N.Y. Department of Health Approves Colon Cancer Test

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MADISON, N.J.—Quest Diagnostics Incorporated, a cancer diagnostics company, recently announced that its ColoVantage test has been approved by New York State's Department of Health for testing on samples of patients in the state. It is believed to be the first molecular colorectal cancer detection method that employs a venal blood specimen to be approved by the state. 

"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 R. Cohen, MD, senior vice president and chief medical officer, Quest Diagnostics. "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. It is fitting that March, colorectal cancer awareness month, marks the date our test met New York's rigorous regulatory criteria."

Men and women at average risk for colorectal cancer should be screened beginning at age 50, according to the American Cancer Society, but only about half of this population nationally is up-to-date on screening. Some patients regard recommended tests, such as colonoscopy, flexible sigmoidoscopy and fecal occult blood tests (FOBTs), as invasive or unpleasant, and refuse or delay testing.

ColoVantage is designed to aid in the detection of colorectal cancer in patients who resist testing by guideline-recommended screening methods. Unlike other colorectal cancer tests, ColoVantage does not require dietary restrictions or special preparations and testing can be added to routine blood work. As with any noncolonoscopy test, a positive test result should be followed up by colonoscopy.

The test detects methylated DNA of the Septin9 gene from a specimen of blood taken from a patient's arm. The Septin9 biomarker has shown consistently high performance in colorectal cancer detection in several case-control studies. The biomarker was licensed to Quest Diagnostics by its owner Epigenomics AG a cancer molecular diagnostics company, in 2008.

In a clinical validation study, ColoVantage correctly identified colorectal cancer in 70 percent of samples of people diagnosed with the cancer. It also correctly detected the absence of colorectal cancer in about 89 percent of samples tested.

"ColoVantage cannot replace colonoscopy, and it has yet to be validated for colon cancer screening," said Jay G. Wohlgemuth, MD, vice president, science and innovation, Quest Diagnostics. "But the test's ability to detect this cancer may persuade nonadherent screening-eligible individuals who receive a positive result to undergo colonoscopy or other evaluation."

Quest Diagnostics was the first laboratory in the United States to offer a molecular test employing blood taken from a patient's arm for aiding in the detection of colorectal cancer when it released ColoVantage in December 2009. New York is the only U.S. state with an independent regulatory review process for laboratory developed tests, which are also regulated at the federal level. With the approval, Quest Diagnostics can offer ColoVantage in New York as well as in all other U.S. states.

Colorectal cancer is the third most common cancer in men and women in the U.S., with more than 51,000 deaths expected this year, according to estimates from ACS.

Source: Quest Diagnostics

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