NIH awards Lucigen $2.8 million SBIR grant

MIDDLETON, Wisc.—Lucigen Corp. has announced that it hasreceived $2.8 million from the National Institutes of Health in a SmallBusiness Innovation Research (SBIR) grant to fund the research and developmentof a point-of-care diagnostic test for influenza. The grant represents thecompany's largest SBIR Phase II grant to date, and the funding will be used todevelop a point-of-case diagnostic testing device for influenza A, B andrespiratory syncytial virus (RSV).

"As a pioneer in cloning, enzyme discovery and metagenomicstudies, Lucigen is now set to leverage its previous breakthroughs intoreal-world healthcare applications. We plan the world's first nucleicacid-based test for viral infections that is cost-effective and can be safelyand easily used directly at the physician's office, eliminating the need tosend 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 haverepeatedly shown greater sensitivity and specificity over commonly used 'rapid'immunochemistry-based testing methods, but have not been simplified to theextent that they can be moved to a POC situation. Our solution has thepotential to significantly advance sensitivity and time to results, thusimproving patient treatment and outcomes."

Though respiratory infections consistently have asignificant presence worldwide, current test products for the diagnosis of suchinfections, including influenza, do not offer diagnosis in the timeframe idealfor implementing antiviral treatments. With the receipt of this grant, however,Lucigen will work to develop a device and reagents for the molecular diagnosisof multiple RNA pathogens to facilitate a faster standard for patientdiagnosis.

The key for such technology will be the development of anovel enzyme capable of converting RNA to DNA and isothermally amplifying it ina matter of minutes, characteristics that allow for a device that does notrequire microfluidics, pumps or valves. Such a technology is ideal for bothlow-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 hasreceived this year. In early March, Lucigen announced that it had been awardeda SBIR Phase II grant of $2.5 million for the development of metagenomic DNAlibraries for the identification of antimicrobial and anti-infective drugcandidates. The grant supports Lucigen's ongoing work in the realm ofmetagenomics, as with a previous Phase I grant, the company worked withscientists from Auburn University to create a DNA library from soil microbes,an effort that resulted in 28 new compounds that inhibit the growth ofmethicillin-resistant Staphylococcus aureus (MRSA).

The company's partners for the Phase II SBIR grant areAuburn University and the University of Mississippi. Together, the partnerswill create several large metagenomic libraries, which will then be screenedfor antimicrobial activity against four multiple-drug resistant pathogens. Leadcandidates that display high potency against multiple pathogens will then beevaluated for efficacy via an in-vivoMRSA assay. The resulting libraries will also offer a resource for researchersscanning for anticancer, antifungal or antiviral compounds.

SOURCE: Lucigen press release