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Everist Genomics Laboratory Receives Approval From U.S. Regulatory Authorities For High Complexity Clinical Testing
Date:3/7/2011

ANN ARBOR, Mich. March 7, 2011 /PRNewswire/ -- Everist Genomics announced today that it has received U.S. Clinical Laboratory Improvement Amendment (CLIA) certification required for the company to launch its OncoDefender-CRC assay, a prognostic test for assessing the risk of cancer recurrence for patients with early stage colorectal cancer.  Because OncoDefender-CRC is categorized by CLIA as a high complexity test, it is evaluated against the most stringent federally-mandated requirements, ensuring that the company's testing laboratory meets quality standards for accuracy, reliability and timeliness of patient results.

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"Obtaining this regulatory certification represents a significant milestone in the company's commercial development path," said Prasad Sunkara, President and CEO of Everist Genomics. "Although Everist Genomics has always operated under rigorous scientific standards, it is encouraging to receive this type of regulatory validation from an independent authority. We expect that meeting the challenging certification guidelines enabling our clinical laboratory to perform high-complexity testing will give physicians and patients greater confidence when ordering the OncoDefender-CRC test."

OncoDefender-CRC, which measures the expression of colorectal cancer-specific genes, is the first and only molecular prognostic test capable of accurately predicting the risk of recurrence in patients previously treated with surgical resection of a Stage I/II colon cancer tumor or Stage I rectal cancer tumor. The company will officially launch the test later this month.

Everist Genomics released data from its external validation study of OncoDefender-CRC at the American Society of Clinical Oncology's 2011 Gastrointestinal Cancers Symposium in January. The study, which was conducted by Mayo Validation Support Services, indicated that the performance characteristics of the Onc
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