June 9, 2010

Cepheid (NASDAQ: CPHD) of Sunnyvale has received approval from the U.S. Food and Drug Administration for a test that can simultaneously detect two types of staph infections, including the multi-drug-resistant Staphylococcus aureus, or MRSA, in less than an hour.

Healthcare Associated Infections (HAIs) in hospitals are a large problem accounting for almost $30 billion annually in healthcare costs nationwide, said John Bishop, Cepheid’s CEO in a press release.

The molecular diagnostics company hopes this new product called Xpert SA Nasal Complete will help identify and prevent both Staphylococcus aureus (SA) and Methicillin-resistent Staphylococcus aureus (MRSA).

Cepheid reported that up to 93 percent of patients who get an SA infection in the hospital get it as a result of their own colonized flora. And they are nine times more likely to get a surgical site infection. Those who carry SA in their nasal passages are at major risk for infection if they are dialysis, ICU or burn patients. SA infections cause about 12,000 inpatient deaths a year in this country, Cepheid reported.

The company cited a new study published in the New England Journal of Medicine showing that using rapid molecular detection of SA colonization and then decolonization procedures could reduce surgery site infections by 60 percent.

“A rapid test for both SA and MRSA will have many applications for patients at risk of colonization,” said Samir S. Awad, M.D., Associate Professor of Surgery and Chief of the Section of Critical Care at Baylor College of Medicine in a press release. “Those applications include assisting physicians in targeting appropriate prophylactic therapy and decolonization to reduce the risk of post surgical site infections,” he said.

This is Cepheid’s tenth product to receive FDA approval. It now has six HAI products. The company’s stock has ranged between $8.26 and $21.02 over the last 52 weeks. It closed today at $16.87.