This story was originally published on April 7.
By Ben Butkus
German molecular diagnostics firm Epigenomics said this week that its flagship PCR-based blood test for colorectal cancer is now available through Synlab, one of the largest clinical laboratory networks in Europe.
In addition, PCR Insider has learned that Epigenomics recently raised approximately €33.1 million ($44.2 million) through a combined private and public share offering, which it will use for a variety of corporate purposes centered on expanding the market for its diagnostic tests and further developing tests in its product pipeline.
Under the distribution deal, Synlab has started offering Epi proColon, Epigenomics' blood-based test for early detection of colorectal cancer, through 55 German sites in its network. The deal significantly expands the availability of the test, which was already available from 17 clinical labs in Germany and Switzerland.
"We already had 15 labs in Germany and two networks in Switzerland on board, but now we have Synlab on board as an additional network," Achim Plum, vice president of corporate development for Epigenomics, told PCR Insider this week. "It's the third largest laboratory network in Europe, so it is a very significant player."
The Epi proColon test is based on the Septin9 gene, DNA from which is methylated in a vast majority of colon and rectal tumors, but not in normal cells. As tumor cells shed methylated Septin9 DNA into the bloodstream, the test can be used to detect and amplify it from patient plasma samples.
Epigenomics launched the test in October as a CE-marked in vitro diagnostic in Europe, making it the first ever IVD blood test for early detection of colorectal cancer to be offered on the continent. The test was originally designed to be run on Roche's LightCycler 480 instrument.
In December, Epigenomics also signed on Abbott as a strategic partner to develop and market a similar blood test based on Septin9 methylation in European and Asian/Pacific markets. As such, Epigenomics and Abbott optimized the test for Abbott’s RealTime system m2000, and it is now sold by Abbott as the RealTime mS9 Colorectal Cancer Assay.
In order to do the Synlab deal, Epigenomics also had to optimize its test for use on Life Technologies' Applied Biosystems 7500 Fast Real-Time PCR system, which Plum said is Synlab's testing platform of choice. "It was possible to sell through Synlab only by extending the test's instrument base," he said.
Epigenomics also licenses the Septin9 biomarker to Quest Diagnostics, which in January began offering a laboratory-developed blood test for aiding in the detection of colorectal cancer to physicians in the US. The test is not yet approved for use by the US Food and Drug Administration; however, Epigenomics is currently sponsoring a multi-center clinical study called Presept in collaboration with Quest and other organizations to evaluate the Septin9 test for detecting colorectal cancer in undiagnosed patients.
Epigenomics' deal with Synlab may also eventually expand the availability of Epi proColon throughout Europe. Synlab has laboratories in 16 European countries, as well as four countries in the Middle East, all of which could theoretically offer the test, collect patient samples, and send them to Oncoscreen, Synlab's central oncology laboratory in Jena, Germany.
However, Plum said that for the time being Synlab is focusing its marketing primarily on Germany as it looks to gain acceptance for the test. "We could eventually sell [the test] to sites outside Germany," Plum said. "At the moment Synlab is actively doing this primarily in Germany, but there are options beyond that."
In separate news, posted late last month on Epigenomics' website, the company said that it raised approximately €33.1 million in a combination private-public stock sale.
As part of the sale, Epigenomics offered approximately 14.7 million new shares at a price of €2.25 to existing investors, and sold approximately 46 percent, or 6.8 million, of those shares.
The remaining 7.9 million unsubscribed new shares were then sold at the subscription price to retail investors as part of a public offering in Germany and Austria, as well as to selected institutional investors in Germany and abroad.
Plum told PCR Insider this week that the offering was significantly oversubscribed, allowing the company to place all shares.
The company said that a "sizable" portion of the unsubscribed new shares were placed with funds managed by the UK's Abingworth, which also exercised its rights to purchase shares as an existing investor.
Plum said that as a result, Abingworth increased its stake in Epigenomics to about 20 percent from 11 percent.
Epigenomics said that it plans to use the €33.1 million to finance current operations; build and strengthen marketing, sales, and distribution for its products; and support ongoing and new product development for in the areas of cancer screening, diagnosis, disease progression, and recurrence monitoring.
Epigenomics also said that it would use proceeds from its recent financing to fund R&D, clinical trials, regulatory approvals, and market introduction of various products; to further improve its DNA methylation technology; to support additional licensing agreements and patent filings; and for general corporate purposes.
In addition to the Epi proColon test, Epigenomics is also developing a DNA methylation test for lung cancer called the Epi proLung BL Reflex Assay. Epigenomics said that it expects to launch the test as a CE-marked IVD in Europe in the second quarter of 2010.