ITHACA, N.Y. — Rheonix, Inc., a developer of fully automated molecular testing solutions, has received a Small Business Innovation Research (SBIR) Phase II grant, under Award Number R44DE024456, from the National Institute of Dental & Craniofacial Research (NIDCR) of the National Institutes of Health (NIH). The grant will allow Rheonix to complete the development of a fully automated self-screening and confirming assay that can simultaneously detect HIV/AIDS antibodies and viral RNA from the AIDS virus in a single, small sample of noninvasively collected saliva or blood specimen.
The Rheonix system will simplify HIV testing and eliminate the need for multiple patient visits to health care providers, which is especially critical in resource-limited settings. The system is highly sensitive, specific, reproducible and robust for simultaneous screening and confirming HIV infection. The ability to simultaneously detect both anti-HIV antibodies and viral RNA will offer significant advantages over commercially available products because seropositive results can be immediately confirmed. In addition, detection of viral RNA addresses the well-known seronegative “window period” observed in recently infected individuals. This capability will aid health care workers in making appropriate treatment decisions with such individuals who might otherwise not been categorized as infected.
The $1.5 Million, 18-month Phase II grant follows the successful completion of the Phase I proof of concept grant in the amount of $189,646. The additional funding will be used to achieve a commercial-ready test for use in the developing world.
“The funding and support from the NIH, NIDCR validates our technology. The broad applicability of a combined HIV screening and confirmatory test will have a significant health, commercial and social impact that we’re excited to see materialize,” said Tony Eisenhut, president, Rheonix.
The global HIV/AIDS epidemic continues to be fueled by the large number of individuals who are unaware they are infected, or who have limited access to advanced diagnostics. Governments and nongovernmental organizations (NGO’s), around the world support various programs to reduce the impact of the disease by encouraging more frequent testing. Current technologies require confirmation of a positive test result by a second, more sensitive and more specific test. In resourcelimited settings, the initial and confirmatory tests often rely on simple “dipstick-like” tests that lack the sensitivity and specificity of more sophisticated testing. In addition, the second confirmatory test requires a second visit to a health professional that often does not take place.
Richard Montagna, Ph.D., FACB, senior vice president for scientific and clinical affairs, Rheonix, served as the principal investigator on the grant. “In collaboration with scientists at NYU, our Phase I studies were completed on time and as originally proposed whereby we demonstrated our system’s ability to detect both the antibodies against HIV and the actual viral RNA in a fully automated manner. 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.”
The assay will be performed on the Rheonix Chemistry and Reagent Device, or Rheonix CARD® . 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. This 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.
For more information, visit www.rheonix.com.