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Rheonix, Life Tech Developing Automated Molecular Testing System for Applied Markets

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HOUSTON – Rheonix and Life Technologies said this week that they have entered into a joint development agreement to develop and market a version of Rheonix's integrated molecular testing platform for applied markets such as food safety.

For Rheonix, the agreement will serve as a springboard for its platform – the Chemistry and Reagent Device, or CARD, consumable and associated Encompass MDx system – into the clinical diagnostic market, company executives said.

Meantime, the partnership provides Life Tech with a fully automated "sample-to-result" molecular testing system to complement its existing product portfolio for food safety, a Life Tech representative said.

Officials from both companies discussed the agreement at a press briefing at the American Association for Clinical Chemistry meeting held here this week.

Rheonix President Tony Eisenhut said during the press briefing that under the agreement Life Tech will be responsible for the sales, marketing, and distribution, and will serve as a development partner. Rheonix, meantime, will be the consumables partner, supplying the CARD technology and associated reagents.

Life Tech will initially focus on the food safety market, but could eventually use the platform to target other applied markets such as water testing, consumer goods, and agriculture, Eisenhut said.

Rheonix, based in Ithaca, NY, emerged from stealth mode in 2010 by announcing the ongoing development of the CARD technology and several associated molecular diagnostic assays (PCR Insider, 4/29/2010).

The CARD consumable is a disposable cartridge the size of a credit card that is inserted into the Encompass MDx benchtop instrument to run multiple samples through a fully integrated molecular assay (sample extraction, DNA purification, amplification, and array-based endpoint detection) with no user intervention.

The CARD can handle liquid volumes of between 5 µl and 5 ml and tissue mass up to 20 mg, and is compatible with a broad range of sample types including fresh tissue, FFPE tissue, whole blood, serum, saliva, and swabs. This will presumably extend to food matrices through the partnership with Life Tech.

Currently each CARD can run four assays simultaneously, with each assay capable of detecting up to 48 targets.

The company has been developing and tweaking its system for more than three years, and only recently began making it available to those interested in using it for research use and laboratory-developed tests.

However, the company "has not really pushed that agenda at all," Eisenhut told PCR Insider following the briefing. "People have reached out to us and we have sold it to them. We have not proactively marketed it. Our focus has really been to bring it forward in the clinical setting."

The Life Tech agreement, despite its focus on applied testing markets, will provide Rheonix with a source of income and validate its system for high-throughput molecular testing applications.

"It will bring us to scale much quicker," Eisenhut said. "From a manufacturability standpoint, the real cost benefits that are associated with our platform will be realized in a much shorter period of time."

Life Tech, he said, "will have an instrument specific to the needs of the market they're going after. But the guts and the engineering behind that is something we'll be able to use and leverage … and put on our own skin … and a user interface that's more appropriate for the clinical markets."

Rheonix is focusing its clinical development primarily on infectious diseases. "We're looking at a series of panels … [including] a sexually transmitted infection panel that is significantly more comprehensive than is currently available today, and will allow a clinician to be able to assess the situation and make decisions quicker, as opposed to in a serial fashion," Eisenhut said. "And we are looking at [hospital-acquired infections] in the same light, as well as respiratory and gastrointestinal."

Cindy Kephart, a senior manager of program and portfolio management in animal health and food safety at Life Tech, said that the company chose Rheonix as a development partner after a one-and-a-half year search for a technology platform that met "a very specific set of requirements to meet the needs" of the applied testing market. These needs included cost sensitivity and an ability to "bridge a skills gap in terms of running molecular testing" that often exists in applied testing labs.

Life Tech already offers an extensive molecular testing product portfolio for food safety – particularly assays for specific common food-based pathogens – but did not have a fully automated instrument platform to run these assays.

The Rheonix system will offer "a complementary set of solutions," Kephart told PCR Insider following the briefing. "We have a molecular testing suite [for food safety] but nothing automated. We are aiming for a higher throughput testing market … [where] they need the information, but [don't want] the complexity."

Steve Pemberton, vice president of marketing and sales for Rheonix, told PCR Insider that essentially Life Tech is "looking to bring a sample-to-result box" akin to integrated molecular diagnostics platforms into the applied testing market.

"There are not PhDs working in many of these types of labs, and they need something simple, robust, and comprehensive," Pemberton said.

Notably, Life Tech also this week announced a five-year agreement with the US Food and Drug Administration aimed at detecting E. coli and Salmonella – an agreement that could dovetail with the Rheonix partnership.

That agreement will involve, among other components, designing and validating new food safety tests, including a complete workflow for detecting food pathogens on the Ion PGM sequencing platform. In addition, the agreement will call for the FDA to evaluate new pathogen-detection technology platforms from Life Tech.

"The sequencing component from the FDA agreement would be primarily for discovery, whereas you could use that to develop tests and run them on something like the Rheonix system," Kephart said.

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