Study Shows Biocept’s Target Selector Detects Mutations in “Quantity Not Sufficient” Specimens in Non-Small Cell Lung Cancer Patients

Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, will present data showing that its Target Selector molecular assay kit detects mutations in up to 50% of tissue biopsy specimens, from patients diagnosed with non-small cell lung cancer, that were deemed quantity not sufficient (QNS). The study will be presented at the Molecular Med Tri-Con Virtual Conference, Feb. 16-18, 2021.

Molecular testing of biopsy specimens is critical to identify genetic mutations and guide potential treatment with targeted therapies. However, in up to 40% of cases, specimens lack sufficient tissue to perform testing¹ and are deemed insufficient. The presence of non-tumor cells can also be an obstacle in detecting specific mutations. As a result, QNS specimens are a significant issue in molecular diagnostic testing and a key challenge faced by oncologists and pathologists in managing cancer patients.

The pilot study utilized Biocept’s Target Selector molecular assay with Switch-Blocker technology, which offers ultra-high sensitivity and requires less tumor sample than most commercial assays. The assay was used to evaluate the presence of several key EGFR and KRAS mutations in formalin-fixed paraformaldehyde embedded (FFPE) tissue slides, supplied by NeoGenomics Laboratories, Inc. that were deemed QNS for next generation sequencing (NGS) analysis. Results showed that EGFR mutations were detected in 50% (3/6) of patient samples, and KRAS mutations in 17% (1/6) of samples.

“We’re looking for rare mutations from a very small tissue sample in a large background of non-tumor cells to help us guide treatment decisions for patients,” said Michael C. Dugan, M.D., Senior Vice President, Chief Medical Officer and Medical Director of Biocept. “This collaboration with NeoGenomics confirms that our Target Selector assay used with FFPE samples has the potential to provide molecular results when other common platforms can’t, offering actionable information for physicians to help identify potential targeted therapy options.”

Biocept’s Target Selector assay kits, available for research-use-only and CE-IVD, detect mutations in DNA derived from FFPE or blood plasma to give insight into a patient’s cancer characteristics and provide tumor biomarker status. Target Selector utilizes patented Switch-Blocker technology to enrich specimens for mutations of interest and block DNA amplification from normal cells, resulting in ultra-high assay sensitivity and specificity compared to other methods currently used in laboratories. The kits allow molecular laboratories around the world to use Target Selector assays to detect key oncogene mutations through the analysis of both FFPE tissue from surgical biopsies and ctDNA from blood-based liquid biopsies. Biocept also offers Target Selector ctDNA-based tests in its CLIA-certified, CAP-accredited laboratory.