Roche wins FDA nod for hep C diagnostic

Roche won FDA approval for a new hepatitis C diagnostic.--Courtesy of Roche

Roche ($RHHBY) has secured the FDA's blessing for a new viral load hepatitis C test, designed to gauge a patient's response to treatment by identifying the virus' RNA levels.

The assay, designed for Roche's Cobas platform, is intended to help patients with chronic hepatitis C manage the virus, giving physicians valuable feedback to guide future treatments. The kit is an in vitro nucleic acid amplification test that can predict viral response to treatment, making it an excellent tool for personalized medicine, Roche Diagnostics COO Roland Diggelmann said.

"The rapidly changing hepatitis C treatment landscape requires tests with an additional layer of protection in detecting and accurately quantifying hepatitis C RNA across genotypes," Diggelmann said in a statement. "This test can play a valuable role in response-guided therapy, helping physicians and patients better manage the disease and optimize treatment choices and duration."

Hepatitis C affects about 200 million people around the globe, according to the World Health Organization, and coupling treatment with a viral load diagnostic can help improve the efficacy of therapies for the virus, Roche says, allowing doctors to tailor drug regimens to a patient's specific infection.

Launching the test in the U.S. will bolster Roche's up-and-coming molecular diagnostics division, which grew 7% to $1.3 billion in sales last year. Professional diagnostics remains the drugmaker's largest Dx unit, grossing $5.6 billion in 2012, a 10% leap over the previous year.

- read Roche's statement

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