Signature Diagnostics plans to debut a pair of microarray-based colorectal cancer diagnostics in Europe by the fourth quarter, and said it plans to seek US regulatory approval "in the future."
The multivariate tests, which will be based on Affymetrix's array platform, are called Detector C and Predictor C. The former evaluate the expression of 202 genes that are altered in response to tumor formation and growth and has a 90-percent sensitivity and 88-percent specificity for all four colorectal cancer stages. The latter evaluate the expression of 32 genes that are involved in the disease's progression and will be used to identify disease progression in patients with stage II and III colorectal cancer.
As I reported earlier this month, Signature CEO André Rosenthal said the test is "particularly well suited for population screening” and 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.
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.