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Exact Sciences To Perform Clinical Study for CRC Assay, Expects to File 510(k) in 2009

NEW YORK (GenomeWeb News) – Exact Sciences said today that it is beginning a clinical study for its DNA-based colorectal cancer screening test that should take six to nine months, and that it plans to file for 510(k) approval for the test with the US Food and Drug Administration by the third quarter of 2009.
 
The company said today that it had completed discussions with the FDA regarding the clinical performance characteristics that will be required to validate its stool-based CRC assay and decided to “bolster the statistical power of the clinical study” by collecting “more clinical samples than the threshold that the FDA indicated would be acceptable.”
 
In October, the FDA warned the firm that the CRC assay is a medical device that requires premarket approval. The company has been in discussions with the agency regarding the test since that time.
 
Exact said that the clinical study could take up to nine months, which would enable a de novo 510(k) filing in the third quarter of 2009, and potential clearance of the test in the first quarter of 2010.
 
The prospective, multi-center study is expected to include around 30 participating sites in the US and Canada and will screen up to 5,000 asymptomatic individuals aged 50 or older who are at average risk for developing colorectal cancer. This study population is expected to yield a “minimum of 25 acceptable CRC cases,” Exact said.
 
The company said that the study will “exceed the FDA's minimum sensitivity performance threshold of a 95 percent confidence interval with a lower bound of 50 percent.”
 
Averion International, a clinical research organization, will manage the study.
 
The company said it expects the total study and regulatory costs to range from $6.5 million to $8.5 million. It added that its current cash and short-term investments will provide around $2 million through the end of 2008 to begin the validation studies.
 
In March, Exact said it was seeking “strategic alternatives,” which could include merging with or being bought by another company and that it had retained investment banking firm Leerink Swan to help it evaluate opportunities.

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