Cepheid receives FDA approval for expanded claims on Xpert MTB/RIF test

Molecular diagnostics firm Cepheid has received approval from the US Food & Drug Administration (FDA) for expanded claims on its Xpert MTB/RIF test.

The expanded product claim will allow clinicians to use either one or two negative Xpert MTB/RIF test results, in conjunction with other clinical and laboratory data, to remove patients from airborne infection isolation (AII), commonly referred to as respiratory isolation.

Cepheid chairman and CEO John Bishop said: "Xpert MTB/RIF has been heralded as a game-changer with its ability to deliver actionable results in under two hours.

"This claim expansion significantly extends the diagnostic utility of Xpert MTB/RIF for US hospitals."

Xpert MTB/RIF is said to detect Mycobacterium tuberculosis complex (MTB-complex) DNA, and help in simultaneous identification of rifampin-resistance associated mutations of the rpoB gene in positive specimens.

The test is being carried on the Cepheid GeneXpert System, a molecular diagnostic platform with around 8,000 systems deployed across the globe.

Cepheid chief medical and technology officer Dr David Persing said: "Although the incidence of tuberculosis in the U.S. is low, due in large part to successful public health strategies, the number of patients being evaluated for possible tuberculosis is still significant."