MBio Diagnostics, Inc. has announced it has received an award from the US National Institutes of Health to detect disease-causing respiratory pathogens in humans.
The five-year, $5.2 million award from NIH's "Partnerships for Biodefense" program will address two major public health needs: a rapid, inexpensive influenza diagnostic with performance superior to commonly used flu tests; and rapid deployment during public health screening emergencies such as the 2009 H1N1 influenza pandemic or a bioterror event.
According to MBio's CEO, Chris Myatt, current rapid flu tests aren't very sensitive - a person who receives a negative result may in fact have influenza. Dr. Myatt noted that during the 2009 pandemic "we saw how rapid flu tests run in clinics were of limited utility. Laboratory based molecular tests provided much better accuracy, but were more expensive and results took days to get back to the patient."
He added that the goal of the NIH-funded program is to develop a nucleic acid-based test that delivers the accuracy of the laboratory diagnostic in an easy-to-use, inexpensive format that can be run while the patient waits. "Enabling the physician to make immediate and appropriate drug decisions not only benefits the patient, it can improve public health by quickly identifying infectious individuals in a population."
Michael Lochhead, MBio's VP and award principal investigator, added that the new system will build on the point-of-care diagnostics platform already under development at MBio.
Lochhead continued, "Our multiplexed immunoassay and cell counting devices are working extremely well in pre-commercial field testing as we prepare for regulated clinical trials. The new NIH award will allow MBio to expand our product pipeline to include increasingly important molecular diagnostics applications."
Dr. Lochhead added that the ability to quickly reconfigure the test in response to a new or emerging infectious agent is a major goal of the research program.
The NIH-funded MBio partnership includes globally recognized viral disease experts at the University of California, San Diego, as well as collaborators at the Program for Appropriate Technology in Health (PATH), headquartered in Seattle.