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Healthcare

U.S. OKs Cepheid test for drug-resistant infection

(Adds company comment, background, byline)

WASHINGTON, Sept 29 (Reuters) - U.S. regulators have approved Cepheid's CPHD.O test to rapidly screen for drug-resistant bacterial infections in less than one hour, the company said on Monday.

The test, called Xpert, aims to detect infections of staphylococcus aureus in skin and soft tissue, including those resistant to antibiotic drugs, in less than one hour.

Current lab tests take between 48 and 72 hours to make a diagnosis, forcing doctors to prescribe strong antibiotics until they have more information, according to the Sunnyvale, California-based diagnostics company.

“The ability to detect MRSA (Methicillin-resistant Staphylococcus aureus) or SA (Staphylococcus aureus) in less than one hour, versus two to three days with current culture methods, will enable clinicians to make real-time decisions as to the best course of treatment or management,” Cepheid Chief Executive John Bishop said.

Cepheid’s test was designed to be used with the company’s GeneXpert System in hospitals, doctor’s offices and other testing locations.

Most experts agree that unnecessary use of powerful antibiotics causes bacteria to develop resistance to the drugs.

So-called staph infections have become a growing concern, with more than half now resistant to antibiotic therapy, according to the U.S. Centers for Disease Control and Prevention.

When treatments fail, patients may face longer hospital stays, several rounds of different and possibly toxic drugs, surgery or even death.

More than 94,000 life-threatening infections and nearly 19,000 deaths in the United States in 2005 have been linked to resistant staph infections, the CDC has said.

Costs are also a concern, with subsequent drugs and longer hospital stays ratcheting up bills for patients and insurers. (Editing by Steve Orlofsky)

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