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Included in the 510(k) clearances was one for AMS Diagnostics' Liasys 600 Electrolyte Measurement System for measuring sodium, chloride, and potassium in human serum.
The Frederick, Maryland-based firm has received regulatory clearance for a multiplexed array-based assay after more than 15 years in development.
Akonni has received clearance for a molecular diagnostic instrument and a saliva-based pharmacogenomics test for warfarin metabolism.
The device can process high-volume sputum samples for PCR-based Mycobacterium tuberculosis detection at smear-negative, culture-positive levels.
Upon clearance of the platform, the company will commercialize the TruDiagnosis, an IVD system for genotyping multiple genes in a DNA sample, this year.
The firm plans to make the molecular testing system accessible to low-income countries, in part by reducing costs using reel-to-reel manufacturing.
The exclusive two-way licensing deal also allows Akonni to commercialize Righton's molecular diagnostic tests outside of China.
The grant was awarded under a program designed to help small businesses transition NIH-funded projects into the commercialization stage.
The grant is specifically intended to support the development of noninvasive, rapid tests that can be used at the point of care in developing country settings.
The funding will be used in part to prepare an FDA submission for a clinical IVD pharmacogenomic test for its TruDx 2000 microarray platform.