Cepheid announced it has received clearance from the FDA to market Xpert® SA Nasal Complete, a 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.1,2 Nasal carriage of SA is also a major risk factor for self-infection in dialysis, ICU and burn patients.2,3,4

"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."1

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.7

"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."

Source: Cepheid

References:

1. Critchley et al, Drug Discovery Today, 2006, Vol. 3 No. 2
2. VL Yu et al., "Staphylococcus aureus nasal carriage and infection in
     patients on hemodialysis.  Efficacy of antibiotic prophylaxis."  NEJM
     July 1986
3. Mackie et al,  "Reduction in Staphylococcus aureus wound
     colonization.", Burns 1994; 20, (1), S14-S18
4. Kooistra-Smid et al, "Molecular epidemiology of Staphylococcus aureus
     colonization in a burn center", Burns 2004, Feb; 30 (1), 27-33
5. Noskin, Infection Control Hospital Epidemiology, 2008, Vol. 29, No. 1
6. Saadatian-Eliahi et al, International Journal of Surgery, 2007, Vol. 6,
     Issue 3
7. Bode et al, "Preventing Surgical-Site Infections in Nasal Carriers of
     Staphylococcus aureus", NEJM January 2010