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Akonni Bio Obtains FDA 510(k) Clearance for TruDiagnosis MDx System, PGx Test

NEW YORK (GenomeWeb) – Akonni Biosystems announced today it has received FDA 510(k) clearance for its TruDiagnosis molecular diagnostics system and a pharmacogenomics assay to identify genetic signatures associated with metabolism of the blood thinner warfarin (Coumadin). 

The TruDiagnosis system, which was submitted to the FDA earlier this year, is a compact device that can be used in a near-patient manner. The system includes the firm's TruDx 2000 Imager and a consumable test kit called TruArray, and it runs on-chip PCR with non-contact detection by piezo-electric printed microarray microsensors within the same chamber.

The TruArray test kit cleared by the FDA uses saliva samples to help physicians adjust doses of the warfarin based on a patient's ability to metabolize the drug. According to the firm's website, the TruArray Warfarin Assay detects and genotypes SNPs in the CYP2C9 gene of the cytochrome P450 enzyme and vitamin K epoxide reductase C1 (VKORC1) gene promoter, with a sample-to-result time of less than three hours. 

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

The Frederick, Maryland-based firm plans to further develop assays for the system to be used in oncology, cardiology, infectious disease, and pharmacology testing, in part through partnerships. 

Partners can potentially adapt their internal laboratory-developed tests or research-use-only assays for use on the TruArray consumable device, which has a "much faster workflow and a cost-effective consumable for multiplexed genotyping as compared to traditional microarray or sequencing-based technologies," Daitch said.