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After Launch of RUO System, Rheonix Eyes Further Market Opportunities

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NEW YORK (GenomeWeb) – Following the launch of its research-use-only (RUO) molecular testing platform, Rheonix has begun putting into place the first of its three planned major revenue drivers, all of which are based around the company's core Chemistry and Reagent Device (CARD) consumable and related instrumentation.

Dubbed Encompass Optimum, the system is designed to run user-customized sample-to-answer CARD assays for non-clinical research. And while Rheonix sees the potential for the platform for RUO applications, the firm has its sights fixed on the markets in which it sees the most value: in vitro diagnostics, applied markets, and next-generation sequencing (NGS) sample preparation.

The CARD is a disposable cartridge the size of a smartphone that is used in combination with Rheonix's Encompass bench-top system to run multiple samples through a fully integrated and automated molecular assay that handles sample extraction, DNA purification, PCR-based amplification, and array-based endpoint detection. It is compatible with a range of sample types such as fresh tissue, formalin-fixed paraffin-embedded tissue, whole blood, serum, saliva, and swabs.

Last month, the company unveiled Encompass Optimum, which can run high-throughput and high-complexity assays with minimal user intervention, and features open software allowing users to build their own assays.

The company expects to begin generating revenues from the RUO system this year, but the product really represents a springboard of sorts for EncompassMDx, which is essentially the same instrumentation branded for use with upcoming CARD-based molecular diagnostics assays, according to Steve Pemberton, vice president of sales and marketing at Rheonix.

As previously reported by GenomeWeb, the first EncompassMDx test will be STI Tri-Plex, which features probes targeting markers associated with Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

Richard Montagna, senior vice president for scientific and clinical affairs at Rheonix, said that the test remains on track for submission to the US Food and Drug Administration this year. He noted that the company has hired a contract research organization to oversee clinical trials of the assay, which will involve comparing it against two predicate tests, with the studies beginning in the "next couple months."

Pemberton added that the firm also has "a very active program underway for a follow-on assay," but said that specifics about that effort are being kept under wraps for now. Previously, however, the company has said it is interested in the hospital-acquired infection, respiratory, and gastrointestinal markets.

The company also recently received a $1.5 million Phase II Small Business Innovation Research grant from the National Institutes of Health to finish development of an assay to simultaneously detect HIV/AIDS antibodies and viral RNA in a single specimen. With the help of a Phase I grant, the firm was able to demonstrate that the CARD technology could detect both antibodies against HIV and actual viral RNA in a fully automated manner.

In addition to its in vitro diagnostics play, which includes Encompass Optimum, Rheonix is going after the applied markets space, Pemberton said. This effort includes an assay under development for the detection of spoilage organisms in beer microbrews, wines, and ciders, Pemberton said. The firm is also collaborating with Life Technologies to develop its CARD technology for food safety testing under a 2013 deal.

Lastly, Rheonix is looking to leverage the sample flexibility of its CARD consumable to offer a product for NGS sample preparation, which Montagna noted is "a very labor-intensive process and one of the bottlenecks in NGS."

Pemberton described this program as longer-term play, stating that while Rheonix expects to be able to bring something to the market fairly quickly, additional development is still needed.

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