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.
The result of the trial was presented today at the annual meeting of the American Society of Clinical Oncology in Chicago. Vanesa Gregorc, of the department of oncology at the Scientific Institute of the University Hospital San Raffaele in Milan, Italy, was the principal investigator.
Brunel said the positive result could have a major impact on the success of VeriStrat and Biodesix. Biodesix has raised about $70 million, including another $8.8 million in mid-April. It employs about 75 people.
Prior tests that looked back retrospectively at samples from patients found that VeriStrat could identify which patients were likely to live longer if they took the targeted drug from Roche/Genentech. The study showed the test had promise but were not enough to make it a commonly used test, Brunel said.
“People were intrigued with our data,” Brunel said. But the key question was “did it make a difference how you treated the two groups?”
The results from the Phase 3 trial announced today, shows it can make that difference, in a prospective study, which means that patients got the Biodesix test, were treated based on its recommendation, and followed over time to see if they ended up any better off. Passing that kind of rigorous study, should greatly expands the commercial potential for VeriStrat, Brunel said.
“VeriStrat has been commercially available for several years, but adoption has been limited…. This could lead to widespread adoption,” Brunel said.
According to the American Cancer Society, about 220,000 Americans per year are diagnosed with lung cancer, and about 85-90 percent have non-small cell lung cancer.
Biodesix will now build a national sales team and develop its marketing to try to capitalize on VeriStrat’s commercial potential, which could improve as the federal government is expected to reach a decision soon about whether it will be covered by Medicare.
Commercial success will help Biodesix develop the other tests in its pipeline, vice president, business development and strategic marketing Paul Beresford said.
Other tests in the Biodesix pipeline could detect and determine treatment for various types of cancer or autoimmune disorders such as multiple sclerosis, he said.
Brunel said Biodesix is also working to show VeriStrat can be used to guide treatment for other forms of cancer, such as breast, ovarian, and pancreatic cancer.
On a higher level, Brunel said he believes Biodesix and similar companies developing molecular diagnostic technology are on the brink of a breakthrough. Researchers are getting much better at identifying protein biomarkers that would give doctors greater insight into how to treat patients.
Brunel says developing better diagnostic tools is the first step toward realizing the benefits promised by personalized medicine, and he believes products like VeriStrat and the results announced today shows companies can make the technology commercially viable.
In the near future, that could lead to molecular diagnostic companies being able to raise more money for research and development and clinical trials, he said.