Molecular diagnostics company Akonni Biosystems won a $3.2 million phase 2 SBIR grant from the NIH to fund the development of a fast, low-cost flu diagnostic system that can detect influenzas A and B and their antigenic subtypes including antiviral-resistant strains. The aim is to develop and field-test a diagnostic that combines PCR with Akonni’s TruArray gel-drop microarray technology in a single-chamber, closed-amplicon system.
The grant was awarded following successful completion of an earlier phase 1 SBIR project and is focused on the development of commercial products for clinical laboratories as well as research use. The new product is expected to be able to deliver subtyping results in less than two hours from PCR-ready material extracted from swabs or nasopharyngeal aspirates using Akonni’s TruTip extraction kits. It should also have detection limits equivalent to those of real-time PCR systems, the company says.
“Combining PCR and microarray detection in a self-contained microfluidic chamber represents a significant advancement to conventional multiplexed molecular diagnostic,” claims Charles Daitch, Ph.D., Akonni’s CEO. “The capability will further enhance our ability to rapidly develop and deploy even more comprehensive panels for detecting multiple pathogens and their variant forms in a single sample.”
The flu test project will see Akonni partner with Wadsworth Center, Columbia University, Little Company of Mary Hospital, and the U.S. CDC. Wadsworth is developing a focused panel of drug-resistance markers for the PCR array platform and will provide clinical feedback for product development and participate in preclinical verification of the technology on clinical specimens. The first test is expected to be used to detect and subtype influenzas A and B.
Akonni’s TruArray platform is a microscopic gel-drop array molecular system that the company claims differs from competing microarray products in that capture probes are covalently attached to an ultrahigh surface area polymer backbone of discrete 3-D gel-drops rather than a 2-D substrate. The individual gel drops effectively behave as nanoliter, solution-phase test tubes, which Akonni says avoids unpredictable and/or uncharacterized artifacts arising from probe deposition directly on a 2-D surface. Akonni’s range of products are currently only available for research use.
Akonni launched its TruTip product line in November. Designed for extracting DNA and RNA from samples with volumes ranging from 100 µl to 1000 µl or more, the patented TruTip approach uses a nucleic acid binding matrix that is easily inserted into most standard pipette tips including those used by electronic pipettes and liquid-handling robotic devices. By passing sample back and forth across the binding matrix, TruTip delivers inhibitor-free, PCR-ready nucleic acid from a variety of sample types including blood, plasma, sputum, urine, and challenging matrices such as soil or water. Akonni claims the platform works equally well with both DNA and RNA isolated from viruses, bacteria, or animals.