Micronics, Inc., a leading provider of custom lab card design, development, and production services for the global health market, today announced that it has been awarded a $100,000 Small Business Innovation Research grant to advance its diagnostic test to detect Human Immunodeficiency Virus (HIV) at point of care.
The grant, from the National Institute of Allergy and Infectious Diseases under the National Institutes of Health (NIH), will help Micronics determine whether its rapid nucleic acid test to diagnose HIV is comparable in both sensitivity and specificity to the only FDA licensed diagnostic nucleic acid test in use today.
The project is expected to demonstrate the detection of HIV in a droplet of blood applied to a small disposable cassette that contains all of the required reagents and controls to perform a nucleic acid assay. Dr John Gerdes, Chief Scientific Officer for Micronics, will serve as the Principal Investigator under this award.
According to Karen Hedine, CEO and President of Micronics, the current nucleic acid test method requires that a blood sample be taken and sent to a central reference laboratory for analysis, with results provided at a later date. The time lag between sample collection and result means that at-risk individuals may not be readily accessible to the caregiver once test results are known. In addition, she said, the current approach generally requires technical training, expensive, specialized equipment, a reliable power source, and expensive reagents and test kits.
The overall objective of the NIH grant is to determine whether our test can provide the same kind of information as the current nucleic acid test in use today, Hedine said. If this can be proven, we believe that our application will offer significant human health benefits, given the fact that it can be performed at reduced cost and in minutes in a doctorÂ™s office, public health lab, remote field hospital, or hospital birthing center, Hedine added. It is imperative that cost-effective and highly accurate methods to screen for HIV be developed and proven before such screening can happen at a global level, she said.
In contrast to the FDA approved nucleic acid test, another category of commonly used HIV diagnostic tests uses antibodies and may be performed quickly at point of care. However, the current antibody-based tests cannot determine the infectious status of a newborn child for as long as 18 months due to the presence of maternal antibodies, Hedine said. Because early HIV detection and intervention can have a significant impact on infant survival and overall quality of life, a rapid qualitative molecular test is vital, Hedine added.
The CDC recommends regular HIV screenings for high-risk individuals and further recommends HIV screening be made part of the routine panel of prenatal screening tests for all pregnant women. An HIV test that uses MicronicsÂ™ technology could have significant human health benefits worldwide according to Hedine. Not only would it help deliver clinical and prevention services; in the case of pregnant women who may not be aware of their infection, if such tests were employed prior to the third trimester of pregnancy, appropriate medical intervention with anti-retroviral therapy could further reduce transmission.
Micronics is advancing a family of rapid molecular diagnostic tests that may be performed wherever the need for timely and accurate information is most vital to patient care. In addition to its own product development endeavors, the company offers custom lab card design, development and production services on behalf of clients worldwide. For additional information please visit www.micronics.net.
MicronicsÂ™ efforts under this award are supported by NIH Grant Number R43AI078851.
Karen L. Hedine, President/CEO, 425-895-9197, x 126