Signature Dx to Launch Colorectal Cancer IVD in Late-'10, Early-'11

By Kirell Lakhman

German test maker Signature Diagnostics plans to launch its blood-based colorectal cancer screening IVD by the end of the year or in early 2011.

The company made the announced during a presentation at the ASCO conference yesterday, where it release positive data from a prospective multicenter validation study.

The assay, called Detector C, uses Affymetrix gene-expression chips to evaluate 202 genes known to be active in leukocytes in the presence of colorectal tumor formation.

In its ASCO presentation, Signature said the assay has 90-percent sensitivity for all four colorectal cancer stages and 88-percent specificity. It also claims to have found only one false negative in 872 tested.

The test is "particularly well suited for population screening,” Signature CEO André Rosenthal said in a statement, adding that its low number of false negatives "warrants its use prior to colonoscopy and as an alternative to inaccurate Hemoccult II tests.”

Other impending newcomers to the colorectal cancer-screening market include GeneNews, which in May said it plans to debut its ColonSentry assay in New York and New Jersey in the second half of 2010.

The company, based in Toronto, has been selling the RNA-based test in Ontario since 2008, and it is negotiating with potential partners to market the test in other regions of the US, Europe, and Asia.

But Signature and GeneNews will both have to deal in the colorectal cancer-screening market with Quest, which began selling its blood-based ColoVantage DNA methylation assay since January.

LabCorp also sells a pair of molecular colorectal tests, one that detects DNA in stool and another that detects microsatellite instability.

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