Case Studies | Diaceutics

Case Studies

Access specialist case studies covering all aspects of diagnostics, targeted therapies and business development
All
Commercialization
Diagnostics
Laboratories
Market Access
Marketing
Patients
Test
Testing
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...

What is Test Adoption?

This case study provides an overview of the core concepts of diagnostic adoption and its main drivers. It will also give you an understanding of how publications, guidelines and hands-on studies can impact on adoption and how diagnostics often un...

PM Educational Opportunity: Enabling Physician-Patient Communication

This case study describes the importance of informed communication. Physicians are the main source of information and advice for patients, however, many physicians are concerned about their ability to communicate test results and answer their pati...

Epzicom/HLA B*5701

This case study highlights GSK’s Epzicom and how, in some patients, it induced hypersensitivity which in turn contributed to a loss in market share. GSK initiated a hands-on study which showed that a diagnostic could be used to prevent the side ...

Selzentry/CCR5

This case study shows that a sub-optimal diagnostics strategy can impact on a drugs revenue. Using Selzentry as an example, it highlights how failure to address several key issues around testing logistics, such as test performance and slow turnaro...

Dx Regulatory Pathways in the US

This case study considers whether the test required to enable a therapy should be an LDT or an IVD kit and explains their different regulatory pathways. It will help you understand: Whether the test required to enable a therapy should be an LDT ...

Does Personalized Medicine Fit?

This case study is based on a patent-applied-for technique that generates, for a given drug, a numerical index relating to various aspects of suitability for a personalized (test-based) marketing strategy. This index is then compared to values der...

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...

Enabling Personalized Medicine Markets

This case study demonstrates how diagnostic strategies can significantly improve the return on investment of a therapy outside of drug response testing. It will help you understand: Three strategies that are worth considering to improve ROI Diffe...

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...

Zelboraf/Clinical Trial Length

This case shows how Rx/Dx co-development can enable faster regulatory approval and a shorter and cheaper clinical trial program. It highlights the particular features and success factors that enabled Roche to use a targeted strategy to streamline ...

Financial Drivers

This case study looks at how a number of diagnostic drivers can impact on a targeted therapy’s return on investment. It shows that it is important to have a robust and well-defined diagnostic strategy with an understanding of where diagnostic ...

Design Risks in Personalized Medicine: An Emphasis on Litigation

This case study will help you understand how personalized medicine will change the legal landscape in ways that are as yet uncharted. It also discusses the importance of reflecting on any potential areas of legal exposure and addressing these in t...

Personalized Medicine Educational Opportunity: Physicians’ Knowledge

Stakeholders in personalized medicine are currently missing out on the considerable opportunity to offer physicians information and education on molecular testing. This case study examines how the physicians’ education gap might impact on your Rx...

Test Reimbursement

This case study explains the global differences in test reimbursement and reveals that for some tests the laboratories own costs aren’t even covered. It concludes that pharma must sometimes commit to subsidized testing but in doing so will cre...

Dx Launch Risks

This case study shows how a risk management strategy for possible recalls could prevent disruption, not only to a biomarker’s market progress, but to an entire company. It will help you understand: How a risk management strategy for recalls should...

Partnering with Diagnostic Companies

This case study focuses on partnerships with diagnostics companies and why they need to be clearly defined. It outlines the core principles of partnering in the diagnostic space, highlighting the partner selection process steps and timelines that ...

The Public Side of Diagnostics

This case provides an overview of the global diagnostics industry and its potential for growth. It shows how the diagnostic market is complex and fragmented and that it is important to understand costs at every stage of the diagnostics value chain...

Personalized Medicine – The Future of Diagnostics

This case study provides an introduction to personalized medicine and its increasing relevance to the diagnostics industry, explaining core concepts, trends, awareness growth and major drivers of change. It will help you understand: Personalized m...

Xalkori/ALK

This case study highlights the importance of co-development and co-approval processes to achieve rapid approval of both the test and therapy. Using Xalkori and the development of an ALK test as an example, the case study recommends communications ...

Tysabri/JCV Antibodies

This case study shows how taking a proactive approach to risk stratification by means of a diagnostic test, even in the case of severe adverse events, can help rescue and reposition an otherwise highly effective drug. Using Tysabri as an example,...

Latest Blogs

Blogs

Webinars & Podcasts

August 20th, 2019
Podcast: How Diaceutics is repairing the diagnostic testing ecoystem for patients worldwide
Diaceutics CEO, Peter Keeling joins Pat Kenny on Newstalk FM to discuss how analyzing Big Data to implement better diagnostic testing can help patients access better treatment options for cancer and other life-threatening diseases.
July 5th, 2019
Liquid Biopsy in NSCLC

Publications

June 25th, 2019
FLT3 testing in relapsed Acute Myeloid Leukemia setting is becoming increasingly common, but laboratory turnaround times (TAT) may be a barrier to treatment with second generation FLT3 inhibitors
The treatment landscape in AML has developed at an astonishing pace in the last 3 years, with 5 therapies being approved by the FDA. FLT3 inhibitors gilteritinib (Gil) and quizartinib (Quiz) present an unprecedented opportunity for improved surviv...
May 23rd, 2019
Diaceutics reviews the ongoing debate on diagnostics reform legislation
Thought leaders at Diaceutics recently authored a peer-reviewed article that covers the ongoing national debate over diagnostics reform legislation in the United States. The article is now available online ahead of print in the Journal of Molecula...

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

October 21st, 2019
Pharma Precision Medicine Readiness Report 2019
March 16th, 2018
PM Readiness Report 2018 Summary
All
Commercialization
Diagnostics
Laboratories
Market Access
Marketing
Patients
Test
Testing
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...

What is Test Adoption?

This case study provides an overview of the core concepts of diagnostic adoption and its main drivers. It will also give you an understanding of how publications, guidelines and hands-on studies can impact on adoption and how diagnostics often un...

PM Educational Opportunity: Enabling Physician-Patient Communication

This case study describes the importance of informed communication. Physicians are the main source of information and advice for patients, however, many physicians are concerned about their ability to communicate test results and answer their pati...

Epzicom/HLA B*5701

This case study highlights GSK’s Epzicom and how, in some patients, it induced hypersensitivity which in turn contributed to a loss in market share. GSK initiated a hands-on study which showed that a diagnostic could be used to prevent the side ...

Selzentry/CCR5

This case study shows that a sub-optimal diagnostics strategy can impact on a drugs revenue. Using Selzentry as an example, it highlights how failure to address several key issues around testing logistics, such as test performance and slow turnaro...

Dx Regulatory Pathways in the US

This case study considers whether the test required to enable a therapy should be an LDT or an IVD kit and explains their different regulatory pathways. It will help you understand: Whether the test required to enable a therapy should be an LDT ...

Does Personalized Medicine Fit?

This case study is based on a patent-applied-for technique that generates, for a given drug, a numerical index relating to various aspects of suitability for a personalized (test-based) marketing strategy. This index is then compared to values der...

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...

Enabling Personalized Medicine Markets

This case study demonstrates how diagnostic strategies can significantly improve the return on investment of a therapy outside of drug response testing. It will help you understand: Three strategies that are worth considering to improve ROI Diffe...

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...

Zelboraf/Clinical Trial Length

This case shows how Rx/Dx co-development can enable faster regulatory approval and a shorter and cheaper clinical trial program. It highlights the particular features and success factors that enabled Roche to use a targeted strategy to streamline ...

Financial Drivers

This case study looks at how a number of diagnostic drivers can impact on a targeted therapy’s return on investment. It shows that it is important to have a robust and well-defined diagnostic strategy with an understanding of where diagnostic ...

Design Risks in Personalized Medicine: An Emphasis on Litigation

This case study will help you understand how personalized medicine will change the legal landscape in ways that are as yet uncharted. It also discusses the importance of reflecting on any potential areas of legal exposure and addressing these in t...

Personalized Medicine Educational Opportunity: Physicians’ Knowledge

Stakeholders in personalized medicine are currently missing out on the considerable opportunity to offer physicians information and education on molecular testing. This case study examines how the physicians’ education gap might impact on your Rx...

Test Reimbursement

This case study explains the global differences in test reimbursement and reveals that for some tests the laboratories own costs aren’t even covered. It concludes that pharma must sometimes commit to subsidized testing but in doing so will cre...

Dx Launch Risks

This case study shows how a risk management strategy for possible recalls could prevent disruption, not only to a biomarker’s market progress, but to an entire company. It will help you understand: How a risk management strategy for recalls should...

Partnering with Diagnostic Companies

This case study focuses on partnerships with diagnostics companies and why they need to be clearly defined. It outlines the core principles of partnering in the diagnostic space, highlighting the partner selection process steps and timelines that ...

The Public Side of Diagnostics

This case provides an overview of the global diagnostics industry and its potential for growth. It shows how the diagnostic market is complex and fragmented and that it is important to understand costs at every stage of the diagnostics value chain...

Personalized Medicine – The Future of Diagnostics

This case study provides an introduction to personalized medicine and its increasing relevance to the diagnostics industry, explaining core concepts, trends, awareness growth and major drivers of change. It will help you understand: Personalized m...

Xalkori/ALK

This case study highlights the importance of co-development and co-approval processes to achieve rapid approval of both the test and therapy. Using Xalkori and the development of an ALK test as an example, the case study recommends communications ...

Tysabri/JCV Antibodies

This case study shows how taking a proactive approach to risk stratification by means of a diagnostic test, even in the case of severe adverse events, can help rescue and reposition an otherwise highly effective drug. Using Tysabri as an example,...

Blogs

Webinars & Podcasts

August 20th, 2019
Podcast: How Diaceutics is repairing the diagnostic testing ecoystem for patients worldwide
Diaceutics CEO, Peter Keeling joins Pat Kenny on Newstalk FM to discuss how analyzing Big Data to implement better diagnostic testing can help patients access better treatment options for cancer and other life-threatening diseases.
July 5th, 2019
Liquid Biopsy in NSCLC

Publications

June 25th, 2019
FLT3 testing in relapsed Acute Myeloid Leukemia setting is becoming increasingly common, but laboratory turnaround times (TAT) may be a barrier to treatment with second generation FLT3 inhibitors
The treatment landscape in AML has developed at an astonishing pace in the last 3 years, with 5 therapies being approved by the FDA. FLT3 inhibitors gilteritinib (Gil) and quizartinib (Quiz) present an unprecedented opportunity for improved surviv...
May 23rd, 2019
Diaceutics reviews the ongoing debate on diagnostics reform legislation
Thought leaders at Diaceutics recently authored a peer-reviewed article that covers the ongoing national debate over diagnostics reform legislation in the United States. The article is now available online ahead of print in the Journal of Molecula...

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

October 21st, 2019
Pharma Precision Medicine Readiness Report 2019
March 16th, 2018
PM Readiness Report 2018 Summary