Biocept Inc (NASDAQ:BIOC), a commercial developer of liquid biopsy tests, announced Tuesday that its Target Selector molecular assay EGFR kit has earned a CE-IVD (in-vitro diagnostic) mark from European regulators.
The designation allows Biocept to sell its kits throughout the European Union and other CE mark geographies. The kits are able to detect key oncogene mutations by analyzing tissue taken through surgical biopsies and circulating tumor DNA (ctDNA) gained from blood-based liquid biopsies.
Mutations in what’s known as the EGFR pathway are frequent biomarkers for lung cancer, and identifying them can help guide treatment decisions, the company said.
READ: Biocept expanding uses for its Target Selector liquid biopsy technology to detect cancer biomarkers
"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 CEO Michael Nall said in a statement.
"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.”
The Target Selector ctDNA platform also relies on Biocept’s patented Switch-Blocker technology, which enriches specimens for mutations of interest, resulting in ultra-high sensitivity and specificity compared to other methods, the company noted. The technology is patent protected in the US, seven European countries and five international territories.
In November, the company’s CEE-Sure Blood Collection Tube and CEE-Sure Sample Collection Shipping Kits also became available in Europe.
"Previously we announced CEE-IVD mark for our CEE-Sure ambient temperature blood collection tube and ship kit,” Nall said. “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.”
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