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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