Biocept and Protean BioDiagnostics Establish Research Collaboration to Demonstrate Advantages of Biocept’s Target Selector Assay Kit for Non-Small Cell Lung Cancer Patients

Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, will collaborate with Protean BioDiagnostics Inc. to research the ability of Biocept’s Target Selector molecular assay to determine EGFR status in non-small cell lung cancer (NSCLC) patients. The research will be conducted in an independent pathology laboratory setting.

Protean BioDiagnostics 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.

Biocept’s novel molecular assay kit, available for research-use-only and with CE-IVD mark, enables molecular laboratories around the world to utilize its Target Selector platform to analyze both formalin-fixed paraffin-embedded (FFPE) tissue samples and circulating tumor DNA (ctDNA) from biological fluids. Target Selector leverages patented Switch-Blocker technology to enrich specimens for mutations of interest and block DNA amplification from normal cells, requiring less tumor sample and resulting in higher assay sensitivity than most commercial assays. 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.

“We are pleased to collaborate with Biocept to demonstrate the potential of its assay in determining EGFR status,” said Anthony M. Magliocco, MD, President and CEO of Protean BioDiagnostics. “Obtaining adequate tissue sample for genomic profiling continues to be a challenge in first-line therapy selection for patients with NSCLC. 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. 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.”

“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,” said Michael Nall, Biocept President and CEO. “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.”