LANSING — The National Institutes of Health (NIH) has awarded Rheonix, Inc. a grant as the company works to develop a system that it contends will simplify testing for the human immunodeficiency virus, or HIV. The NIH awarded Rheonix — a town of Lansing–based developer of automated molecular-testing products — a Small Business Innovation Research […]
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LANSING — The National Institutes of Health (NIH) has awarded Rheonix, Inc. a grant as the company works to develop a system that it contends will simplify testing for the human immunodeficiency virus, or HIV.
The NIH awarded Rheonix — a town of Lansing–based developer of automated molecular-testing products — a Small Business Innovation Research (SBIR) Phase I fast-track grant of more than $189,000, the company announced. The firm expects a follow-up, 18-month, Phase II award of about $1.5 million.
Rheonix will use the funding to complete the development of a “fully automated self-confirming assay that can simultaneously detect HIV/AIDS antibodies and viral RNA in a single specimen,” as the firm described it in a news release.
An assay is an investigative (analytic) procedure in laboratory medicine, pharmacology, environmental biology, and molecular biology. RNA is short for ribonucleic acid.
The Rheonix system will “simplify” HIV testing and eliminate the need for multiple patient visits to a health-care provider, the firm contends.
The NIH funding “further validates” the scientific merit of the company’s molecular-diagnostics testing platform, Tony Eisenhut, president of Rheonix, said in the release.
“The success of this program will add a valuable armament to reducing the health burdens of HIV in developing countries and other areas where testing resources are limited,” Eisenhut said.
The large number of people who don’t realize that they’re infected continues fueling the global HIV/AIDS “epidemic,” according to the Rheonix news release.
Governments around the world support various programs encouraging more frequent testing to reduce this number. However, most current testing procedures require that that a second, more sensitive and more specific test confirm any initial positive test, Rheonix said.
In “resource-limited” settings, the initial and confirmatory tests often rely upon simple “dipstick-like” tests that lack the sensitivity and specificity of “more sophisticated” testing, according to the Rheonix news release.
In addition, the second confirmatory test requires a second visit to a health professional that often does not happen.
Rheonix has worked with scientists at New York University (NYU) to develop a unique dual assay that can perform both the initial test and the confirmatory test simultaneously on the same specimen.
Under the terms of the grant, Rheonix will continue to collaborate with NYU as the complex bench-top assay is converted to the Rheonix, fully automated molecular-detection system.
Richard Montagna, Rheonix senior vice president for scientific and clinical affairs, served as the principal investigator on the grant.
“The Rheonix dual-assay system will be the first of its kind in the world able to simultaneously detect the presence of HIV antibodies and confirm the presence of HIV viral RNA in a single test specimen,” Montagna said in the release. “By automating the entire process in a small, portable device, resource-limited regions will have their first-ever opportunity to perform simultaneous serological testing and molecular confirmation for HIV.”
Researchers will perform the assay on the Rheonix Chemistry and Reagent Device, or CARD.
After placing a raw sample on the Rheonix CARD, the automated platform runs with no user intervention through the process of sample extraction, purification, amplification and detection.
The process 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, the company said.
NIH created the SBIR Phase I/II fast-track funding program to expedite funding decisions for Phase II efforts on applications that NIH believes have a “high potential” for commercial success.
A peer-review of a single application for both the Phase I and Phase II portions of proposed development efforts allows the elimination of the normal funding gap between Phase I and Phase II, and expedited progress toward commercialization, according to the news release.
Contact Reinhardt at ereinhardt@cnybj.com
