Biodesix this week received an EU CE Mark for its Veristrat specimen collection and shipping kit, allowing the company to make Veristrat results available to physicians in the EU and other countries recognizing the CE Mark.
Veristrat is a blood-based proteomic diagnostic that identifies non-small cell lung cancer patients likely to respond to chemotherapy or the EGFR inhibitor Tarceva (erlotinib). Biodesix launched sales of the test in the US out of its CLIA lab in 2009 and has since performed more than 5,000 tests.
“Making VeriStrat results available to physicians for patients in the European Union has been an important goal for Biodesix,” Biodesix CEO David Brunel said in a statement. "With the CE Mark for the specimen collection and shipping kit, more physicians can incorporate this valuable new component into the set of tools they need to guide therapy."