Research & Development
Cepheid announces US FDA's clearance for expanded claims for Xpert Carba-R molecular test
16 May 2018 -

Diagnostics company Cepheid disclosed on Tuesday the receipt of clearance from the US Food and Drug Administration (FDA) for expanded claims for the 'super bug' Xpert Carba-R molecular test to aid clinicians in determining appropriate therapeutic strategy for pure colony specimens.

The company said the Xpert Carba-R is an on-demand molecular test for rapid and accurate detection of carbapenemase-producing gram-negative bacteria primarily responsible for the increasing spread of Carbapenem-resistant Enterobacteriaceae (CRE) infection in the US.

In addition, the additional claims extend use to analysis of perirectal swab specimens and allow use of Xpert Carba-R test results to guide therapeutic strategies for pure colonies, according to the company.

Detection and differentiation of high-risk patients with Xpert Carba-R can alert clinicians and infection preventionists quickly to the presence of gene sequences associated with carbapenem non-susceptibility in gram-negative bacteria, including Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii, concluded the company.

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