A Medical Device Daily

Akonni Biosystems (Frederick, Maryland), a molecular diagnostics (MDx) company focused on providing rapid and highly scalable solutions for infectious disease testing, reported the receipt of a $3.2 million Phase II SBIR grant from the National Institutes of Health (NIH; Bethesda, Maryland). The award will enable Akonni to combine PCR with its existing TruArray gel-drop microarray in a single chamber, closed-amplicon system, and field test it for the detection of influenzas A and B and their antigenic subtypes, including antiviral resistant types. This grant is based on the successful completion of an earlier Phase I SBIR, and has as a goal the production of commercial products for clinical and research laboratories.

"The development of highly extensible, low-cost diagnostics for use in near-point-of-care settings is critical for mitigating the spread of disease and improving global health," said Charles Daitch, PhD, CEO of Akonni Biosystems. "Combining PCR and microarray detection in a self contained microfluidic chamber represents a significant advancement to conventional multiplexed molecular diagnostic testing – 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."

With the scaling limitations of current line probe and fluorogenic PCR systems, the new PCR array technology is expected to deliver more cost-effective infectious agent panel testing by providing a level of multiplexing and genetic information only available with microarray technologies. Akonni's first test based on the PCR array technology will be for the detection and subtyping of influenzas A and B. Starting from PCR-ready material extracted from swabs or nasopharyngeal aspirates using Akonni TruTip Extraction Kits, the test will deliver sub-typing results in less than 2 hours and with limits of detection equivalent to those of real-time PCR systems.