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Rheonix Readying EncompassMDx Platform, Sexually Transmitted Infections Test for FDA Submission

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NEW YORK (GenomeWeb) – Rheonix will soon begin a clinical trial for a microarray-based test for sexually transmitted infections with the aim of submitting the assay to the US Food and Drug Administration for clearance next year.

President Tony Eisenhut said that the Ithaca, NY-based molecular diagnostics company has used the $14 million it raised last year to finish the development of its EncompassMDx platform and Rheonix CARD cartridges and is now ready to continue on its path to the clinical market with its debut test, dubbed STI Tri-Plex.

"The EncompassMDx and CARD will enter a clinical trial for sexual transmitted infections prior to the end of the year," Eisenhut told BioArray News this week.

Eisenhut noted that the funds Rheonix raised last year have also allowed the company to "fully develop and validate" its manufacturing facility in Ithaca, and will support the firm's needs "through the clinical trial and continued operations."

Rheonix began in 2003 as a research group within Kionix, an Ithaca-based manufacturer of accelerometers, gyroscopes, and microfluidics. The privately held firm became independent from Kionix in 2008. The company's flagship offering is its EncompassMDx system, a benchtop instrument that automates the processing and detection of assays run using its microfluidic CARD (chemistry and reagent device) cartridges. Using the CARD cartridges, users can run both quantitative PCR assays as well as its low-density HyFi microarray assays.

Rheonix claims that the CARD can handle liquid volumes of between 5 µl and 5 ml and tissue mass up to 20 mg. The consumable is compatible with diverse sample types, such as fresh tissue, FFPE tissue, whole blood, serum, saliva, and swabs.

According to Eisenhut, the EncompassMDx platform can be used for molecular diagnostics, food safety testing, companion diagnostics, and for sample preparation for next-generation sequencing. "The addressable market for our products based on the same underlying technology is over $13 billion dollars," he said.

The first test in the company's pipeline is STI-Triplex. The probes on the array target markers associated with Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. While the company will arguably have no shortage of competitors should it gain FDA clearance for the assay – Roche, Cepheid, Abbott, Gen-Probe, and Hybribio are among those selling RT-PCR kits for CT and NG testing – Rheonix is touting its offering as unique, given its automation and multiplexing capabilities.

"The Rheonix STI Tri-Plex assay will be a first of its kind, fully automated panel for the most common and highest prevalent STIs," Steve Pemberton, Rheonix's vice president of marketing and sales told BioArray News. "On approval, this test will allow laboratories to consolidate manual workflows for Trichomonas vaginalis with routine Chlamydia and Gonorrhea testing," Pemberton said.

According to Pemberton, almost 80 percent of testing for TV today is performed using manual microscopy, culture, or direct DNA probes. "Our test will bring the sensitivity and specificity of molecular testing, along with the workflow benefits of sample-to-result automation to this area of the lab," said Pemberton. "In addition, an approved Tri-Plex assay will allow for symptomatic testing of patients which can speed diagnosis and promote the administration of effective therapies with minimal wasted time," he said.

IP position

While Rheonix moves ahead with its plans to bring STI-Triplex to the clinical market, the company has also worked to strengthen its IP position. Since 2009, the US Patent and Trademark Office has awarded Rheonix 20 patents, including six since January.

"We have taken a very systematic approach to our IP," said Pemberton, "first with protecting the manufacturability of the CARD, what we can functionally do on the CARD with pumps, structures, and biology; then, how our CARD interacts with the underlying manifold which drives many of the processes through the controlled application of pneumatics and vacuum; and finally protecting the entire packed instrument unit including touch screen user interface."

Though it has not yet been published yet, the company announced last week that it had received US Patent No. 8,852,919, "Microfluidic Apparatus, Method, and Applications," calling the IP in a statement a "game-changing achievement" that will "serve to increase the rate of adoption for [next-generation sequencing] instruments throughout the healthcare spectrum of reference and specialty laboratories, major university research and medical systems, to hospitals in communities everywhere, by removing the front-end bottleneck in NGS library preparation."

According to Pemberton, the '919 patent establishes the firm's capability to "take a paraffin-embedded tissue sample and process it through deparaffinization and un-crosslinking the tissue to purify and amplify the sample." A described liquid-liquid extraction phase will "allow workflow automation for NGS sample prep that will enable and speed the adoption of NGS instrumentation into the clinical laboratory space," he said.

Richard Montagna, senior vice president for scientific and clinical affairs, discussed the ramifications of the '919 patent during the recent BTIG Emerging Technologies in Healthcare Diagnostics symposium, held in New York last week. Rheonix has discussed its technology at several conferences in recent months. In August, Zongyuan Chen, a senior research engineer at Rheonix, gave a talk on the firm's technology at Beijing University of Chemical Technology, School of Information and Technology.

When asked about its interest in the Chinese market, Pemberton said that Rheonix is "continually evaluating market opportunities" for its technology. "China's diagnostic market is rapidly developing and represents an attractive opportunity for us," said Pemberton. "In addition, China is on the cutting edge in areas such as next-generation sequencing through BGI, and this opens some interesting opportunities for partnership and commercialization," he added.

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