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Biodesix obtains CE mark clearance for VeriStrat specimen collection and shipping kit

US-based molecular diagnostics company Biodesix has received the CE Mark for its VeriStrat specimen collection and shipping kit, a blood-based protein diagnostic that predicts differential treatment outcomes for non-small cell lung cancer (NSCLC).

The VeriStrat test is designed for patients with advanced NSCLC to identify patients who are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors (EGFRs).

The non-invasive serum proteomic test predicts differential treatment outcomes between two types of therapies for second-line treatment of non-operable, advanced NSCLC: chemotherapy or the targeted drug erlotinib (Tarceva).

The VeriStrat test along with other clinical factors can help physician decide which treatment is right for their non-small cell lung cancer patients.

Currently, erlotinib, an EGFR inhibitor, is commonly used in NSCLC patients who harbor an EGFR mutation.

VeriStrat provides oncologists with information to help them select between erlotinib (Tarceva) and single-agent chemotherapy for advanced NSCLC patients.

The multi-center, randomized proteomic stratified study (known as PROSE) is the first completed prospective biomarker-stratified validation study in oncology.

The study of 285 patients confirmed that VeriStrat status is prognostic and specifically predictive of differential overall survival benefit for erlotinib versus chemotherapy in the second-line setting.

The study results showed no significant difference between patients classified as ‘VeriStrat Good’ and ‘VeriStrat Poor’.

Biodesix CEO David Brunel said making VeriStrat results available to physicians for patients in the European Union has been an important goal for 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," Brunel added.

"VeriStrat will allow them to make targeted, timely treatment decisions that can improve survival outcomes and potentially provide a higher quality of life."