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Signature Dx to Launch Two Colorectal Tests on Affy Platform

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By Justin Petrone

German test developer Signature Diagnostics this week said it has obtained a worldwide license to use Affymetrix's GeneChip microarray platform to develop and commercialize its tests for colorectal cancer. The deal is part of Affy's 'Powered by Affymetrix' program.

Potsdam-based Signature Dx plans to launch by the fourth quarter of this year two array-based in vitro diagnostics for colorectal cancer. The company will first launch the tests in Europe and intends to seek US regulatory approval at an unspecified time in the future.

Signature Dx's tests are called Detector C and Predictor C. Detector C is a non-invasive, blood-based early detection test that evaluates the expression of 202 genes that are altered in response to tumor formation and growth. The test has demonstrated 90 percent sensitivity and 88 percent specificity for all four stages of colorectal cancer, according to the company. The Predictor C test evaluates the expression of 32 genes that predict disease progression in stage II and III colorectal cancer patients and has been shown to identify half of all stage II/III patients with a high risk of disease progression, the company said.

"Our novel Detector C blood screening product together with Affymetrix's gene expression array technology brings CRC screening to a new level of accuracy and sensitivity," André Rosenthal, CEO of Signature Diagnostics, said in a statement

Rosenthal did not reply to an e-mail seeking additional comment.

Financial terms of the agreement were not disclosed.

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