The $656,414 award is an administrative supplement to an existing Small Business Innovation Research (SBIR) Phase I/II Fast-track grant from the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH). The grant will allow the Rheonix/NYUCD team to pursue the development of a fully automated screening and self-confirming assay that will simultaneously detect and confirm the presence of Zika virus in a single, small sample of saliva or blood. The proposed approach will build upon previous success in which the Rheonix/NYUCD team developed a dual assay for the simultaneous detection of HIV antibodies and viral RNA in a single specimen.
The assay will be performed on the Rheonix Chemistry and Reagent Device, or Rheonix CARD® cartridge interfaced with the Encompass Optimum™ workstation. Once a raw sample is placed on the Rheonix CARD cartridge, the automated workstation 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.
“As we continue to demonstrate the utility of our novel microfluidic-based technology, we remain committed to deploying the technology to address global health needs,” said Greg Galvin, Ph.D., CEO and chairman at Rheonix. “Addressing the need to test for Zika virus certainly fits the bill given the elevated health alerts issued throughout the world.”
In February 2016, the World Health Organization (WHO) declared Zika virus a public health emergency of international concern. According to the Centers for Disease Control and Prevention (CDC), Zika virus disease is caused by Zika viruses that are spread to people primarily through the bite of an infected Aedes species mosquito; however, transmission from mother to child, through sexual contact and through blood transfusion have also been reported. According to the NIH, there is a tentative link between Zika virus infections in pregnant women and microcephaly, a condition characterized by a small head and brain, in their newborn babies. In addition, a possible connection exists between Zika infection and Guillain-Barré syndrome, a condition in which the immune system attacks parts of the peripheral nervous system.
“We have had a long-standing and very productive collaborative relationship with Dr. Dan Malamud’s laboratory at New York University College of Dentistry, and it has been through those efforts that we successfully developed the dual assay for anti-HIV antibodies and viral RNA,” said Richard Montagna, Ph.D., FACB, senior vice president for scientific and clinical affairs at Rheonix, and the principal investigator on the grant. “It seemed to be a logical extension of those efforts to attempt the same approach for Zika virus.”
“The Zika virus appears to disappear from blood in six to 10 days, but is still detectable in saliva and urine,” explained Daniel Malamud, Ph.D., professor of basic sciences at NYUCD. “Anti-Zika antibodies can be detected several days after infection. A combined RNA and antibody test will enable detection of both early and late Zika virus infections.”