OncoDefender
Everist Genomics’ CLIA Certification for High Complexity Clinical Testing
Everist Genomics received Clinical Laboratory Improvement Amendment (CLIA) certification for High Complexity testing in December 2010. Established by Congress in 1988, CLIA regulations specify standards for all non-research laboratory testing performed on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.
CLIA regulations are based on the complexity of the test method. The more complicated the test, the more stringent the requirements. By law, laboratories conducting High-Complexity testing are required to meet CLIA-specified quality standards, proficiency measures and undergo proficiency testing. Because the OncoDefender-CRC test has been classified by CLIA as a High-Complexity test, it is evaluated against the most stringent requirements, ensuring that Everist Genomics’ testing laboratory meets quality standards for accuracy, reliability and timeliness of patient results. It is significant, based upon these stringent requirements, that Everist Genomics’ laboratory remains today the only CLIA-certified laboratory to offer a molecular diagnostic test capable of accurately predicting the risk of recurrence of cancer in patients previously treated with surgical resection of a Stage I/II colon cancer tumor and Stage I rectal cancer tumor. In addition to maintaining compliance with CLIA requirements, the Everist Genomics laboratory is continuously evaluated through the company’s rigorous quality control protocols. |
March 7, 2011
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