Biodesix Announces PD-L1 Collaboration with Professor Fred R. Hirsch

New PD-L1 Study Data Presented at ASCO-SITC Annual Meeting

 Biodesix^® announced a new collaboration agreement with PD-L1 expert Professor Fred R. Hirsch, MD, PhD, laboratory director at the Hirsch Biomarker Laboratory at the University of Colorado Cancer Center in Aurora, CO. Dr. Hirsch’s lab will provide analysis of prospectively collected tissue samples with matched plasma from patients diagnosed with non-small cell lung cancer (NSCLC). The announcement follows a poster presented by Biodesix, including preliminary data evaluating a blood-based PD-L1 liquid biopsy test in development that uses plasma-derived RNA. The data were presented last week at the ASCO-SITC conference.

“The results of our pilot prospective study led us to conclude that although the development of a blood-based PD-L1 mRNA assay was achieved, de-centralized IHC methods may not be the most suitable way to assess the clinical utility of RNA blood assays,” said Dr. Gary Pestano, Vice President of Development for Biodesix. “IHC testing for PD-L1 expression is a complex undertaking and it has many challenges,” added Dr. Hirsch. “Some of these are technical in nature and related to the number of antibodies used to perform IHC and variability in pathologists’ interpretation. We are very happy to be working with the Biodesix team and their physician collaborators on expanding their studies in our centralized IHC testing Laboratory.”

PD-L1, or programmed cell death ligand-1, is an important protein biomarker; when overexpressed in cancer patients, PD-L1 is a target for specific immunotherapies called checkpoint inhibitors. Several such therapies have received FDA approval.

The study, “Performance verification of a plasma-based PD-L1 test that reliably measures mRNA expression from patients with NSCLC,” refers to a test in development at Biodesix that uses multiplexed droplet digital™ PCR (ddPCR) detection of circulating PD-L1 mRNA. The data demonstrates the robustness of the PD-L1 RNA assay from blood.

About Biodesix

Biodesix^® is a molecular diagnostics company advancing the development of innovative, multiomic blood tests in oncology to enable precision medicine. Biodesix discovers, develops and commercializes multivariate protein and genomic liquid biopsy tests, including the

GeneStrat^® and VeriStrat^® tests, that deliver results within 72 hours. The company is changing the standard of care by providing physicians with diagnostic tests and with the Biodesix Lung Reflex™ testing strategy, for better therapeutic guidance, more accurate prognosis and enhanced disease monitoring to improve patient outcomes. At the forefront of personalized medicine, Biodesix is developing new tests to identify patients who may benefit from immunotherapies. In addition to developing novel diagnostics independently, the company partners with biotechnology and pharmaceutical companies to develop companion diagnostics for use with therapeutic agents.