Biocept Inc (NASDAQ:BIOC) announced plans Tuesday to collaborate with Protean BioDiagnostics Inc to research the ability of its own Target Selector molecular assays to determine the status of EGFR mutations in non-small cell lung cancer (NSCLC) patients.
Protean also expects to validate the analytical performance of a laboratory developed test (LDT) based on Biocept’s EGFR assay test kit in accordance with the requirements of the College of American Pathologists (CAP) validation process, the company said. The research is expected to be conducted in an independent pathology laboratory setting.
Biocept’s novel molecular assay kit enables laboratories to analyze both formalin-fixed paraffin-embedded (FFPE) tissue samples and circulating tumor DNA (ctDNA) from biological fluids by utilizing its Target Selector platform. Target Selector uses patented Switch-Blocker technology to enrich tissue specimens for mutations of interest and block DNA amplification from normal cells, meaning higher sensitivity and a smaller required tumor sample size.
"We are pleased to collaborate with Biocept to demonstrate the potential of its assay in determining EGFR status," Protean CEO Anthony Magliocco said in a statement. "Obtaining adequate tissue samples for genomic profiling continues to be a challenge in first-line therapy selection for patients with NSCLC.”
READ: Biocept to present study showcasing its ultra-sensitive Target Selector biopsy assay kits at a virtual medical conference this week
“Target Selector EGFR assays require 50% less tumor input sample than most commercial assays, making it a potentially powerful tool in helping qualify more patients for targeted tyrosine kinase inhibitor, or TKI, therapy,” Magliocco added. “This potential advantage is coupled with previous studies demonstrating Target Selector assays’ best-in-class low-end limit of detection of mutations in both FFPE and liquid biopsy samples."
Biocept’s molecular assays have been validated for the detection of frequent oncogenic mutations EGFR, KRAS and BRAF, which are among the most frequently evaluated biomarkers for lung cancer and melanoma, the company said.
"Protean BioDiagnostics is the ideal partner for this collaboration, as we share a joint commitment to advancing the best possible care for patients with cancer," Biocept CEO Michael Nall commented "Protean has extensive experience working with some of the world’s leading biotechnology companies. Together, our goal is to demonstrate how Target Selector assays can help physicians create more personalized, responsive treatment plans for their patients."
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