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Medical Devices / Submissions and Approvals

FDA Permits Marketing of Phenotest BC Kit to Identify Organisms That Cause Bloodstream Infections

Feb. 27, 2017

The FDA has allowed the marketing of the PhenoTest BC Kit to identify organisms that cause bloodstream infections and provide information about which antibiotics the organism is likely to respond to.

The test can identify 14 different species of bacteria and two species of yeast that cause bloodstream infections, while also providing antibiotic sensitivity information on 18 selected antibiotics for a subset of the identified organisms as appropriate.

The test will also identify the presence of two indicators of antibiotic resistance, which can occur when potentially harmful bacteria change in a way that reduces or eliminates the effectiveness of antibiotics.

The FDA’s decision to allow marketing was based largely on its review of the sponsor’s primary clinical study. In this study, the PhenoTest BC Kit provided correct identification of the bacteria or yeast in the positive blood culture more than 95 percent of the time. — Cynthia Jessup

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