is the attraction for Philip White, Chief Financial Officer, Diaceutics. Spurred on by the determination to raise funds for a charity very close to his heart, Philip will be following the same route taken by the world’s cycling legends at t...

May 4th, 2017

The FT US Healthcare and Life Sciences Summit in New York, now in its sixth successful year, will bring together industry leaders from across the healthcare and life sciences continuum to explore the major transformations ahead. Peter Keeling, CEO of Diaceutics, will be speaking at the May 2017 event on Leveraging diagnostics and analytics (Dx) to boost therapy return on investment – a 360° re...

April 26th, 2017

In regular Pharma Readiness reports Diaceutics analyses the global marketplace for diagnostic integration, summarizing the year that’s gone and making predictions for the months ahead. But given our unique position as thought leaders in the space, with inside knowledge of the diagnostic, pharmaceutical and laboratory industries, we have gone into more detail in the Ebook, Pharma Readiness for D...

April 18th, 2017

The US Food and Drug Administration announced on 6 April, 2017 that it has “allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to ...

April 13th, 2017

Since inception, Diaceutics has been involved in more than 200 drug launches and currently has a 60% share in the top 10 global markets. We currently count 26 out of the world’s top 30 pharmaceutical companies as clients and provide oversight, analysis and tracking of testing in 23 markets, every year helping 48,000 cancer patients access the personalized medicine that is right for them. Our ...

April 4th, 2017

The regular Pharma Readiness reports produced by Diaceutics aim to capture a snapshot of the diagnostic and precision medicine industries at certain times in a fast-evolving landscape. Pharma Readiness for Diagnostic Integration 2017 is no exception and discusses such vital topics as: Trends, best practice and preferred organizational styles in diagnostics (Dx) and precision medicine (PM) Thera...

March 21st, 2017

In the article Immuno-Oncology Drug Rivalries Highlight Biomarkers Opportunities, Challenges published in The MedTech Strategist (March 2017), the rivalries between big pharma and their biomarkers are highlighted. The battle between Merck and BMS around their Keytruda and Opdivo therapies in particular could mark “a potential turning point for the molecular diagnostics industry, which has sin...

March 13th, 2017

In an article for Clinical Lab Products magazine, The Evolution of the PD-L1 Testing Market, Peter Keeling and Ewelina Golebiewska examine how the extraordinarily dynamic PD-L1 space is providing opportunities to undertake real-time market analysis and ultimately improve our understanding of novel biomarker adoption. This active approach to real-time analysis, combined with the insights of a de...

March 13th, 2017

Implementation of biomarker testing is key to the success of precision medicine. The success of therapies based on immuno-oncology, with over six indications in recent years (predominantly lung cancer), has highlighted the need for PD-L1 biomarker testing and the challenges it raises for implementation. In our February 2017 webinar we discuss the adoption of PD-L1 testing in Europe using German...

December 20th, 2016

When a new year arrives many of us make lists about giving up this or starting that, but at Diaceutics we write a list about what we think will happen in the world of precision medicine (PM) and targeted therapies. In an ever-changing diagnostic landscape there are plenty to choose from but here are our top ten predictions.   Patient empowerment and patient centric approaches It’s easy to for...

November 25th, 2016

Those of us involved in personalized or precision medicine (PM) understand the huge impact it should have on everyone’s life and healthcare in general if all the stakeholders work for the good of the patient. This ideal represents the end of the journey but inevitably we are focussed on the practical demands of the next few stages. And the highly specialized nature of the space means we tend ...

PDL1 market blog image
November 10th, 2016

  The significant interest shown in the Diaceutics webinar How Can Analytics Help Avoid the PD-L1 Chaos: 10 Years of Insights is evidence of the widespread impact PD-L1 testing is already having on personalized medicine. Many of the issues surrounding PD-L1 that are discussed in the webinar have been seen in previous biomarker programs, but for the first time we have been able to track the clin...

November 8th, 2016

    Working out how to guide your company into the personalized medicine future can be a daunting, even overwhelming task – perhaps best to put it on hold…. But since President Obama announced to the US and the world in 2015 that personalized medicine (PM) was the way to go, it’s time to admit that this is really happening and it would be wise not to ignore it any longer. Diaceutics has bee...

October 5th, 2016

It’s easy to forget or even be unaware that laboratories are a crucial cog in personalized medicine. Obviously they run the diagnostic tests that determine which treatment will suit a patient, and they may also develop these tests, but their influence becomes clear when we recognise that they also connect with physicians at the laboratory-physician interface (LPI). The LPI is a primary and un...

September 14th, 2016

  The term competitive intelligence conjures up images of spies, undercover work and self-destructing messages. In some companies the concept may be so under the radar, or more likely underfunded, as to be almost a genuine secret, but for many pharma companies it plays a crucial role in their market research methods.   What is this intelligence and why is it needed? Hiding in a mountain of big ...

August 21st, 2016

While personalized medicine is what we at Diaceutics eat, sleep, and breathe, that’s not the case for everyone else, whether they be in pharma or just generally interested in health care, medicine and science. Luckily, we’ve got everyone covered. Now that we’re well into the second half of 2016, we’ve rounded up the top personalized medicine posts of the year so far so to keep you up to...

August 10th, 2016

Access to diagnostic tests and the subsequent reimbursement is an issue affecting all stakeholders in the fast evolving personalized medicine space. It’s an intricate web woven by drug companies, payers, insurance giants, laboratories and national health organizations. And once you think you have it sorted, you’re likely to face continuing adjustments and new considerations on pricing for e...

July 29th, 2016

Personalized medicine is becoming a part of everyone’s life. Its huge potential to change healthcare in the foreseeable future is exciting but often hard to shape given the many remaining barriers. And yet it increasingly enters our life, even if we or our loved ones are not currently receiving a personalized treatment. No week goes by without several major news stories on the topic. In just ...

July 19th, 2016

The companion diagnostic launch model is poised to become the go-to method of releasing targeted medications to the public. This approach will not only deepen public satisfaction and trust in your pharmaceutical company but also increase profit margins by targeting your research and development efforts. Here are the reasons why: 1. Simultaneous launches for companion diagnostics that are couple...

July 1st, 2016

Financial analysts have good reason to anticipate the continued growth of personalized medicine. Not only is it affecting patients and physicians but it holds plenty of promise for the pharma industry. General Strategic Development Benefits Personalized medicine encourages more vertical collaboration throughout the industry. It is therefore in the best interest of pharma companies to work more ...

June 14th, 2016

While 2015 was a record year for pharma partnerships, only a fraction of those were focused on commercialization. Competitive pressures are increasing, and pharma launches are becoming less predictable. Gain insight on partnering trends in personalized medicine and solutions for a successful partnering strategy with our new infographic. Did You Love It? Share This Infographic On Your Site <p><s...

June 10th, 2016

Companion diagnostics are diagnostic tests that provide information to guide the use of a corresponding therapy. These days, the ‘one therapy fits all’ approach to medicine has been demonstrated to be insufficient. Trial and error is often used to select a therapy for a specific person. Companion diagnostics aim to eliminate this by identifying patients who will particularly benefit from or...

June 2nd, 2016

The product launch is a moment of truth when it comes to the longevity of any pharmaceutical company. If a company manages a launch well, all of its recent shortcomings are forgiven and even patent cliffs become less scary. For the companies who will lead the way in the next century, pharmaceutical launches will look very different due to more restrictive market access and an emphasis on person...

Top Dx FInancial Planning Mistakes You Must Avoid
May 24th, 2016

When it comes to financial planning in the pharmaceutical industry there are five common mistakes that must absolutely be avoided. To understand how to remedy these mistakes, it helps to realize that one is an overarching problem in pharma financial planning, and the other four are contributing problems to this. They are: Failing to carefully vary the annual strategy and budget each year Neglec...

May 17th, 2016

For the last decade or so, much attention has been focused on personalized medicine; a modern approach that uses an individual’s genetic make-up to create a more targeted therapy or treatment. This advancement in genetics and biochemistry promises to bring to light the factors that explain why some patients largely benefit from therapy while others do not; and even in some cases go ahead to ex...

May 13th, 2016

Companion diagnostic services and personalized medicine are quickly revolutionizing the way that drugs are researched, created and marketed. To be prepared for these changes, it’s vital to understand the trends at work in the industry: Here’s what you need to know. 1. Applicability – and Demand – are Growing Quickly Personal and companion diagnostic services have seen a rapid rise in popula...

April 19th, 2016

As everyone in the industry knows, the pharmaceutical business model is far more complicated than most. It is not simply a case of developing a product, making a cost analysis, researching the competition then bringing the product to market. In pharma, the R&D phase can last 10 to 15 years from inception and a drug coming to market does not forecast its exact profit margin or future. Following ...

April 14th, 2016

The field of companion diagnostic treatments is still an emerging one and with all things new, preconceived ideas about novel therapeutic approaches and its associated technology can hinder natural acceptance and progress. In addition, a common myth concerning the launch of companion diagnostics has begun to surface. Myth: The regulatory hurdles and expense of implementing a new companion diagn...

August 23rd, 2018

The FDA intends to make the development and review of cancer drugs more efficient under the Real Time Oncology Review (RTOR) pilot program. Under this supplemental applications pilot, launched last year, evaluation of clinical data begins as soon as clinical data becomes available and results are ‘locked’. This means that the FDA is in a position to approve a formal application much sooner....

August 22nd, 2018

The term “liquid biopsy” is defined by the College of American Pathologists (CAP) as assays that analyze proteins, DNA, or cancer cells that circulate in the blood. There is growing interest in the less invasive, less complicated liquid biopsy as an alternative option to traditional biopsies in cases where a biopsy is not obtainable from a patient and/or a reduction in the number of biopsie...

Trends in FLT3 testing
August 7th, 2018

The FMS-like tyrosine kinase 3 gene (FLT3) marker is present in 25-30% of all AML patients and indicates a poorer prognosis.  The testing landscape is evolving and FLT3 diagnostic testing is now used in efficacy-based patient stratification, safety-based patient stratification and ongoing monitoring to assess treatment. Professor of oncology Mark Levis (John Hopkins University) an expert at t...

Spark and laboratory data
July 25th, 2018

At Diaceutics we are using a number of tools to leverage our data and to generate actionable insights.  We mine data to forecast market trends and to understand the changing biomarker landscape.  We are able to understand the use of new biomarker targets over time, review the dissemination of new companion diagnostics across the globe and build an understanding of the patient journey and rela...

Diaceutics using AI Intelligence
June 26th, 2018

Precision medicine is more impactful when we build a story through use of a complete and meaningful dataset. Many publications discuss the idea that precision medicine relies on smart technology and this is true. At Diaceutics we believe that smart technology needs to be paired with the right dataset.   For predictive algorithms in precision healthcare to work well, we need to start with what...

Diaceutics
April 20th, 2018

By Jeff Schreier, Senior Director, Marketing and Robert Feeney, Marketing Director, Global Lab Relations, Diaceutics.  A hurdle has just been cleared for patients and the laboratories who serve them. On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) that covers diagnostic laboratory tests using Next Generation Sequencin...

March 5th, 2018

Collaboration will help to organize and categorize patient testing data using artificial intelligence It is a revolutionary method which could help to identify new patient subsets The aim is to further improve the diagnosis and treatment of patients Since it was established, Diaceutics has focused on removing barriers to diagnostic test adoption and plans to use AI in its push toward democratiz...

February 28th, 2018

In a big step forward for early diagnostic use, US company Sema4 has begun offering a newborn genetic screening kit that analyses 166 genes for 193 disorders and 38 common pediatric diseases. Sema4 is a “health information company founded on the idea that more information, deeper analysis, and increased engagement will improve the diagnosis, treatment, and prevention of disease.”...

February 19th, 2018

Crohn’s disease is an inflammatory condition that affects the gastrointestinal tract and can cause symptoms including abdominal pain, diarrhoea, bleeding, joint pain, mouth sores, fatigue and weight loss. The cause is unknown but bacteria and the immune system are implicated and there is often a family connection. Factors such as genetics, stress, viruses or smoking are also linked. T...

January 9th, 2018

Alzheimer’s is a disease, very much like cancer, that affects so many of us, if not directly then through the experience of a family member or friend. There are currently 5 million people in the US living with Alzheimer’s and given that the western population experiences increasingly longer life, it’s predicted that by 2050 this figure could reach 16 million. It is thought there are 44 mi...

December 13th, 2017

A story in the UK press on 21 November 2017, Cancer tests in supermarket car parks in bid to boost detection rates, elicited the comment from Diaceutics of “Now that’s progress!” Our vision is that better testing leads to better patient outcomes and earlier diagnosis in the patient journey is a big part of that. The article also stimulated an animated discussion on public health policy. T...

December 11th, 2017

If you’re going to take part in a charity cycle race for cancer, then where better than California? This was the sunny setting for Ewelina Golebiewska and John McNamara from Diaceutics as they joined Team Pfizer in November 2017 on the two-day Padres Pedal the Cause event. “The scenery was amazing and the atmosphere even better, plus we had super supportive crowds cheering us on”, re...

December 5th, 2017

If you’ve ever had a blood test or a biopsy and questioned the time it takes to receive the results, the answer could be because the process involved can be more complex than you’d imagine, especially when a sample requires testing not once, but up to four times. Even though the range of diagnostic tests now available has increased significantly, and the analytical processes have seen immen...

November 30th, 2017

Precision or personalized medicine is taking us into an era of unprecedented breakthroughs in patient treatment and its progress depends to a great extent upon the best possible diagnostic testing. Optimizing test implementation at the laboratory level can be achieved efficiently and these improvements can directly impact and shape testing and patient outcomes. Real-time testing data suggest th...

November 17th, 2017

The ultimate aim of precision medicine is to treat a patient with a drug that perfectly fits their disease and genetic make-up. It is intended to target the disease or tumor, acting on that part of the body alone and causing minimal side effects. It’s a wonderful concept and we are beginning to see this become a reality with important advances in immuno-oncology, gene therapy and other incred...

November 13th, 2017

Think of all the rules you need to follow, and all the steps you need to take, in order to make a successful life partnership flourish. In precision medicine, where patients get diagnostic tests to establish their suitability for a specific therapy, getting the partnership right between diagnostic and pharmaceutical companies is similarly complex and challenging. However, doing it successfully ...

November 1st, 2017

During the last few years there has been intense debate about the biomarker PD-L1. It has become a significant feature of precision medicine but its uptake in diagnostic testing has been affected by a number of factors such as availability in labs, confusion over testing options, the platforms required and the interpretation and reporting of results. It’s a situation Diaceutics has been fo...

November 1st, 2017

With another FDA approval for Merck’s Keytruda, this time for gastric cancer, we see the onward march of PD-L1 therapy development. This time the therapy has been approved alongside the Agilent Technology companion diagnostic 22C3 pharmDx kit to test for PD-L1 IHC. When a therapy is approved for a new indication, pharma companies can benefit from an in-depth landscape analysi...

October 19th, 2017

The diagnostic approval process is an essential part of the commercialization and regulation of novel tests. Tests have to be approved for use by regulatory authorities and getting that approval can be a lengthy and complex process. This is made more complicated by the fact that different global regions enforce their own processes, and these regulations are constantly evolving. It is, therefore...

October 16th, 2017

Ewelina Golebiewska of Diaceutics, is swapping her lab coat for lycra in November 2017 as she takes on the uphill challenge of the Padres Pedal The Cause charity cycle race in San Diego, California. Alongside colleague John McNamara, she’ll be joining Team Pfizer to ride 156 miles over two days in the stunning California landscape. The weekend event donates 100 per cent of the money raised to...

October 12th, 2017

When it came to accepting a challenge, Shilpa Haridas, Director of Operations at Diaceutics, went for the ‘ignorance is bliss’ approach and willingly signed up for the Great North Run in September 2017. This iconic event takes place in the North East of England and is now the world’s largest half marathon. Shilpa had always enjoyed running and found it to be a calming activity but had nev...

October 12th, 2017

As precision medicine continues to promise a new future for healthcare, pharma companies need to put the teams and budgets in place to launch and commercialize their latest targeted therapies. As these therapies will likely need a companion diagnostic to identify the patients most suited to the treatment, there should also be plans in place to develop and launch the diagnostic at the same time....

September 29th, 2017

At Diaceutics, we know our support for integrated diagnostic testing by pharma companies is inextricably linked to improving patients’ access to testing and the right targeted therapy. The basic premise of precision or personalized medicine is that people are tested at the proper time in the course of their treatment pathway so that the right drug can be identified and prescribed as early as ...

September 29th, 2017

The time of the old and well-known ‘one-size-fits-all’ approach to therapy is being overtaken by precision medicine and the commercialization of multiple targeted therapies. We are now in an era in which the coexistence of diagnostics and biomarker detection on the treatment pathway is not an option, but mandatory. With regulatory authorities now favoring submission of therapy for approval ...

August 31st, 2017

Huge congratulations to Philip White, Chief Financial Officer of Diaceutics, who took part in the Prudential Ride London-Surrey 100 event in July 2017. On a beautiful day, Philip took to the streets and hills with his teammates and thousands of other cyclists, following the course set for the 2012 London Olympics. Amazingly, this was his first ever cycle race after only taking up the sport in A...

June 26th, 2017

Next Generation Sequencing (NGS), which is becoming more widely known as Comprehensive Genomic Profiling by Massively Parallel Sequencing (CGP), is set to significantly contribute to targeted therapy prescribing and complement other testing methods by 2020. Many genes are analysed simultaneously and it has the potential to detect all mutations in a patient specimen. However, the speed and sprea...

June 19th, 2017

Next Generation Sequencing (NGS), which is becoming more widely known as comprehensive genomic profiling by massively parallel sequencing (CGP), is set to significantly contribute to targeted therapy prescribing and complement other testing methods by 2020. Many genes are analysed simultaneously and it has the potential to detect all mutations in a patient specimen. However, the speed and sprea...

May 25th, 2017

Next Generation Sequencing (NGS), which is becoming more widely known as Comprehensive Genomic Profiling by Massively Parallel Sequencing (CGP), will significantly contribute to targeted therapies and precision medicine. We provide a brief snapshot of what NGS/CGP is, how it works, where it is being used, the potential difficulties and what’s on the horizon. What is Next Generation Sequencing...

May 11th, 2017

For someone who bought his first bike in April, competing in the Prudential Ride London-Surrey 100 race on July 30 2017 is certainly a challenge, but this is the attraction for Philip White, Chief Financial Officer, Diaceutics. Spurred on by the determination to raise funds for a charity very close to his heart, Philip will be following the same route taken by the world’s cycling legends at t...

May 4th, 2017

The FT US Healthcare and Life Sciences Summit in New York, now in its sixth successful year, will bring together industry leaders from across the healthcare and life sciences continuum to explore the major transformations ahead. Peter Keeling, CEO of Diaceutics, will be speaking at the May 2017 event on Leveraging diagnostics and analytics (Dx) to boost therapy return on investment – a 360° re...

April 26th, 2017

In regular Pharma Readiness reports Diaceutics analyses the global marketplace for diagnostic integration, summarizing the year that’s gone and making predictions for the months ahead. But given our unique position as thought leaders in the space, with inside knowledge of the diagnostic, pharmaceutical and laboratory industries, we have gone into more detail in the Ebook, Pharma Readiness for D...

April 18th, 2017

The US Food and Drug Administration announced on 6 April, 2017 that it has “allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to ...

April 13th, 2017

Since inception, Diaceutics has been involved in more than 200 drug launches and currently has a 60% share in the top 10 global markets. We currently count 26 out of the world’s top 30 pharmaceutical companies as clients and provide oversight, analysis and tracking of testing in 23 markets, every year helping 48,000 cancer patients access the personalized medicine that is right for them. Our ...

April 4th, 2017

The regular Pharma Readiness reports produced by Diaceutics aim to capture a snapshot of the diagnostic and precision medicine industries at certain times in a fast-evolving landscape. Pharma Readiness for Diagnostic Integration 2017 is no exception and discusses such vital topics as: Trends, best practice and preferred organizational styles in diagnostics (Dx) and precision medicine (PM) Thera...

March 21st, 2017

In the article Immuno-Oncology Drug Rivalries Highlight Biomarkers Opportunities, Challenges published in The MedTech Strategist (March 2017), the rivalries between big pharma and their biomarkers are highlighted. The battle between Merck and BMS around their Keytruda and Opdivo therapies in particular could mark “a potential turning point for the molecular diagnostics industry, which has sin...

March 13th, 2017

In an article for Clinical Lab Products magazine, The Evolution of the PD-L1 Testing Market, Peter Keeling and Ewelina Golebiewska examine how the extraordinarily dynamic PD-L1 space is providing opportunities to undertake real-time market analysis and ultimately improve our understanding of novel biomarker adoption. This active approach to real-time analysis, combined with the insights of a de...

March 13th, 2017

Implementation of biomarker testing is key to the success of precision medicine. The success of therapies based on immuno-oncology, with over six indications in recent years (predominantly lung cancer), has highlighted the need for PD-L1 biomarker testing and the challenges it raises for implementation. In our February 2017 webinar we discuss the adoption of PD-L1 testing in Europe using German...

December 20th, 2016

When a new year arrives many of us make lists about giving up this or starting that, but at Diaceutics we write a list about what we think will happen in the world of precision medicine (PM) and targeted therapies. In an ever-changing diagnostic landscape there are plenty to choose from but here are our top ten predictions.   Patient empowerment and patient centric approaches It’s easy to for...

November 25th, 2016

Those of us involved in personalized or precision medicine (PM) understand the huge impact it should have on everyone’s life and healthcare in general if all the stakeholders work for the good of the patient. This ideal represents the end of the journey but inevitably we are focussed on the practical demands of the next few stages. And the highly specialized nature of the space means we tend ...

PDL1 market blog image
November 10th, 2016

  The significant interest shown in the Diaceutics webinar How Can Analytics Help Avoid the PD-L1 Chaos: 10 Years of Insights is evidence of the widespread impact PD-L1 testing is already having on personalized medicine. Many of the issues surrounding PD-L1 that are discussed in the webinar have been seen in previous biomarker programs, but for the first time we have been able to track the clin...

November 8th, 2016

    Working out how to guide your company into the personalized medicine future can be a daunting, even overwhelming task – perhaps best to put it on hold…. But since President Obama announced to the US and the world in 2015 that personalized medicine (PM) was the way to go, it’s time to admit that this is really happening and it would be wise not to ignore it any longer. Diaceutics has bee...

October 5th, 2016

It’s easy to forget or even be unaware that laboratories are a crucial cog in personalized medicine. Obviously they run the diagnostic tests that determine which treatment will suit a patient, and they may also develop these tests, but their influence becomes clear when we recognise that they also connect with physicians at the laboratory-physician interface (LPI). The LPI is a primary and un...

September 14th, 2016

  The term competitive intelligence conjures up images of spies, undercover work and self-destructing messages. In some companies the concept may be so under the radar, or more likely underfunded, as to be almost a genuine secret, but for many pharma companies it plays a crucial role in their market research methods.   What is this intelligence and why is it needed? Hiding in a mountain of big ...

August 21st, 2016

While personalized medicine is what we at Diaceutics eat, sleep, and breathe, that’s not the case for everyone else, whether they be in pharma or just generally interested in health care, medicine and science. Luckily, we’ve got everyone covered. Now that we’re well into the second half of 2016, we’ve rounded up the top personalized medicine posts of the year so far so to keep you up to...

August 10th, 2016

Access to diagnostic tests and the subsequent reimbursement is an issue affecting all stakeholders in the fast evolving personalized medicine space. It’s an intricate web woven by drug companies, payers, insurance giants, laboratories and national health organizations. And once you think you have it sorted, you’re likely to face continuing adjustments and new considerations on pricing for e...

July 29th, 2016

Personalized medicine is becoming a part of everyone’s life. Its huge potential to change healthcare in the foreseeable future is exciting but often hard to shape given the many remaining barriers. And yet it increasingly enters our life, even if we or our loved ones are not currently receiving a personalized treatment. No week goes by without several major news stories on the topic. In just ...

July 19th, 2016

The companion diagnostic launch model is poised to become the go-to method of releasing targeted medications to the public. This approach will not only deepen public satisfaction and trust in your pharmaceutical company but also increase profit margins by targeting your research and development efforts. Here are the reasons why: 1. Simultaneous launches for companion diagnostics that are couple...

July 1st, 2016

Financial analysts have good reason to anticipate the continued growth of personalized medicine. Not only is it affecting patients and physicians but it holds plenty of promise for the pharma industry. General Strategic Development Benefits Personalized medicine encourages more vertical collaboration throughout the industry. It is therefore in the best interest of pharma companies to work more ...

June 14th, 2016

While 2015 was a record year for pharma partnerships, only a fraction of those were focused on commercialization. Competitive pressures are increasing, and pharma launches are becoming less predictable. Gain insight on partnering trends in personalized medicine and solutions for a successful partnering strategy with our new infographic. Did You Love It? Share This Infographic On Your Site <p><s...

June 10th, 2016

Companion diagnostics are diagnostic tests that provide information to guide the use of a corresponding therapy. These days, the ‘one therapy fits all’ approach to medicine has been demonstrated to be insufficient. Trial and error is often used to select a therapy for a specific person. Companion diagnostics aim to eliminate this by identifying patients who will particularly benefit from or...

June 2nd, 2016

The product launch is a moment of truth when it comes to the longevity of any pharmaceutical company. If a company manages a launch well, all of its recent shortcomings are forgiven and even patent cliffs become less scary. For the companies who will lead the way in the next century, pharmaceutical launches will look very different due to more restrictive market access and an emphasis on person...

Top Dx FInancial Planning Mistakes You Must Avoid
May 24th, 2016

When it comes to financial planning in the pharmaceutical industry there are five common mistakes that must absolutely be avoided. To understand how to remedy these mistakes, it helps to realize that one is an overarching problem in pharma financial planning, and the other four are contributing problems to this. They are: Failing to carefully vary the annual strategy and budget each year Neglec...

May 17th, 2016

For the last decade or so, much attention has been focused on personalized medicine; a modern approach that uses an individual’s genetic make-up to create a more targeted therapy or treatment. This advancement in genetics and biochemistry promises to bring to light the factors that explain why some patients largely benefit from therapy while others do not; and even in some cases go ahead to ex...

May 13th, 2016

Companion diagnostic services and personalized medicine are quickly revolutionizing the way that drugs are researched, created and marketed. To be prepared for these changes, it’s vital to understand the trends at work in the industry: Here’s what you need to know. 1. Applicability – and Demand – are Growing Quickly Personal and companion diagnostic services have seen a rapid rise in popula...

April 19th, 2016

As everyone in the industry knows, the pharmaceutical business model is far more complicated than most. It is not simply a case of developing a product, making a cost analysis, researching the competition then bringing the product to market. In pharma, the R&D phase can last 10 to 15 years from inception and a drug coming to market does not forecast its exact profit margin or future. Following ...

April 14th, 2016

The field of companion diagnostic treatments is still an emerging one and with all things new, preconceived ideas about novel therapeutic approaches and its associated technology can hinder natural acceptance and progress. In addition, a common myth concerning the launch of companion diagnostics has begun to surface. Myth: The regulatory hurdles and expense of implementing a new companion diagn...

Expert Insights

April 19th, 2018
The CMS National Coverage Decision on NGS
I. Introduction On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) that cove...
January 19th, 2018
What does the EU IVD Regulation mean for companion diagnostics and LDTs?
Dave Smart, PhD, Director at Diaceutics, discusses the introduction of the EU IVD Regulation. While it is considered a necessary step, the Regulati...

Competitive Benchmarking Reports

March 16th, 2018
PM Readiness Report 2018 Summary
March 14th, 2017
Pharma Readiness for Diagnostic Integration 2017

Publications

September 11th, 2018
BRAF mutation testing in melanoma – Poster presented at European Congress of Pathology 2018
BRAF mutation testing in melanoma: a study including Austria, Germany and UK, highlighting concordance for current technologies, and potential requirement of more sensitive technologies in future applications.
August 3rd, 2018
A Way Forward: Leveraging Advanced Diagnostic Testing to Unlock the Value of Precision Medicine
Read about how advanced diagnostic testing, ensuring that right patient gets the right therapy, at the right time, particularly with respect to therapies where the test result determines whether or not the therapy should be used (precision medicin...

Latest News

Latest News

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