Therapy Areas: Devices
Akonni Biosystems passes FDA's 510(k) clearance for TruDiagnosis multiplex diagnostic system
7 June 2019 -

Molecular diagnostics company Akonni Biosystems Inc reported on Thursday the receipt of the US Food and Drug Administration's (FDA) 510(k) clearance for its TruDiagnosis System.

Through this approval, the company will enter the USD8bn molecular diagnostics market.

The TruDiagnosis System is a compact point-of-service molecular diagnostic device, which includes the TruDx 2000 Imager and the TruArray consumable test kit, both unique and patented technologies. The FDA cleared assay is a non-invasive saliva test that identifies genetic signatures associated with patient metabolization of the drug Coumadin, which will assist doctors in adjusting a patient's therapeutic dose to safer and more effective levels.

"This is an important first step in our goal to bring personalised medicine to the general population at a cost-effective price point without sacrificing diagnostic accuracy and precision," commented Dr Charles Daitch, Akonni CEO.