FDA grants Cepheid marketing clearance for Xpert SA Nasal Complete molecular test

Cepheid (Nasdaq: CPHD) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market Xpert® SA Nasal Complete, the first and only molecular test designed for the simultaneous detection and differentiation of both Staphylococcus aureus (SA) and Methicillin-resistant Staphylococcus aureus (MRSA) colonization in less than one hour. The test runs on Cepheid's GeneXpert® System, the world's leading molecular platform for accuracy, speed, and ease-of-use.

Up to 93% of hospital-acquired SA infections are caused by a patient's own colonized flora, making SA nasal carriers nearly 9 times more likely to develop surgical site infections (SSIs) than non-carriers. Nasal carriage of SA is also a major risk factor for self-infection in dialysis, ICU and burn patients.

"The availability of an accurate and rapid SA/MRSA test should help to improve clinicians' efforts to prevent and control Healthcare Associated Infections (HAIs) identified with colonized patients. HAIs in general are responsible for nearly $30 billion in associated healthcare expenses in the US each year," said John Bishop, Cepheid's Chief Executive Officer. "Surgical, trauma, burn and dialysis patients are most at risk for serious complications from SA infections, which lead to approximately 12,000 inpatient deaths annually in the US."

US hospitals continue to struggle with the rising costs associated with management of HAIs — estimated at $9.5 billion for SA and $20 billion for MRSA annually.(5,6) A recent multicenter study, published in the New England Journal of Medicine, demonstrated that a program employing rapid molecular detection of SA colonization, followed by targeted decolonization, resulted in a 60% reduction in SSIs.

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

Xpert SA Nasal Complete is Cepheid's tenth test to receive FDA clearance, and sixth in its expanding menu of industry-leading HAI products. Xpert SA Nasal Complete will be available for shipment this month.