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Blood-based Diagnostic Assay from Biodesix Measures Immunotherapy Biomarker PD-L1

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New data from Biodesix® evaluating an assay in development demonstrated the potential to measure circulating PD-L1 through mRNA in blood through multiplexed droplet digital™ PCR (ddPCR, Bio-Rad, Inc.) detection. The assay uses proprietary RNA isolation methods consistent with Biodesix’s commercialized GeneStrat® ALK, ROS1, and RET variant tests. Existing immunohistochemistry (IHC) PD-L1 tissue tests are used to identify patients who may benefit from cancer immunotherapies. The data were presented last week at the ASCO-SITC Clinical Immuno-Oncology Program in Orlando, Florida.

“Understanding PD-L1 status is a central question in immuno-oncology, and obtaining a reliable result will provide vital insight for patients and their physicians,” said Dr. Michael Pritchett, Director of the Chest Center of the Carolinas at FirstHealth Moore Regional Hospital in Pinehurst, North Carolina. “Combining PD-L1 results with the existing blood-based offering that includes driver mutations provides a rapid, non-invasive testing option to inform treatment decisions.”

PD-L1 has been detected in up to 50% of all human cancers and has become a major focus of therapeutic and biomarker research.1 Patients whose tumors over-express the PD-L1 protein are more likely to respond to certain immuno-oncology therapeutics, and several PD-L1-related therapies have received FDA approval. These checkpoint inhibitors are widely anticipated to provide the backbone for rapidly evolving approaches to immuno-oncology. With IHC tests, higher levels of PD-L1 protein have been correlated with higher likelihood of response for a number of tumor types.

The assay was described in the study, “Development of ddPCR blood-based diagnostic tests that simultaneously measure mRNA expression from immune and cancer cells.” The GeneStrat test offers accurate, non-invasive blood-based mutation results with a 72-hour turnaround time for patients with non-small cell lung cancer, delivering rapid information for diagnosis or therapy monitoring to identify specific driver mutations with proven clinical utility.

Source: Business Wire