Biodesix Receives CE Mark for VeriStrat Collection and Shipping Kit

Boulder, Colo., devicemaker Biodesix says it has received the European CE mark for its VeriStrat specimen collection and shipping kit.

The noninvasive kit uses mass spectrometry to test blood for a protein that can predict differential outcomes between second-line treatment with Tarceva (erlotinib) or chemotherapy for patients with nonoperable, advanced non-small cell lung cancer.  Patients who test “VeriStrat Poor” will likely do better on chemotherapy, the devicemaker says, while those with a “VeriStrat Good” rating will receive greater benefit from Tarceva.

In a Phase III multicenter, randomized study of 285 patients, VeriStrat met the primary endpoint of overall survival, confirming that it is predictive of differential overall survival on either Tarceva or chemotherapy as a second-line treatment, Biodesix says.

The test relies on a simple blood draw, making it easy to use in oncology clinics, the company notes. The sample is then sent to a Biodesix CLIA-certified laboratory, which analyzes the results and returns results within 72 hours.

VeriStrat is also sold in the U.S. and was granted Medicare coverage in June of 2013. — Lena Freund

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