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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.

The Scan

Comfort of Home

The Guardian reports that AstraZeneca is to run more clinical trials from people's homes with the aim of increasing participant diversity.

Keep Under Control

Genetic technologies are among the tools suggested to manage invasive species and feral animals in Australia, Newsweek says.

Just Make It

The New York Times writes that there is increased interest in applying gene synthesis to even more applications.

Nucleic Acids Research Papers on OncoDB, mBodyMap, Genomicus

In Nucleic Acids Research this week: database to analyze large cancer datasets, human body microbe database, and more.