Target Selector™ assay kits enable assay developers to leverage Biocept’s patented, high-sensitivity technology for the detection of key actional oncogene mutations from both tissue biopsies and blood for liquid biopsy uses
SAN DIEGO, April 28, 2020 /PRNewswire/ --Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, announces the award of CE (Conformité Européene)-IVD Mark for its Target Selector™ molecular assay EGFR Kit. The CE Mark confirms that the Company's Target Selector™ kit products meet the requirements of the European In-Vitro Diagnostic Devices Directive (98/79/EC) and allows Biocept to commercialize its kits throughout the European Union and other CE Mark geographies. Biocept's Target Selector™ molecular assay kits detect key oncogene mutations through the analysis of both Formalin-Fixed Paraffin-Embedded (FFPE) tissue gained from surgical biopsies as well as circulating tumor DNA (ctDNA) gained from blood-based liquid biopsies. The EGFR pathway can include mutations that are among the most frequently evaluated biomarkers for lung cancer. The Biocept assay kit is designed to test for highly informative EGFR mutations, including those necessary for treatment decisions such as Del19, L858R and T790M. Biocept's future plans include submission of additional biomarker Target Selector™ molecular assay kits for CE-IVD Mark. Biocept's Target Selector™ ctDNA platform also utilizes the Company's patented Switch-Blocker technology which enriches the specimen for mutations of interest, resulting in ultra-high assay sensitivity and specificity compared to other methods currently used in other laboratories. Biocept's Target Selector™ assay technology is patent protected in the United States, seven countries in Europe and five international territories. "Obtaining the CE-IVD Mark expands the market opportunity for our Target Selector™ molecular assay kits in the EU and other major international markets where we are seeing an acceleration in adoption of liquid biopsy-based testing," said Michael Nall, President and CEO of Biocept. "We believe our Target Selector™ molecular assay kits offer features that uniquely meet the needs of the EU and other international markets through the highly sensitive detection of key actional mutations and while being extremely cost effective. "Previously we announced CEE-IVD mark for our CEE-Sure™ ambient temperature blood collection tube and ship kit. We are excited to now offer laboratories in the EU and other international markets a complete solution from sample acquisition to shipping and on through molecular assay reporting for tissue or liquid biopsy-based testing," he added. About Biocept's Target Selector™ Molecular Assay Kits Biocept's Target Selector™ molecular assay kits can enable molecular laboratories around the world to detect key oncogene mutations through the analysis of both Formalin-Fixed Paraffin-Embedded (FFPE) tissue gained from surgical biopsies as well as ctDNA gained from blood-based liquid biopsies. Target Selector™ molecular assay kits utilize Biocept's proprietary and patented Switch-Blocker technology to enable industry-leading sensitivity for the detection of mutations/variants of interest in ctDNA (one mutant copy in 10,000 wildtype DNA). Due to its industry-leading sensitivity and the ability to block DNA amplification from normal cells, we believe Target Selector™ should allow laboratories to eliminate macro-dissection of tumor blocks, which can result in major workflow improvements and cost savings in the pathology laboratory. Target Selector™ assays can also provide results with small DNA inputs compared to most tissue-based assays, thus allowing the laboratory to get results even with small amounts of tissue. The 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 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. For more information on Biocept's Target Selector™ liquid biopsy kits, or to order Assay Kits, please contact Biocept Customer Service at (888) 332-7729 or go to customerservice@biocept.com. About Biocept Forward-Looking Statements Disclaimer Statement Investor Contact:
SOURCE Biocept, Inc. |
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Company Codes: NASDAQ-SMALL:BIOC |