NEW YORK – Biocept said on Tuesday that it has been awarded the CE-IVD mark for its Target Selector EGFR mutation detection assay, allowing the company to commercialize the kits throughout the European Union and other CE mark geographies.
Biocept's Target Selector technology is designed to support individual mutation assays targeting key oncogene mutations. It uses a patented "switch-blocker" method to enrich a specimen for mutations of interest, increasing sensitivity and specificity.
The company launched its first research-use-only kits — for both formalin-fixed paraffin-embedded tissue and circulating tumor DNA — earlier this month.
According to the firm, the assay kit is designed to test for highly informative EGFR mutations, including those necessary for making treatment decisions such as Del19, L858R, and T790M. Moving forward, Biocept plans to submit additional biomarker Target Selector molecular assay kits for CE marking.
"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," Biocept President and CEO Michael Nall said in a statement.
"Previously we announced CE-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.