On February 23, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that it 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 (Press release, Biocept, FEB 23, 2021, View Source [SID1234575485]). The research will be conducted in an independent pathology laboratory setting.
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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."
About Target Selector Molecular Assay Kits
Target Selector molecular assay kits are marketed for research-use-only (RUO) in the U.S. and CE-IVD in the European Union and other CE Mark geographies, offering industry-leading sensitivity for the detection of mutations/variants of interest in both FFPE and ctDNA. Target Selector assays with Switch-Blocker technology can also provide results with smaller DNA inputs (minimum 4.6 ng) than most tissue-based assays, allowing laboratories to get results even with small amounts of tissue. These capabilities should allow laboratories to eliminate macro-dissection of tumor blocks, potentially resulting in major workflow improvements and cost savings.
Target Selector assays can be used in combination with a variety of low-cost analytical platforms including qPCR, Sanger sequencing, microarrays, and mass-spectrometry, in addition to next generation sequencing. Target Selector kits (RUO and CE-IVD) offer high content per assay, which can reduce costs by selectively amplifying multiple mutations/variants in hot-spot regions of interest in a single reaction. All Target Selector assays are quantitative.
Target Selector molecular assay kits (RUO and CE-IVD) are currently available for EGFR and BRAF mutations. Additional test kits for other oncogene mutations are planned for launch in the future. For more information on Biocept’s Target Selector molecular assay kits, contact Biocept Customer Service at (888) 332-7729 or [email protected].