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Biodesix Study Investigates Use of Veristrat with Novartis, GSK Breast Cancer Drugs

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This story originally ran on Dec. 13.

Biodesix last week presented results from a retrospective analysis of breast cancer patients using its serum proteomic Veristrat diagnostic.

According to the company, the results, which it presented at the 2011 San Antonio Breast Cancer Symposium, showed that Veristrat was able to identify patients with worse progression-free survival when treated with the Novartis aromatase inhibitor Femara.

The study represents Biodesix’s first effort to evaluate Veristrat for use “in breast cancer and the first with an endocrine agent,” CEO David Brunel said in a statement. The test is currently available as a laboratory-developed test for identifying advanced non-small cell lung cancer patients likely to benefit from treatment with epidermal growth factor inhibitors.

In the study, the company examined pretreatment serum samples from 1,041 patients enrolled in the Phase III trial EGF30008, which compared Femara plus placebo to Femara plus the GlaxoSmithKline tyrosine kinase inhibitor Tykerb in first-line, hormone receptor positive, advanced breast cancer patients. Patients in the Femara/placebo arm who tested Veristrat “Good” had a median PFS of 10.8 months compared to 2.8 months for patients who tested Veristrat “Poor.”

The test was less effective at distinguishing between patients in the Femara/Tykerb arm, with patients who tested Veristrat “Good” showing PFS of 11.4 months and patients who tested Veristrat “Poor” showing PFS of 11 months.

VeriStrat is based on Biodesix's ProTS platform, which 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 launched the test commercially in May 2009 and offers it out of its CLIA-accredited laboratory.

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