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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Mar 17, 2011

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Quest Diagnostics said this week that its ColoVantage test has been approved by New York State's Department of Health for testing on samples of patients in the state.

ColoVantage is designed to aid in the detection of colorectal cancer in patients who resist testing by guideline-recommended screening methods. The test detects methylated DNA of the Septin9 gene from a specimen of blood taken from a patient's arm.

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

Quest introduced ColoVantage in December 2009. New York is the only US state with an independent regulatory review process for laboratory developed tests, which are also regulated at the federal level. With the approval, Quest can now offer the test in all 50 US states.

The methylated Septin9 biomarker was licensed to Quest by Epigenomics in 2008.


DNA Genotek said this week that it has filed for US Food and Drug Administration clearance of its Oragene Dx family of products.

The Oragene products are used to collect DNA samples from saliva and to isolate and stabilize DNA for transport and storage.

"We believe that the successful completion of this 510(k) clearance will facilitate broad use of Oragene Dx in molecular diagnostics," DNA Genotek President and CEO Ian Curry said in a statement.

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