The San Diego-based company announced Monday the availability of research-use-only (RUO) Target Selector kits that will allow molecular laboratories globally to 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.
Biocept's Target Selector platform is patent protected in the US, in seven countries in Europe and in five additional international territories. The first available kits validated for both tissue and blood are for the detection of EGFR mutations, which are among the most frequently evaluated biomarkers for lung cancer.
The company said additional RUO test kits for other oncogene mutations are planned for launch in the future.
Biocept's Target Selector platform utilizes patented Switch-Blocker technology to enrich the specimen for mutations of interest, resulting in ultra-high assay sensitivity and specificity compared to methods currently used in most laboratories.
"The launch of FFPE capabilities represents a major opportunity for our Target Selector kits, given the significant market for tissue testing for mutations in solid tumors and the rapid growth in the liquid biopsy segment," said Biocept CEO Michael Nall in a statement.
"Our new dual sample kit offers researchers and assay developers efficiencies and cost savings, including the ability to validate one assay platform for both tissue and blood, and the ability to eliminate the need for macro-dissection for FFPE samples.”
Nall said: “In addition, with FFPE samples, QNS (quantity not sufficient) can prevent labs from obtaining biomarker results. Based on the assay's ability to work with extremely low tumor input and small tissue samples, Target Selector may provide a result when other FFPE assays are unable to do so."
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