FDA Approves Abbott's HBV MDx Test | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Abbott today announced it has received approval from the US Food and Drug Administration to market the Abbott RealTime HBV assay for measuring the viral load of hepatitis B in patients.

The test is the first automated molecular test for assessing HBV viral load to receive FDA approval, Abbott said.

Other molecular HBV tests that aren't automated that have received FDA approval include Roche's Cobas TaqMan HBV Test and Gen-Probe's Procleix Ultrio assay.

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