Dual assay for developing world and beyond

“In the developing world, remote treatment centers take a dipstick test for HIV/AIDS and get a serological result, but can’t run a test to confirm the presence of RNA,” explains Dr. Richard Montagna, senior vice president for scientific and clinical affairs, who served as the principal investigator on the grant. “By putting both serological and molecular assays on one system, the test procedure is self-confirming, giving results right away, possibly preventing the spread of the disease by people who are not aware that they are infected with it.”

Montagna adds, “The problem is that there is a window period where a person may not express antibodies as soon as he or she is contaminated, but can be infective. The person would show up as negative for the virus on a serological test but positive on a molecular assay, and would live in a ‘fool’s paradise’ without the latter. Our system will simplify HIV testing and eliminate the need for multiple patient visits to healthcare providers, which may be difficult in some parts of the world.”

The $1.5-million, 18-month Phase II grant follows the successful completion of a Phase I proof-of-concept grant in the amount of $189,646. In conjunction with researchers at New York University, Rheonix demonstrated the system’s ability to detect both the antibodies against HIV and the actual viral RNA in a fully automated manner.

The additional funding will be used to achieve a commercial-ready test for use in the developing world. Privately held Rheonix “is committed to improving standards of care by making molecular diagnostics available to more people, in more places, more often,” Montagna says. The company hopes to penetrate key molecular diagnostic market sectors, from reference labs through point of care and everywhere in between, through its innovative use of microfluidics.

The researchers at New York University developed the dual assay for HIV and viral RNA, according to Montagna, then Rheonix developed the Chemistry and Reagent Device, or Rheonix CARD, for performing the assay. Once a raw sample is placed on the Rheonix CARD, the automated platform runs with no user intervention through the process of sample extraction, purification, amplification and detection. The cartridge, which is about the size of a credit card, is placed in the EncompassMDx platform, a highly customizable technology that performs fully automated, complex molecular assays in an easy-to-use and economical format. The EncompassMDx is a device about the size of a laptop computer, making it easy to put in a small vehicle to take to a remote location.

The Rheonix system eliminates the need for multiple pieces of existing equipment, helping to make the testing process quicker, more efficient, less expensive and less likely to result in human error. Now a plug-in device, it will eventually run on battery power. Montagna anticipates that a working product could be on the market in 1½ to 2 years.

He concludes, “Being able to provide such a fully automated testing platform will allow resource-limited regions of the world to have their first-ever opportunity to perform simultaneous serological testing and molecular confirmation for HIV on a portable platform run by someone with minimal training.”