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.