NEW YORK (GenomeWeb) – Biocept said today that it has partnered with the University of California, San Diego on a clinical validation study of the company's Target Selector PD-L1 assay in patients diagnosed with non-small cell lung cancer (NSCLC).
The Target Selector technology is designed to analyze both circulating tumor cell and circulating tumor DNA biomarkers from a blood sample, while the firm's PD-L1 assay is designed to detect and monitor programmed death-ligand 1 protein expression throughout the course of a patient's treatment with immuno-oncologic drugs.
Under the terms of the deal, UCSD's Sandip Patel will lead a 100-patient trial evaluating the assay in NSCLC patients using two antibody clones for PD-L1 detection — 28-8 and 22C3 — which Biocept said have the potential to offer high biomarker detection rates using liquid biopsy. The study's primary endpoint is concordance between tissue biopsy and liquid biopsy for the detection of PD-L1 protein expression, with correlation between treatment response and liquid biopsy-detected PD-L1 status as a secondary endpoint.
"To date, primarily tissue testing has been available to assess PD-L1 status, and this study attempts to broaden the use of liquid biopsies to encompass PD-L1 scoring, which is crucial in determining whether immunotherapy may be appropriate for a patient in a given disease setting," Patel said in a statement.