Cepheid, a molecular diagnostics company, has received the US Food and Drug Administration (FDA) approval to market its Xpert Clostridium difficile/Epi test to identify epidemic 027 strain.
The Xpert C. difficile/Epi test, which runs on the GeneXpert system, is Cepheid’s 10th Xpert test to receive FDA clearance.
Building on the success of Xpert C. difficile, which detects the bacterium that causes C. difficile infection (CDI), Xpert C. difficile/Epi additionally and simultaneously identifies the epidemic strain of C. difficile, also known as 027, NAP1 or BI.
Although the Xpert C. difficile/Epi test is not intended to guide specific patient treatment decisions, it will identify those patients infected with the epidemic strain and therefore at greater risk.
Cepheid chief medical and technology officer David Persing said the use of Cepheid’s special nucleic acid chemistry capability was critical to achieve the required performance levels of sophisticated next-generation test, which targets two toxin genes and a regulatory point mutation.
The test is expected to be available for shipment from 16 May.