PD-L1: The Story So Far | Diaceutics

PD-L1: The Story So Far

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 alongside diagnostic test development, the importance of biomarkers and diagnostic testing for pharma companies is becoming a top priority.

One of the most talked about new biomarkers in the context of targeted therapy has been PD-L1. Diaceutics began tracking PD-L1 testing in 2015 and our observations reveal that its integration into treatment pathways and drug launch programs, as is the case with other novel biomarkers, is not without problems. The PD-L1 space, which has been particularly dynamic, has provided opportunities to undertake real-time market analysis and improve our understanding of novel biomarker adoption. Interestingly, in the first 18 months post-launch, over 70 US labs started using the test, and that number continues to grow. This indicates that PD-L1 testing has a fast-track pattern of uptake in parallel with treatment recommendations.

Our new Ebook, PD-L1: The Story So Far, tracks the evolution of PD-L1 through a series of Expert Insights written by the Diaceutics team from 2015 to 2017, and examines topics including test availability, integration alongside more established biomarkers, complementary testing and how a suboptimal PD-L1 diagnostic marketplace can lead to lost treatment opportunities. A clear theme throughout is that while precision medicine continues to progress, we still suffer from the lack of pre-launch market development of critical diagnostics, even though most of the issues surrounding PD-L1 have been seen before.

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.
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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...
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Competitive Benchmarking Reports

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