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Cepheid Gets CE Mark for Drug-Resistant Bacteria Dx; Partners with Pharma for US Development

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This article has been updated from a previous version to include information about Cepheid's pharmaceutical partnerships around the Xpert Carba-R assay.

NEW YORK (GenomeWeb) — Cepheid this week announced the European release of a new on-demand molecular diagnostic designed to test for multi-drug resistant pathogens, and said that it is collaborating with three US pharmaceutical partners to further develop the assay to help physicians prescribe the most beneficial antibiotics for patients.

The test, called Xpert Carba-R, detects carbapenemase-producing Gram-negative bacteria in about one hour and runs on Cepheid's real-time PCR-based GeneXpert System. Cepheid said in a statement that the test will begin shipping this month in Europe as a CE-marked in vitro diagnostic.

Carbapenemase-producing bacteria break down carbapenem antibiotics, drugs considered to be "the last line of defense in our medical toolbox," said Cepheid CEO John Bishop. Quickly detecting these multidrug-resistant organisms may help healthcare institutions prevent widespread outbreaks.

Xpert Carba-R detects genes encoding the most prevalent carbapenemases, discriminating amongst five families comprising 68 known resistance genes.

Carbapenemase-producing organisms include the gut microbes Klebsiella pneumoniae and Escherichia coli, as well as the hospital-associated bacteria Pseudomonas aeruginosa and Acinetobacter baumannii. Stopping spread of these drug-resistant pathogens is important, in part because carbapenemase-encoding genes can be transferred between bacteria.

Following its announcement of the European launch of the test, Cepheid said that it is collaborating with AstraZeneca, Cubist Pharmaceuticals, and GlaxoSmithKline to further develop the test for the US market. In particular, the test currently assesses bacteria from rectal swab samples, and the goal of the partnership is to enable the test to analyze a variety of other biological specimens, such as respiratory samples from pneumonia patients.

"To make sure we do not go back to the pre-antibiotic era where simple infections were very dangerous and many current hospital procedures and treatments would be impossible, we need to more effectively use the antimicrobials we have and we need to develop new medicines," Linda Miller, director of diagnostics and clinical microbiology for GSK's antibacterial R&D, said in a statement. "Accurate, rapid, easy to use diagnostic tests that can identify infecting pathogens directly from a patient sample will alter the way we treat bacterial infections by allowing us to enhance the efficiency of clinical trials and provide physicians with test results prior to making critical treatment decisions."

Cepheid said it is targeting a 2015 US launch for the test, following regulatory approval.

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