Affymetrix, Inc. (NASDAQ:AFFX) and Signature Diagnostics AG (Signature Dx) today announced that they have signed a Powered by Affymetrix™ (PbA) agreement. Under the agreement, Signature Dx obtains a worldwide license to use Affymetrix® microarray technology to develop and commercialize diagnostic and prognostic colorectal cancer (CRC) tests.
“Colorectal cancer is one of the most common cancers worldwide and our innovative, multivariate IVD tests can significantly improve both the diagnosis and prognosis of the disease”
Signature Dx plans to launch two microarray-based in vitro diagnostic (IVD) products by the fourth quarter of this year to enable earlier diagnosis and improved prognosis for CRC. Approximately 396,000 people are diagnosed with CRC annually in the five major European countries and the US, and millions more go undetected because of limitations in current diagnosis methods. Signature Dx will launch the tests in Europe and plans to seek US regulatory approval in the future.
Detector C is a validated, non-invasive, blood-based early detection test that has shown consistently high sensitivity of 90 percent for all four CRC stages (including early stages), and a specificity of 88 percent. Predictor C is a validated prognostic tissue test that predicts disease progression in stage II and III CRC patients and been shown to identify half of all stage II/III patients with a high risk of disease progression.
"Colorectal cancer is one of the most common cancers worldwide and our innovative, multivariate IVD tests can significantly improve both the diagnosis and prognosis of the disease," said André Rosenthal, PhD, Chief Executive Officer of Signature Diagnostics. "Our novel Detector C blood screening product together with Affymetrix' gene expression array technology brings CRC screening to a new level of accuracy and sensitivity. This licensing agreement provides us with the underlying microarray technology for our diagnostic products in colorectal cancer."
"Signature Diagnostics' innovative colorectal cancer tests have the potential to vastly improve diagnosis and lead to better-informed treatment decisions for this disease," said Andrew Last, PhD, Executive Vice President and Chief Commercial Officer at Affymetrix. "This Powered by Affymetrix agreement demonstrates the importance of microarray technology in advancing healthcare and further reinforces Affymetrix' leadership position in the global shift towards personalized healthcare."
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