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New York State Approves Quest's ColoVantage Test

By a GenomeWeb Staff Reporter

NEW YORK (GenomeWeb News) – Quest Diagnostics today announced the New York State Department of Health has approved its ColoVantage colorectal cancer test for use in the state, making it available in all 50 states.

Quest added that it believes ColoVantage is the first molecular colorectal cancer detection method employing venal blood specimen to be approved by the state.

The test detects methylated DNA of the Septin-9 gene from a patient's blood sample. Quest licensed the biomarker from German firm Epigenomics in 2008 and launched ColoVantage in December 2009.

Quest said that in a clinical validation study, ColoVantage identified colorectal cancer in 70 percent of samples from people diagnosed with colorectal cancer, and correctly detected the absence of cancer in about 89 percent of samples.

The test is targeted at patients who should get screened for the cancer but are reluctant to do so. According to the American Cancer Society, men and women at average risk for the cancer should be screened beginning at age 50. However, only half of this population is up to date on screening, partly because other methods, such as colonscopy, flexible sigmoidoscopy, and fecal occult blood tests, are invasive or unpleasant, Quest said.

"ColoVantage is a convenient, noninvasive option for the millions of patients 50 years of age and older who resist testing by recommended screening methods," said Jon Cohen, senior vice president and chief medical officer for Quest in a statement. "As a technique that patients may actually use, ColoVantage is arguably the first practical testing option to promote meaningful cancer evaluation among this large underserved population."

The test cannot replace colonoscopy and is not validated as a general screening test, Jay Wohlgemuth, vice president of science and innovation for Quest, said, "[b]ut the test's ability to detect this cancer may persuade non-adherent screening-eligible individuals who receive a positive result to undergo colonoscopy or other evaluation."

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