Abbott wins FDA nod for hep C gene test

Abbott's FDA-approved hepatitis C test works with its m2000 analyzers.--Courtesy of Abbott

Abbott Laboratories ($ABT) is all clear to market its RealTime HCV Genotype II test in the U.S., winning the FDA's first-ever approval of a strain-identifying diagnostic for hepatitis C.

The test can discern between 7 genotypes of HCV using an infected patient's blood, allowing physicians to personalize treatment and improve outcomes for the U.S.' nearly 3.2 million sufferers, Abbott said.

As Abbott points out, baby boomers are 5 times more likely to carry the virus than other populations, and last year the Centers for Disease Control and Prevention (CDC) recommended everyone born between 1945 and 1965 get tested for HCV. Abbott's test is designed as a follow-up for those carrying the virus, and the company believes its genotyping technology can help slash the rates of resultant liver cancer, damage and failure.

"When patients are identified, determining their specific genotype is important to ensuring they receive the treatment that will prove to be most effective," the University of California San Francisco's Dr. Carol Brosgart said in a statement. "The introduction of this test for broad use in the U.S. is a significant advancement in helping to address an important public health issue."

RealTime HCV Genotype II works with Abbott's m2000 molecular diagnostic system, which boasts assays for HPV, herpes and other viruses.

Now that Abbott has entered its post-pharma era, diagnostics revenue is of increasing importance. While aging stents and pricing pressures have dragged down Abbott's medical device sales, the company's diagnostics segment grew 4.4% to $1.1 billion last quarter, fueled by a 3.6% jump in the core lab unit and a 17.3% leap in Abbott's small but fast-growing point-of-care business.

- read Abbott's announcement
- check out the FDA's release