New York University College of Dentistry (NYUCD) has received a sub-award in the amount of $335,000 from a Small Business Innovation Research (SBIR) Phase II grant from the National Institutes of Health (NIH) to complete the development of a fully automated self-confirming assay that can simultaneously detect HIV/AIDS antibodies and viral RNA from the AIDS virus in a single specimen.
The $1.5M Phase II grant was awarded to Rheonix, Inc., an Ithaca, New York-based medical technology company, specializing in making automated and highly customizable molecular diagnostic devices. The NYUCD portion of the grant is led by Dr. Daniel Malamud, professor of basic science and craniofacial biology and director of the HIV/AIDS Research Program at NYUCD.
"Current HIV corroborative testing requires considerable time and cost, and is often not available in remote geographic areas," said Dr. Malamud. "As a result, many individuals with a positive antibody screening test opt out of taking the corroborative test. Our research aims to address this problem through the development of an affordable, easy to use point-of-care (POC) test, capable of detecting pathogen nucleic acids and antibodies to the pathogens in less than one hour.
Working with Rheonix, Dr. Malamud and his team utilize a Rheonix CARD® cartridge system: a simple disposable card that acts as a receptacle for blood or saliva samples. The card is then placed on an instrument that carries out all of the required steps in processing the sample. Within seven minutes, one part of the sample runs out onto a strip to detect HIV antibodies, while another portion of the samples undergoes isolation of nucleic acid and amplification using LAMP, an isothermal process. The entire testing process takes less than one hour, is mobile, and can be battery operated.
"In order to get approval, you need to prove that you're as good as the existing commercial equivalent," explains Dr. Malamud. "We have proof that our system works, but we have tested hundreds of samples and we need thousands."
"I'm reasonably confident that within 18 months we will have a finished product, which will allow an individual to simply collect a sample, insert it into the CARD, push a button, and, within one hour, have an accurate test result," says Dr. Malamud.