Tissue Phenomics Blog

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Topics:  companion diagnostics, precision medicine, IVD, LDT, CDx strategy

Does it always take an IVD to be a CDx

Jul 10, 2017 7:30:00 AM

From the dawn of the Precision Medicine Age, pathologists have relied upon in vitro diagnostics (IVDs) to inform treating physicians of possible therapy options for cancer patients. From tests for HER2, EGFR, KRAS, and other biomarkers, IVDs have been more than sufficient to generate the necessary information to enable physicians to make educated treatment decisions. However, in the last few years, two pharmaceutical companies have successfully launched a drug with a sole-source lab commercializing a laboratory developed test (LDT). The first was AstraZeneca launching Lynparza™ requiring the use of Myriad Genetics’ BRACAnalysis CDx™ in December 2014, and the second was Clovis Oncology launching Rubraca™ requiring the use of Foundation Medicine’s FoundationFocus™ CDxBRCA in December 2016. It is still too early to know whether or not launching a CDx as a LDT is a new and sustainable trend, but it begs the question: Why would a pharma company select a lab as a CDx partner over an IVD manufacturer?

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