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FDA Warns Exact Sciences that CRC Assay Requires Premarket Approval

NEW YORK (GenomeWeb News) - Exact Sciences said yesterday that it has received a warning letter from the US Food and Drug Administration notifying the company that its colorectal cancer screening assay will require premarket approval.
 
In the letter, the FDA's Office of In Vitro Diagnostics Device Evaluation and Safety said it believes the company’s DNA-based PreGen-Plus assay is a medical device and therefore requires premarket approval or clearance.
 
Company president Jeffrey Luber said in a statement that Exact has discussed the letter with the FDA, and that it is "committed to working collaboratively” with the agency to pursue the appropriate filing strategy for the test.
 
Luber said the firm has a meeting scheduled with the FDA in the “coming weeks” and that it plans to file a 510(k) application “as soon as possible to resolve these issues.”
 
He added that "a potential regulatory filing for our patent-protected technology had already been a long-term strategy for Exact and we will now be accelerating these activities."
 
Exact has an existing agreement with Laboratory Corporation of America to distribute the PreGen-Plus colorectal cancer screening test. The companies expanded the deal in June to give LabCorp rights to exclusively license the test through 2010. 

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