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GenePOC Gets Additional Debiopharm Investment; on Track to Launch Spinning Disk PCR Platform

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NEW YORK (GenomeWeb) –GenePOC announced this week that Swiss pharmaceutical company Debiopharm has invested "tens of millions of dollars" into accelerating development of the Quebec City-based firm's molecular diagnostic platform and infectious disease assays.

The new funding will be used to support commercialization as well as to "continue our new assay development and have a constant flow of approximately two assays per year launched into the market," Herbert Torfs, GenePOC's vice president of business development and strategy, told GenomeWeb in an email.

The exact amount of the funding from Debiopharm was not disclosed. Debiopharm has invested in GenePOC previously, as well as in firms such as Biocartis, Diagnoplex, Spinomix, Immunexpress, and Agendia.

Debiopharm ultimately plans to pair its pharmaceutical offerings with testing. "On top of the antibiotics that we are developing, we want to offer rapid diagnostics and a system which ensures that treatments are monitored," Thierry Mauvernay, co-president and delegate of the board of Debiopharm Group, said in a statement announcing the funding. Specifically, Debiopharm is developing highly targeted antibiotics against all types of staphylococci, Mauvernay said.

"Before long, every hospital ward and pharmacy will have GenePOC technology: these tests will make it possible to prevent illnesses and treat patients quickly with the right medicines ... to ensure the best support for quick results at a lower price," Mauvernay said.

Initially developed at the Centre de Recherche en Infectiologie at the University of Laval in Québec City, GenePOC's PCR-based testing platform utilizes spinning disc technology and performs fully automated, real-time PCR on cartridges called PIES in less than one hour, as previously described by GenomeWeb.

As part of the arrangement, the firms will also develop new infectious disease assays for Debiopharm, and the company will set up a production line in Valais, Switzerland to manufacture GenePOC-branded test cartridges, Torfs said.

These cartridges can contain multiplex PCR assays of up to 12 targets. For example, a carbapenem-resistant enterobacteriaceae PIE cartridge in development targets resistance genes KPC, OXA, VIM, IMP, and NDM-1, and also contains a process control, according to Torfs.

Although assay manufacturing capability will now be set up at Debiopharm, Torfs noted that GenePOC has no plans to move its instrument manufacturing outside of Québec.

GenomeWeb reported last year that GenePOC was expanding and planning for a European launch of assays for Group B Streptococcus and Clostridium difficile in 2016.

"We are still on track for launches of those two assays in Europe before the end of the calendar year," Torfs confirmed.

The company is also on track to submit the assays to the US Food and Drug Administration, he said, with the GBS assay likely to be submitted in early fall and C. diff by the end of the year.

Meanwhile, "CE marking is underway and [we] expect to have the GBS completed by end of September and C. diff only few weeks after," Torfs added. The firm is also currently running clinical trials on the GBS test, and will start trials on the C. diff test this month.

GenePOC had previously stated a desire to set up distribution relationships for its platform and tests in Europe. Now, the firm is closing agreements with "key partners in various European countries," Torfs said, and expects to make announcements "in a few weeks when the process is completed and we announce the start of our commercialization in the European market."

Beta testing of the assays in Canada also is ongoing. "The testing has given great results and the performance of the assays so far has been at or above our target expectations in all respects, generating a solid, reportable, clinically useful result," Torfs said.

The company's CEO, Patrice Allibert, presented preliminary results of the beta testing at the Next Generation Dx summit held in Washington, DC last week. "The feedback after the talk and during the tradeshow was highly motivating and confirm[ed] the strong performance of our system in a real testing environment," Torfs said.

Allibert noted in a statement, "There is a good synergy between the menu GenePOC will develop and Debiopharm’s strategy and this will allow us to become a major player in the area of point-of-care molecular diagnostics for infectious disease, and also create a large number of new jobs."

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