Biodesix receives CE Mark for diagnostic kit

BOULDER – Biotech research company Biodesix Inc. on Wednesday announced that its VeriStrat specimen collection kit has obtained the CE Mark, paving the way for the company to make VeriStrat results available to doctors in the European Union and other countries that recognize the CE Mark.

VeriStrat is a noninvasive diagnostic test that predicts whether patients with non-operable, advanced non-small cell lung cancer would be better served by chemotherapy or the drug erlotinib.

The VeriStrat results are used along with other factors to guide treatment decisions.

VeriStrat, according to a Biodesix press release, will help doctors consider ruling out the roughly 30 percent of NSCLC patients who are unlikely to benefit from erlotinib and should receive chemotherapy.

“Making VeriStrat results available to physicians for patients in the European Union has been an important goal for Biodesix,´ said David Brunel, chief executive of Biodesix. “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. VeriStrat will allow them to make targeted, timely treatment decisions that can improve survival outcomes and potentially provide a higher quality of life.”