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Arrayit Hires Docro to Smooth FDA Path for OvaDx Test


By Justin Petrone

Arrayit will work with contract research organization Docro to help it prepare its first diagnostic assay for submission to the US Food and Drug Administration, the company said this week.

Arrayit is hoping to submit OvaDx, an array-based pre-symptomatic ovarian cancer test that includes 100 proteomic biomarkers, to the FDA later this year. The Sunnyvale, Calif.-based firm said that the test can detect both early- and late-stage ovarian cancer. In December 2009, Arrayit obtained an exclusive license to use ovarian cancer biomarkers identified at Wayne State University (see BAN 12/15/2009).

Seymour, Conn.-based Docro assists firms with clinical trials of in vitro diagnostics and has aided firms in gaining 39 pre-market approvals and 46 510(k) applications, according to ArrayIt. It also noted that Docro has a 99 percent success rate with the FDA.

"Docro brings a breadth and depth of experience that matches the importance of bringing the first early stage pre-symptomatic ovarian cancer screening test to market," Arrayit CEO Rene Schena said in a statement.

OvaDx will be marketed and sold by the company's subsidiary Arrayit Diagnostics, which is based in Houston and was founded last year (see BAN 8/18/2009).

Arrayit is involved several collaborations that could lead to future tests. In April 2009, the firm announced a partnership with researchers in the neurodegenerative division of the Parkinson's Institute and Clinical Center, also located in Sunnyvale. The institute researchers will use Arrayit's Human Genome H25K array to look for biomarkers linked to Parkinson's disease (see BAN 4/14/2009).

Financial terms of the agreement between Arrayit and Docro were not discussed.

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