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Micronics Nets $1.2M in NIH Grants for MDx Development

NEW YORK (GenomeWeb News) – The molecular diagnostics firm Micronics has reeled in two grants from the National Institute of Allergy and Infectious Diseases totaling $1.2 million to develop nucleic-acid based diagnostic tests, the company said today.

Under one grant, the company will develop a test for mother-to-child-transmission (MTCT) of the human immunodeficiency virus, and it will use another to develop a test for known and emerging respiratory infections.

The firm will receive a roughly $770,000 Small Business Innovation Research grant to fund the HIV test program, and approximately $440,000 from a Small Business Technology Transfer grant to support development of the respiratory disease diagnostic.

The two-year, Phase II SBIR grant from NIAID will continue work the company began through a collaboration with the Centers for Disease Control and Prevention. That Phase I collaboration with CDC showed that it is feasible to detect HIV from a droplet of blood applied to a disposable, microfluidics-enabled cartridge that contains the necessary reagents and controls.

The Redmond, Wash.-based company said that there currently are two primary challenges to diagnosing mothers and infants at risk for HIV infection. Current tests for HIV are "too costly and complex to perform at point-of-care," and they "are generally not useful in screening newborns or young infants," it said.

The goal of the overall program is to find out if the rapid, point-of-care test the company is developing can be used to provide the same information as other nucleic acid tests that are already in use.

CDC has recommended regular HIV screenings for high-risk individuals and that HIV screening should be made part of prenatal screening tests for all pregnant women.

The company will use the STTR grant to combine two platforms for diagnosing respiratory pathogens at low levels, and it will work with collaborators at the Seattle Children's Research Institute (SCRI).

The collaborators will use a novel primer design method that enables detection of distantly related gene sequences along with the company's molecular diagnostic platform.

The PCR method, developed by SCRI researchers, uses a technique called consensus-degenerate hybrid oligonucleotide primer method (CODEHOP). The CODEHOP technology makes it possible to target conserved sequences within a pathogen family in order to identify known and unknown variants of the pathogen.

The company will use sequences generated using this technology to develop a microfluidics-based system for detecting specific respiratory disease infections, including emerging respiratory viruses, in a point-of-care format.

Micronics said that currently available multiplex tests fail to detect viral pathogens in over 50 percent of samples that are positive for the disease. "A likely explanation for this is that there are unknown or conserved sequence-variant viruses that these current tests miss," the company said.

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