Dr. Shiller on the Challenges in the Development of NSCLC Biomarkers

Shirley Michelle Shiller, DO, member of the Precision Medicine Institute's Advisory Committee, Baylor University Medical Center, discusses the difficulties that are preventing a more streamlined approached in testing for biomarkers.

Some of the main challenges that physicians are facing are the FDA issuing companion diagnostics without adequately engaging the pathologist in terms of its performance characteristics. Physicians also need to work together to streamline which markers are being used, such as PD-L1.

Though there are FDA companion diagnostics in other spaces, for years the testing was also done in labs throughout the country with similar results—results that weren't overseen, governed, or given a companion diagnostic designation by the FDA.

Going forward, physicians have to develop a better level of communication with the FDA in terms of the performance of assays and help them understand that physicians are already governed by 2 other parties. Having a third party come into the mix may or may not be needed depending on the actual biomarker and how it’s going to be used.