FDA clears Akonni's test for warfarin genotyping

2019 05 10 17 42 3167 Lab Doctors Dna 400

Akonni Biosystems is set to introduce a new noninvasive saliva test designed to help doctors decide which patients to send on for blood thinner therapy with warfarin after the product was cleared by the U.S. Food and Drug Administration (FDA).

Akonni's TruDiagnosis system is designed to detect genetic deficiencies in the cytochrome P450 enzyme CYP2C9, which is important for metabolizing warfarin. The company announced the clearance of TruDiagnosis on June 6.

TruDiagnosis includes the TruDx 2000 imager and TruArray consumable test kit and received 510(k) clearance on May 24 for DNA genotyping of clinical samples. In its statement about the clearance, Akonni said it wants to work with partners to build their own diagnostic assays -- laboratory-developed tests and research-use-only units -- with its TruArray consumable device. The company is also working to expand its own menu of assays that may be used with the system.

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