FDA has cleared Cepheid's Xpert SA Nasal Complete, a molecular test designed for the detection and differentiation of both Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) colonization.
California-based Cepheid is a molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests for genetic analysis in the clinical, industrial and biothreat markets.
The Xpert SA Nasal Complete test runs on Cepheid’s molecular platform GeneXpert System. Cepheid said that the system is a closed, self-contained, fully-integrated and automated platform that produces accurate results in a timely manner with minimal risk of contamination.
Cepheid added that the test is its tenth test to receive FDA clearance, and sixth in its expanding menu of HAI products. The test is expected to be available for shipment in the current month.
John Bishop, chief executive officer of Cepheid, said: “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 $30bn in associated healthcare expenses in the US each year.”
Samir Awad, associate professor of surgery, chief, section of critical care at Baylor College of Medicine, said: “A rapid test for both SA and MRSA will have many applications for patients at risk of colonization. Those applications include assisting physicians in targeting appropriate prophylactic therapy and decolonization to reduce the risk of post-surgical site infections.”