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Biodesix Obtains US Patent for Protein Biomarker-Based VeriStrat Lung Cancer Test


This story originally ran on June 22 and has been updated to clarify comments made by Hedrick regarding the FDA's IVDMIA guidelines.

By Adam Bonislawski

Molecular diagnostics firm Biodesix announced this week that it has received a US patent for its VeriStat protein biomarker-based lung cancer serum test.

The patent covers use of the test, which employs a panel of eight proteins and peptide fragments to identify patients likely to benefit from epidermal growth factor targeted therapy, as well as mass spectrometry processes, algorithms, and other aspects of Biodesix's ProTS biomarker discovery technology.

Biodesix launched VeriStat commercially in May 2009, offering it out of its CLIA-accredited laboratory. Aimed at second-line lung cancer patients, the test has a potential market of 60,000 patients, Jennifer Hedrick, senior director of marketing at Biodesix, told ProteoMonitor.

According to Hedrick, sales of the test in the first half of 2010 are on pace to be up 12 percent over the second half of 2009, although she declined to give the total number of tests the company has sold since launching last year.

Biodesix is also looking to apply the VeriStrat test to diseases beyond lung cancer, Hedrick said.

"We have data right now that's been published on colorectal cancer, head and neck cancer, and we intend to look into pancreatic cancer," she said. "There are no specific timelines for getting those indications out, but that's what we're working towards."

The company also plans to develop the test for IVD use but will wait until the US Food and Drug Administration has provided clearer guidelines for the process, Hedrick said.

"Our intention is eventually to work with the FDA once we know what the guidelines are going to be," she said.

Hedrick noted that the agency issued a draft guidance on in vitro multivariate diagnostics -- complex lab-developed multiplex tests that rely on mathematical algorithms to interpret multiple biomarkers -- in 2007, but has not yet finalized it.

"FDA keeps saying it's going to be a priority, but we've yet to see anything really come out of it," she said.

The company has not yet approached the FDA for approval and currently operates under CLIA guidelines.

"As soon as FDA does come out with regulatory framework for IVDMIAs, then we intend to comply fully," she said.

As ProteoMonitor sister publication Pharmacogenomics Reporter reported last week, the FDA announced that it was postponing its plans to issue a final guidance on IVDMIAs in order to focus more broadly on the regulation of all laboratory-based tests (PGx Reporter 6/17/10).