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Biodesix, University of Colorado Partner on Lung Cancer Assay

NEW YORK (GenomeWeb) – Biodesix announced today that it has partnered with the University of Colorado Cancer Center to develop a blood-based assay designed to help identify non-small cell lung cancer (NSCLC) patients likely to respond to certain immunotherapies.

According to the company, it has been developing a test for PD-L1 — or programmed cell death ligand-1 — a protein that is overexpressed in certain cancer patients and which is targeted by some checkpoint inhibitor drugs. The test measures PD-L1 mRNA levels in circulation using multiplexed droplet digital PCR technology.

In a recent pilot study, the test was able to reliably measure PD-L1 mRNA expression in NSCLC patients, Biodesix said. However, it was determined that decentralized immunohistochemistry (IHC) methods "may not be the most suitable way to assess the clinical utility of RNA blood assays," Gary Pestano, vice president of development at Biodesix, said in a statement.

In light of these findings, Biodesix has partnered with CU Cancer Center researcher Fred Hirsch, whose lab will analyze prospectively collected tissue samples with matched plasma from patients diagnosed with NSCLC.

"IHC testing for PD-L1 expression is a complex undertaking and it has many challenges," Hirsch said in the statement. "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."

Late last year, Biodesix said that it had pushed back the timeline for a different test designed to guide immunotherapy in NSCLC patients in order to assess what clinical questions are likely to be the biggest challenges for the field.

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