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Rheonix Wins $233K NIAID Grant to Add UTI Detection to Multiplex STD Molecular Dx

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The National Institutes of Health has awarded Rheonix $233,000 to support broader development of the company's fully automated point-of-care molecular diagnostic platform for detecting multiple sexually transmitted diseases, Rheonix said this week.

The award, administered by the National Institute of Allergy and Infectious Diseases, will supplement a $397,000 grant bestowed to Rheonix by NIAID earlier this year to further develop its platform, called the Chemistry and Reagent Device, or CARD, to also detect urinary tract infections from patient samples.

NIAID also awarded Rheonix a grant worth just over $400,000 in 2009 to develop the technology for STD detection.

Richard Montagna, Rheonix's senior vice president for corporate business development and scientific affairs, told PCR Insider this week that the long-term goal of the project is to develop a single platform for detecting an array of STDs and UTIs with just one testing platform.

Rheonix, based in Ithaca, NY, emerged from stealth mode in April by announcing it had netted $12.6 million in Series A financing and that it was developing several in vitro diagnostic assays for the CARD platform, including tests for warfarin sensitivity, HPV, HIV, and sepsis (PCR Insider, 4/29/10).

And earlier this month, at the American Association for Clinical Chemistry annual meeting in Anaheim, Calif., Rheonix presented data from research studies demonstrating the use of the CARD system for detecting in human subjects warfarin sensitivity, human papillomavirus, and four sexually transmitted infectious agents — N. gonorrhoeae, C. trachomatis, T. palladium, and T. vaginalis — either singly or in multiplex (PCR Insider, 8/5/10).

The CARD system currently comprises a CARD module, with about the footprint of a credit card; and either a benchtop automation instrument or smaller, more portable, POC instrument.

The system can automatically isolate and lyse infectious agents; extract and purify DNA and/or RNA; and PCR amplify and detect target sequences from a variety of patient samples. Thus far, the company has successfully processed whole blood, plasma, saliva, and vaginal swabs, according to the NIAID grant's abstract.

To improve the ease of use of the current CARD system, the NIAID-funded project will further integrate the use of stable liposomes with at least three-year real-time stability to increase signal intensity and simultaneously transduce the biological signal into an electronic one, according to the abstract.

"This will be accomplished by conjugating oliogonucleotide probes that are complementary to portions of the amplified target sequences, to the exterior surface of liposomes which, in turn, will encapsulate electroactive compounds," the grant's abstract states. "The resulting liposome-target complexes will be subsequently magnetically immobilized within the microfluidic channels of the CARD by use of magnetic beads conjugated to other oligonucleotide probes that are complementary to another region of the target sequences."

Then, following lysis of the immobilized liposomes, the released electroactive compounds will flow onto the surface of an "interdigitated ultramicroelectrode array where a continuous and reversible redox reaction will generate electric current that will be directly proportional to the concentration of the analyte," Rheonix said.

The upshot is that "individuals of varying degrees of training (including unskilled)" will be able to perform "sophisticated molecular diagnostics … since once the sample is introduced all preparative, analytical, and readout functions are automatically performed," the company said.

In a statement, Rheonix President Tony Eisenhunt said that the supplemental grant "further validates our scientific approach as we continue to make excellent progress toward completing a fully automated CARD device for the rapid molecular detection of multiple sexually transmitted diseases."

Rheonix has not provided a timeline for development of the combined STD/UTI test. The NIAID-funded project is slated to expire in April 2013. Rheonix has said that its first order of business would be to submit its warfarin sensitivity genotyping test for 510(k) clearance from the US Food and Drug Administration by the end of the year; followed by its HPV test.

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