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Biodesix Gets CLIA Certification from New York, Making Veristrat Available in All 50 States


Molecular diagnostics firm Biodesix said this week that it has received CLIA certification from New York, making the company's Veristrat test available in all 50 states.

Veristrat, a protein biomarker-based companion diagnostic for non-small cell lung cancer, launched commercially in May 2009. In November 2010, Biodesix raised $7.1 million in a Series C funding round to finance ongoing commercialization efforts for the test, including examining its utility with new drug combinations (PM 11/12/2010).

While the company has thus far offered the diagnostic exclusively out of its CLIA-accredited laboratory, it also plans to develop the test for IVD use, Jennifer Hedrick, the company's senior director of marketing, told ProteoMonitor in June 2010. It plans to wait, however, until the US Food and Drug Administration has provided clearer guidelines for the IVD approval process, she said (PM 6/25/2010).

The agency has said it will release a guidance covering laboratory-developed tests like Veristrat sometime this spring.

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