Ann Arbor's Everist Gets Federal OK For Cancer Test
Ann Arbor-based Everist Genomics said Monday that it had received United States Clinical Laboratory Improvement Amendment certification 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.
"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 or 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, conducted by Mayo Validation Support Services, indicated that the performance characteristics of the OncoDefender-CRC test are superior to other methods currently in use to predict recurrence.
Furthermore, studies demonstrate that high-risk OncoDefender-CRC results correlate with cohorts with higher risk of colorectal cancer recurrence within 3 years of surgery, while low-risk results correlate more closely with those patients without recurrence in 3 years.
OncoDefender-CRC examines expression levels of a panel of genes extracted from formalin-fixed paraffin-embedded cancer tissue taken at the time of surgery, and uses a proprietary computer-generated decision rule to accurately and reliably identify patients who are at risk of recurrence.
Everist Genomics is a prognostics company focused on developing gene-based molecular assays for the prediction of cancer recurrence and proprietary point-of-care equipment for the evaluation and management of cardiovascular disease.
Using its patented Evolver technology platform, Everist Genomics is successfully developing and commercializing entirely new classes of patent-protected molecular biomarkers and sensor technologies which employ proprietary equipment, devices and software to help physicians make individualized treatment and drug prescribing decisions. The privately owned company was founded in 2002.
More at www.everistgenomics.com.
