NEW YORK (GenomeWeb) — Akonni Biosystems said today that it has received a three-year, $3 million Phase II Small Business Innovation Research (SBIR) contract from the National Institutes of Health to continue work on a device to purify DNA from sputum for tuberculosis testing.
According to Akonni, the device — which is being developed in collaboration with researchers from Johns Hopkins University and nonprofit research organization MRIGlobal — can process high-volume sputum samples for PCR-based Mycobacterium tuberculosis detection at smear-negative, culture-positive levels on any downstream diagnostic platform. Earlier development was funded with an Phase I SBIR award in mid-2016.
With the Phase II contract, Akonni aims to refine the device to meet the requirements of low-resource settings such as dust-protection, battery power, and user interface, as well as transfer the device to commercial GMP production. The Frederick, Maryland-based company added that the system will be validated using a real-time PCR detection test for tuberculosis to determine analytical and clinical sensitivity of the method as compared to a standard laboratory method.
"Our approach was to reduce the complexity of the instrument by limiting the automation, streamlining the workflow, and simplifying the user interface," Rebecca Holmberg, director of application development for Akonni, said in a statement. "The simple design lowers the demand on power consumption of the device so that it can run on battery power, and be controlled by a mobile phone application, which further simplifies the ease of use."
In late 2017, Akonni won a $300,000 NIH grant to develop a rapid, point-of-care tuberculosis assay for use on its TruDx 3000 sample-to-answer diagnostic system. In August, it was awarded a $3 million SBIR grant to further develop the assay.