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FDA Approves Abbott's HBV MDx Test

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.

Abbott's PCR-based test was developed on its m2000 system and is now available to all labs that use the system. The assay was initially introduced in Europe and elsewhere in 2007. It measures all known HBV genotypes by targeting an "essential, highly conserved segment of the HBV genome," the company said in a statement, adding that that ability is crucial for both monitoring the disease and making treatment decisions.

The test also offers a broad dynamic range and can quantitate levels between about 10 IU/mL and 1 billion IU/mL in a patient's blood, enabling physicians to assess patient response to treatment.

The HBV test is intended as an aid in managing patients with chronic HBV infection undergoing anti-viral treatment and is not to be used as a screen for the virus or as a diagnostic tool for confirming the presence of HBV.

It can be used to measure HBV DNA levels at baseline and during treatment in order to evaluate treatment response, Abbott said. Results "must be interpreted within the context of all relevant clinical and lab findings. Use of the assay to determine the clinical stage of HBV infection has not been established," it added.

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