NEW YORK (GenomeWeb) – Akonni Biosystems announced today it has submitted a molecular diagnostics system to the US Food and Drug Administration for 510(k) clearance. The system can perform multiplex testing using on-slide PCR and microarray technologies.
The system, called TruDiagnosis, consists of the TruDx imager, TruArray consumable test kit, and TruSpot software. The firm did not disclose whether a specific diagnostic assay was submitted along with the TruDiagnosis system.
The submission marks "a significant milestone" for the company, CEO and Founder Charles Daitch said in a statement, representing a critical next step in realizing Akonni's mission "to develop, manufacture, and sell molecular diagnostic tools for rapid, affordable, and accurate diagnoses that have the potential to dramatically improve the health status and cost of healthcare for millions of people worldwide."
The firm will now continue transitioning from a research and development-oriented firm to a fully integrated commercial molecular diagnostics organization, Daitch said, and it anticipates achieving its first FDA clearance and a commercial launch in 2019.
Akonni said that commercial products in the its near-term pipeline include rapid sample preparation technologies for nucleic acid extraction, as well as multiplex panel assays for pharmacogenomics, chronic diseases, and infectious diseases such as multidrug-resistant tuberculosis (MDR-TB), extensively drug-resistant tuberculosis (XDR-TB), upper respiratory infections, viral encephalitis, and hospital-acquired infections such as methicillin-resistant Staphylococcus aureus.
Akonni has been developing a multidrug-resistant tuberculosis (MDR-TB) assay since 2010, as previously reported, and has collaborated in the past with the New York State Department of Health's Wadsworth Center on diagnostic viral arrays, including ones for meningitis/encephalitis and influenza.
The Frederick, Maryland-based company raised $4 million in bridge financing in 2017. It has also won a Phase I Small Business Innovation Research grant from the National Institutes of Health to develop molecular diagnostic tests for lower respiratory diseases in children, NIH funds to finalize development of a rapid, point-of-care tuberculosis assay, as well as a larger SBIR award to support development and commercialization of its TB testing technology.