Thought Leadership | Diaceutics

Thought Leadership

Blogs

October 18th, 2018

The clinically most useful MRD test and targets are not yet determined.1 More accurate methods to measure MRD are being developed and MRD testing is now part of standard treatment regime for some diseases such as ALL and is being validated for other conditions including acute myeloid leukemia (AML). MRD is persistent disease. Current MRD techniques include first-generation flow, next generatio...

October 18th, 2018

The FDA has established the Biomarker Qualification Program (BQP) to work with external stakeholders to develop and qualify measurable and reliable biomarkers for a specific use in drug development. Under the BQP process a manufacturer submits evidence to the FDA providing details about the biomarker, the context of use, measurements and unmet need. The FDA accepts the submission when there i...

Expert Insights

April 19th, 2018
The CMS National Coverage Decision on NGS
Jeff Schreier
Robert Feeney
I. Introduction 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 Sequencing (NGS) for patients with advanced cancer. In addition to covering the FDA-approved FoundationOne CDx™ (F1CDx), CMS is now covering other FDA-approved or cleared companion in vitro diag...
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...
September 1st, 2017
Liquid biopsy: clearing the barriers to support pharma, labs and patients
There was considerable discussion around liquid biopsy at ASCO 2017 at a time when questions about its clinical utility are still to be addressed. ...

Competitive Benchmarking Reports

March 14th, 2017
Pharma Readiness for Diagnostic Integration 2017

This report asks which pharma companies are ready for diagnostic integration and draws on benchmarking and financial risk assessment. Its analyses of 23 companies, plus therapies on the market and in the pipeline, provide a 360° view of diagnostic-dependent therapy assets. It features big data and lab partnerships alongside therapy/diagnostic partnerships to reflect the evolution of precisio...

March 24th, 2016
Pharma Readiness for Personalized Medicine Summary Report 2016

This report is a quantitative and qualitative assessment of pharma readiness to operate in a personalized medicine marketplace. It is a summary update to the 2015 Pharma Readiness for Personalized Medicine Report which examined how prepared pharmaceutical companies are for the emerging personalized medicine business model. This report specifically examines the revenue achievements and business ...

Case Studies

Laboratories – the forgotten stakeholder

“Pathologists and laboratories are often overlooked as key stakeholders by pharma and this factor can have a considerable impact on the uptake of targeted therapies.” This case study considers the role of laboratories in relation to uptake, includ...

An Inside Look at Diagnostics

This case study illustrates the evolution of the diagnostic industry across different continents, diagnostic companies’ evolving business models, stakeholder networks and the critical drivers of personalized medicine adoption in the diagnostic ind...

Marketing Overview

It is often assumed that the availability of a clinically meaningful laboratory test will drive its use. However, Diaceutics’ adoption research has shown the importance of proactive marketing and awareness-building initiatives around the launch of...

Herceptin/HER2

This case study shows why a pharma company with an Rx asset dependent on a test should take a proactive approach to managing the Dx environment from the outset, in order to drive adoption and avoid implementation flaws. Reviewing Herceptin, the c...

Our Thought Leadership

Webinars & Podcasts

August 9th, 2018
Podcast: Oncology Patient Research
Why do we need to talk biomarkers with patients? Senior Director of Market Research at Diaceutics, Marianne Fillion, recently spearheaded an effort to gather insights directly from oncology patients to get an understanding of what they know about ...
April 20th, 2018
Podcast: PM Readiness Report 2018
Peter Keeling discusses the landscape and challenges for precision medicine, companion diagnostics, CDx or biomarker and conduit diagnostics are discussed including global laboratory test data analysis and forecasts for budget impact and value.

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...

Ebooks

September 29th, 2017
PD-L1: The Story So Far
PD-L1 has been one of the most talked about new biomarkers in the context of targeted therapy. This Ebook looks at the dynamic PD-L1 space and discusses topics such as test availability, integration alongside more established biomarkers, complementary testing and how a suboptimal PD-L1 diagnostic marketplace can lead to lost treatment opportunities.
June 30th, 2017
Better Testing
A shift to value-based pricing for drugs in the US market has been much anticipated by payers and the pharma industry alike. However, better testing has not featured adequately in the debate to date. This Ebook contains articles and discussion from Diaceutics on how better testing can play a central role in achieving the optimal economic model.

Ebooks

June 30th, 2017
Better Testing
A shift to value-based pricing for drugs in the US market has been much anticipated by payers and the pharma industry alike. However, better testing has not featured adequately in the debate to date. This Ebook contains articles and discussion from Diaceutics on how better testing can play a central role in achieving the optimal economic model.
April 4th, 2017
Pharma Readiness for Diagnostic Integration 2017
Being at the heart of the diagnostics space, Diaceutics is perfectly placed to not only analyse and comment on the precision medicine world in real-time but to make informed and thought-provoking predictions for the years ahead. This collection of opinion pieces written for Pharma Readiness for Diagnostic Integration 2017 looks at the key trends likely to shape the pharma/diagnostic interface ...
September 29th, 2017
PD-L1: The Story So Far
PD-L1 has been one of the most talked about new biomarkers in the context of targeted therapy. This Ebook looks at the dynamic PD-L1 space and discusses topics such as test availability, integration alongside more established biomarkers, complementary testing and how a suboptimal PD-L1 diagnostic marketplace can lead to lost treatment opportunities.
June 30th, 2017
Better Testing
A shift to value-based pricing for drugs in the US market has been much anticipated by payers and the pharma industry alike. However, better testing has not featured adequately in the debate to date. This Ebook contains articles and discussion from Diaceutics on how better testing can play a central role in achieving the optimal economic model.
April 4th, 2017
Pharma Readiness for Diagnostic Integration 2017
Being at the heart of the diagnostics space, Diaceutics is perfectly placed to not only analyse and comment on the precision medicine world in real-time but to make informed and thought-provoking predictions for the years ahead. This collection of opinion pieces written for Pharma Readiness for Diagnostic Integration 2017 looks at the key trends likely to shape the pharma/diagnostic interface ...
October 14th, 2016
Personalized Medicine: What Pharma Should Do To Get Ready
An essential component of personalized medicine is diagnostic (Dx) testing, which identifies the right patient for the right drug. The diagnostic industry is growing steadily, but what does it mean for the pharmaceutical industry and how can pharma seize this personalized medicine opportunity?

Expert Insights

April 19th, 2018
The CMS National Coverage Decision on NGS
Jeff Schreier
Robert Feeney
I. Introduction 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 Sequencing (NGS) for patients with advanced cancer. In addition to covering the FDA-approved FoundationOne CDx™ (F1CDx), CMS is now covering other FDA-approved or cleared companion in vitro diag...
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...
September 1st, 2017
Liquid biopsy: clearing the barriers to support pharma, labs and patients
There was considerable discussion around liquid biopsy at ASCO 2017 at a time when questions about its clinical utility are still to be addressed. ...

Competitive Benchmarking Reports

March 14th, 2017
Pharma Readiness for Diagnostic Integration 2017

This report asks which pharma companies are ready for diagnostic integration and draws on benchmarking and financial risk assessment. Its analyses of 23 companies, plus therapies on the market and in the pipeline, provide a 360° view of diagnostic-dependent therapy assets. It features big data and lab partnerships alongside therapy/diagnostic partnerships to reflect the evolution of precisio...

March 24th, 2016
Pharma Readiness for Personalized Medicine Summary Report 2016

This report is a quantitative and qualitative assessment of pharma readiness to operate in a personalized medicine marketplace. It is a summary update to the 2015 Pharma Readiness for Personalized Medicine Report which examined how prepared pharmaceutical companies are for the emerging personalized medicine business model. This report specifically examines the revenue achievements and business ...

March 16th, 2018
PM Readiness Report 2018 Summary

The landscape and challenges for precision medicine, companion diagnostics, CDx or biomarker and conduit diagnostics are discussed including global laboratory test data analysis and forecasts for budget impact and value.

March 14th, 2017
Pharma Readiness for Diagnostic Integration 2017

This report asks which pharma companies are ready for diagnostic integration and draws on benchmarking and financial risk assessment. Its analyses of 23 companies, plus therapies on the market and in the pipeline, provide a 360° view of diagnostic-dependent therapy assets. It features big data and lab partnerships alongside therapy/diagnostic partnerships to reflect the evolution of precisio...

March 24th, 2016
Pharma Readiness for Personalized Medicine Summary Report 2016

This report is a quantitative and qualitative assessment of pharma readiness to operate in a personalized medicine marketplace. It is a summary update to the 2015 Pharma Readiness for Personalized Medicine Report which examined how prepared pharmaceutical companies are for the emerging personalized medicine business model. This report specifically examines the revenue achievements and business ...

January 15th, 2016
Personalized Healthcare Brand Index Surveillance; Pharma Communication Trends for Companion Testing

This report is a unique study of the communication styles pharma uses for targeted therapy. The goal of this report was to determine who is educating about personalized healthcare in connection with therapy branding (initially in oncology) and to understand how the testing narrative around a brand is shaping current and evolving brand strategies. It’s not concerned with right or wrong but abo...

Case Studies

Laboratories – the forgotten stakeholder

“Pathologists and laboratories are often overlooked as key stakeholders by pharma and this factor can have a considerable impact on the uptake of targeted therapies.” This case study considers the role of laboratories in relation to uptake, includ...

An Inside Look at Diagnostics

This case study illustrates the evolution of the diagnostic industry across different continents, diagnostic companies’ evolving business models, stakeholder networks and the critical drivers of personalized medicine adoption in the diagnostic ind...

Marketing Overview

It is often assumed that the availability of a clinically meaningful laboratory test will drive its use. However, Diaceutics’ adoption research has shown the importance of proactive marketing and awareness-building initiatives around the launch of...

Herceptin/HER2

This case study shows why a pharma company with an Rx asset dependent on a test should take a proactive approach to managing the Dx environment from the outset, in order to drive adoption and avoid implementation flaws. Reviewing Herceptin, the c...

Blogs

Webinars & Podcasts

August 9th, 2018
Podcast: Oncology Patient Research
Why do we need to talk biomarkers with patients? Senior Director of Market Research at Diaceutics, Marianne Fillion, recently spearheaded an effort to gather insights directly from oncology patients to get an understanding of what they know about ...
April 20th, 2018
Podcast: PM Readiness Report 2018
Peter Keeling discusses the landscape and challenges for precision medicine, companion diagnostics, CDx or biomarker and conduit diagnostics are discussed including global laboratory test data analysis and forecasts for budget impact and value.

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...
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