Micronics Receives NIH SBIR Phase 2 Grant to Advance Rapid Molecular Test for HIV Diagnosis

REDMOND, WA, – Micronics, Inc., today announced that it has been awarded a phase 2, two-year Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) totaling approximately $770,000 to advance its rapid molecular diagnostic infectious disease platform for detection of mother-to-child transmission (MTCT) of the Human Immunodeficiency Virus (HIV).

The overall objective of the NIH grant is to determine whether the MTCT-HIV test that Micronics is developing for point of care applications can provide the same kind of information as the current nucleic acid tests in use today. Under a successful phase 1 effort, Micronics and collaborators at the Centers for Disease Control and Prevention successfully demonstrated the feasibility of HIV detection from a droplet of whole blood applied to a disposable, microfluidics-enabled cartridge containing all of the required reagents and controls. Results showed that the sensitivity observed in the Micronics cartridge was acceptable for qualitative detection of HIV-1 DNA in infected individuals. During the phase 2, Micronics will expand development of its point of care MTCT-HIV assay, including performance of pre-clinical assessment studies to confirm limit of detection and comparison studies against current test methods.

There are two primary challenges associated with today’s current test methods for diagnosis of mothers and infants at risk for HIV infection. The first challenge is that current HIV-1 nucleic acid amplification-based assays generally are too costly and complex to perform at point of care where timely therapeutic intervention or counseling could be provided. The second challenge is that today’s non-molecular tests for HIV infection generally are not useful in screening newborns or young infants. This is due to the fact that all children born to HIV-infected mothers carry maternal antibodies to HIV, produced originally by the mother’s immune system. These maternal antibodies remain in the child’s system for up to 18 months, which could delay treatment.

The Centers for Disease Control and Prevention has recommended regular HIV screenings for high-risk individuals and that HIV screening be made part of the routine panel of prenatal screening tests for all pregnant women. Micronics believes that the MTCT-HIV test it is developing could have significant human health benefits worldwide given that is expected to be performed at reduced cost and in minutes in a doctor’s office, public health lab, remote field hospital, or hospital birthing center.

About Micronics

Micronics is advancing a family of rapid molecular diagnostic tests for infectious disease detection 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. Micronics efforts under this award are supported by NIH Grant Number 2R44AI078851-02. The content of this release is solely the responsibility of Micronics and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health.

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