Lucigen won a $2.8 million phase 2 Small Business Innovation Research (SBIR) grant to support development of a rapid point-of-care (POC) diagnostic testing system for influenza A, B, and respiratory syncytial virus (RSV). The firm says a test product that can accurately diagnose common respiratory viruses in under 30 minutes at point-of-need hasn’t yet been developed. Lucigen’s product will exploit an enzyme technology that the firm claims can convert RNA to DNA and isothermally amplify it within minutes, enabling the development of a cost-effective, portable diagnostic device that doesn’t require microfluidics, pumps, or valves.
“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 setting,” explains David Mead, Ph.D., Lucigen founder and CEO. “We're developing 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.” Lucigen believes the platform could form the basis of a multiplex system for testing a range of serious infectious agents at low resource and battlefield settings, and potentially in the future be developed as an OTC device.
The latest phase 2 SBIR grant is Lucigen’s largest to date. In March the firm was awarded a $2.5 million phase 2 SBIR grant to fund the development of large metagenomic DNA libraries for screening against multiple drug-resistant pathogens. The grant-funded project is a collaboration between Lucigen and researchers at Auburn University and the University of Mississippi.