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Warnex Licenses Epigenomics' Septin9 Marker; Will Offer Colorectal Cancer Dx in Canada

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German molecular diagnostics company Epigenomics said this week that it has granted to Warnex Medical Laboratories a non-exclusive license for Epigenomics' colorectal cancer biomarker Septin9.

Under the terms of the agreement, Warnex, based in Laval, Quebec, has the rights to establish a PCR-based laboratory-developed test for Septin9 and offer colorectal cancer blood testing services in Canada. Warnex said that it plans to launch the testing service in the next few months.

As the first laboratory to offer Septin9 testing in Canada, Warnex, subject to certain conditions, will receive a time-limited head-start period of exclusivity for the Canadian market, though the companies did not disclose the length of this period.

Epigenomics also said that it will be entitled to certain undisclosed royalty payments under the agreement. Further financial details were not disclosed.

Epigenomics, based in Berlin, has demonstrated in studies with more than 3,300 blood samples that methylated DNA of the Septin9 gene in blood plasma is a reliable indicator of colorectal cancer of all stages and all locations.

The biomarker is the basis for Epigenomics' non-invasive colorectal cancer early detection test, called Epi proColon, which the company launched in October. The test, originally designed to be run on Roche's LightCycler 480, received a CE mark for in vitro diagnostics in Europe, making it the first ever IVD blood test for early detection of colorectal cancer to be offered there.

In December, Epigenomics also signed on Abbott as a strategic partner to develop and market a similar blood test in European and Asian/Pacific markets. Abbott now sells the test as the RealTime mS9 Colorectal Cancer Assay to be run on its RealTime system m2000.

Epigenomics also licenses Septin9 to Quest Diagnostics, which in January began offering a laboratory-developed blood test in the US to help physicians detect colorectal cancer. The test is not yet approved for use by the US Food and Drug Administration.

Finally, last month, Epigenomics inked a deal with another strategic partner, European clinical lab network Synlab, which has started offering Epi proColon through 55 German sites in its network on top of the 17 clinical labs in Germany and Switzerland that already offered the test. This deal came on the heels of a €33.1 million ($44.2 million) combined private and public share offering by Epigenomics (PCR Insider, 4/8/2010).

Epigenomics' deal with Warnex further expands the availability of its Septin9-based test in North America.

"We are pleased to add this colorectal cancer test based on real-time PCR technology to our service offering as part of our continued commitment to offering the most advanced specialized diagnostic services to Canadian healthcare professionals," Mark Busgang, president and CEO of Warnex, said in a statement. "This blood test … offers an easy and accurate method to help diagnose patients with colorectal cancer."

Epigenomics CEO Geert Nygaard said in a statement that Warnex is "the ideal partner to make colorectal cancer blood testing based on our Septin9 biomarker in Canada. This agreement is an important further step in the international rollout of Septin9 testing, which is already commercially available in the US and Europe."

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