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NIH awards Lucigen $2.8 million SBIR grant
MIDDLETON, Wisc.—Lucigen Corp. has announced that it has received $2.8 million from the National Institutes of Health in a Small Business Innovation Research (SBIR) grant to fund the research and development of a point-of- care diagnostic test for influenza. The grant represents the company's largest SBIR Phase II grant to date, and the funding will be used to develop a point-of-case diagnostic testing device for influenza A, B and respiratory syncytial virus (RSV).
"As a pioneer in cloning, enzyme discovery and metagenomic studies, Lucigen is now set to leverage its previous breakthroughs into real-world healthcare applications. We plan the world's first nucleic acid-based test for viral infections that is cost-effective and can be safely and easily used directly at the physician's office, eliminating the need to send the sample off to central testing laboratories," David Mead, Ph.D., founder and CEO of Lucigen, said in a press release. "DNA or RNA based tests have repeatedly shown greater sensitivity and specificity over commonly used 'rapid ' immunochemistry-based testing methods, but have not been simplified to the extent that they can be moved to a POC situation. Our solution has the potential to significantly advance sensitivity and time to results, thus improving patient treatment and outcomes."
Though respiratory infections consistently have a significant presence worldwide, current test products for the diagnosis of such infections, including influenza, do not offer diagnosis in the timeframe ideal for implementing antiviral treatments. With the receipt of this grant, however, Lucigen will work to develop a device and reagents for the molecular diagnosis of multiple RNA pathogens to facilitate a faster standard for patient diagnosis.
The key for such technology will be the development of a novel enzyme capable of converting RNA to DNA and isothermally amplifying it in a matter of minutes, characteristics that allow for a device that does not require microfluidics, pumps or valves. Such a technology is ideal for both low-resource and battlefield settings, the company noted in a press release, with additional long-term potential as an over-the-counter device.
The grant is the second large SBIR grant that Lucigen has received this year. In early March, Lucigen announced that it had been awarded a SBIR Phase II grant of $2.5 million for the development of metagenomic DNA libraries for the identification of antimicrobial and anti-infective drug candidates. The grant supports Lucigen's ongoing work in the realm of metagenomics, as with a previous Phase I grant, the company worked with scientists from Auburn University to create a DNA library from soil microbes, an effort that resulted in 28 new compounds that inhibit the growth of methicillin-resistant Staphylococcus aureus (MRSA).
The company's partners for the Phase II SBIR grant are Auburn University and the University of Mississippi. Together, the partners will create several large metagenomic libraries, which will then be screened for antimicrobial activity against four multiple-drug resistant pathogens. Lead candidates that display high potency against multiple pathogens will then be evaluated for efficacy via an in-vivo MRSA assay. The resulting libraries will also offer a resource for researchers scanning for anticancer, antifungal or antiviral compounds.
SOURCE: Lucigen press release