Akonni
Akonni Biosystems Developing Multi-Target Infectious Diseases Tests for Newly Cleared TruDx System
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The Frederick, Maryland-based firm has received regulatory clearance for a multiplexed array-based assay after more than 15 years in development.
Akonni Bio Obtains FDA 510(k) Clearance for TruDiagnosis MDx System, PGx Test
Akonni has received clearance for a molecular diagnostic instrument and a saliva-based pharmacogenomics test for warfarin metabolism.
Akonni Wins $3M NIH Contract to Develop TB Sample Prep Device
The device can process high-volume sputum samples for PCR-based Mycobacterium tuberculosis detection at smear-negative, culture-positive levels.
Akonni Biosystems Submits Multiplex Diagnostics System to FDA
Upon clearance of the platform, the company will commercialize the TruDiagnosis, an IVD system for genotyping multiple genes in a DNA sample, this year.
Akonni Biosystems Scores $3M NIH Grant for POC Dx Platform, Drug-Resistant TB Assay
The firm plans to make the molecular testing system accessible to low-income countries, in part by reducing costs using reel-to-reel manufacturing.