Biodesix, a Boulder, CO-based company that develops molecular diagnostic tests, said today that it has passed a key clinical trial that shows its VeriStrat test can give physicians a better idea of what to do next after the first round of treatment for non-small cell lung cancer has failed.
The result of the trial, from the third and final phase of clinical studies normally required for FDA approval of a new diagnostic, is a milestone for Biodesix, CEO David Brunel said. The company develops blood tests that identify proteins that indicate what type of tumor a patient has, so the physician can design a treatment plan more likely to work for the individual patient. VeriStrat is the first test the company has developed and commercialized.
The trial, which enrolled 285 patients, shows that oncologists can use VeriStrat to determine how they should treat patients after first-line therapy, typically chemotherapy, has failed, Brunel said. Specifically, VeriStrat can tell oncologists whether they should progress to a second type of chemotherapy or prescribe the targeted oral medication erlotinib (Tarceva). VeriStrat does so by identifying patients unlikely to respond to erlotinib, which is marketed by Roche/Genentech. Since the targeted drug is expensive, comes with side effects like rash, and doesn’t work for every patient, Biodesix reasons that a better diagnostic could greatly help patients and physicians decide whether to take it.