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Biodesix Publishes Study Indicating Significant Influence of Veristrat on Doctor Treatment Decisions

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Researchers affiliated with Biodesix have completed a study indicating that the company's Veristrat test for identifying non-small cell lung cancer patients likely to respond to tyrosine kinase inhibitor treatment plays a significant role in guiding physician decisions.

In the study, detailed in a paper published this week in Current Medical Research & Opinion, a team led by John Hornberger, adjunct clinical professor of medicine at Stanford University School of Medicine, found that roughly 40 percent of surveyed physicians reported changing their patient treatment plans based on the results of the Veristrat test.

Funded by Biodesix, the work serves to demonstrate the utility of the Veristrat test and that physicians act on that utility, company CEO and director David Brunel told ProteoMonitor.

He noted that the results could prove key to the company's ongoing push to obtain payor coverage for the test and to efforts to obtain Medicare coverage in particular.

Research like the CMRO study "has been indicated as an important milestone by the [Centers for Medicare and Medicaid] contractors as part of their process for determining coverage and payment," Brunel said. He declined to provide a timeline for when the company hopes to receive a decision about Medicare coverage, but said that he believes the firm is close to a ruling.

VeriStrat is a proteomic test based on Biodesix's ProTS mass spec platform. The test combines MALDI mass spectrometry with a set of algorithms to predict response to EFGR TKI therapy based on a patient's proteomic profile. The company released the test commercially in May 2009 and offers it out of its CLIA-accredited laboratory.

Since the launch, Biodesix has sold roughly 5,000 Veristrat tests. Its sales efforts have been limited, however, by the need to obtain reimbursement for the test, Brunel said.

He said that the firm has seen "pretty dramatic" sales growth for the test since its launch. "However, our commercial effort has been restrained by this process of getting reimbursement. Because of that we did not anticipate significant growth because we were not making the incremental investments in our commercial infrastructure," he said.

In addition to the research published this week, Biodesix is working on several other studies aimed at bolstering its case for the test with payors, Brunel said, including work that will assess its economic impact on the overall lung cancer treatment process.

In the CMRO study, the researchers surveyed 710 physicians treating NSCLC patients who ordered 2,822 Veristrat tests over a period stretching from August 2011 to November 2012. They asked for their treatment recommendations both before and after receiving the results of the Veristrat test to determine how the test results affected their decisions regarding whether or not to treat patients with the TKI erlotinib, marketed by Genentech and Roche as Tarceva. The study did not examine how these changes in treatment decisions affected patient outcomes.

The researchers received responses from 226 physicians who provided pre- and post-test treatment information on 403 tests. In roughly 90 percent of the cases, the surveyed doctors followed the course of treatment recommended by the Veristrat results, and in 40 percent of the cases they changed their initial treatment recommendations based upon the results of the test.

Among patients whose doctors were pre-test considering erlotinib treatment only, 95.5 percent who received a Veristrat "good" rating – indicating that they would likely be TKI responders – ultimately received erlotinib treatment, demonstrating that the "good" score largely reinforced the physician's initial judgment.

Among patients who received a Veristrat "poor" rating– indicating that they would likely not respond to TKI treatment – only 13.3 percent received erlotinib, meaning that in 86.7 percent of these cases the physicians changed their recommendations based on the Veristrat test results.

In patients whose doctors were pre-test considering several therapies including erlotinib, 83.6 percent who scored Veristrat "good" received erlotinib, while only 4.3 percent who scored "poor" received the drug.

And among patients whose doctors were not considering erlotinib pre-test, none who scored Veristrat "poor" received the therapy, while 73.5 percent of those who scored "good" ended up receiving erlotinib – demonstrating a significant shift in physician treatment strategy based on the test results.

Stanford's Hornberger told ProteoMonitor that the 40 percent of cases identified by the study in which doctors changed their treatment decision based on the test was "on the higher side of what is usually published" in such studies. However, he noted that "there is no single, optimal cutpoint for level of change in decisions, as this is context dependent."

"Some tests may be a good value if they change just 10 percent of decisions, and others may need to change more than 40 percent of decisions to be a good value," he said, noting that determining the overall value of the test for patients and payors would require "subsequent comprehensive analyses of the outcomes, economics, and ethics of test adoption."

He also cautioned that "early clinical utility studies of novel molecular technologies tend to show higher rates of change in decisions than subsequent studies." This, he noted, was likely due to the fact that physicians participating in such early studies are often "early adopters" who may be more likely on average to follow the test's recommendations.

"Other factors that likely play a role include whether the test is ordered by physicians in a community setting versus academic setting, the amount of evidence supporting clinical validity, endorsement of the test by professional guidelines, and quality of other tests used to guide decision making," Hornberger said.

While the CMRO study focused on Veristrat for guiding use of erlotinib in NSCLC, Biodesix has studied use of the test with a variety of TKIs including bevacizumab – marketed by Roche as Avastin (PM 4/27/2012) – and Kadmon's KD019 agent (PM 3/2/2012). The company has also used the test in breast cancer studies investigating the Novartis aromatase inhibitor Femara (PM 12/16/2011) and in a pancreatic cancer study looking at GlobeImmune's GI-4000 biologic therapy (PM 6/29/2012).

In all, the company is currently involved in 14 collaborations with pharmaceutical firms, Brunel said.

Brunel said the company has had discussions with the US Food and Drug Administration about taking the test through the agency's approval process, but it plans to stick with the laboratory-developed test model for the foreseeable future.

This model, he said, is particularly well suited to Veristrat given that the test runs on the company's proprietary mass spec-based platform, which precludes Biodesix from packaging it and selling it as a kit.

Brunel did note, however, that if one of the company's pharma collaborators decided they wanted to market the test as a companion diagnostic to one of their drugs, Biodesix would have to take the test through the FDA.

He added that the company saw that as "a distinct possibility over the course of the next 12 to 24 months."

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