FDA Clears Test to Detect Bloodstream Infection Bacteria

The agency will allow marketing of the first nucleic acid test that can identify 12 different bacterial types known to cause bloodstream infections. FDA said the test produces results in a few hours after the first sign of bacterial growth.

The U.S. Food and Drug Administration announced it will allow the marketing of the first nucleic acid test that can identify 12 different bacterial types known to cause bloodstream infections. The test can simultaneously identify the bacteria and three associated resistance genes in a few hours after the first sign of bacterial growth, while traditional methods may require 2-4 days, according to the agency.

The Verigene GP Blood Culture Nucleic Acid Test manufactured by Nanosphere Inc. of Northbrook, Ill., can identify different types of Staphylococcus, (including methicillin-resistant Staphylococcus aureus or MRSA), Streptococcus, Enterococcus (including vancomycin-resistant Enterococci or VRE), and Listeria.

"Bloodstream infections are always treated with antimicrobial drugs, and it is essential to identify which antimicrobial drug is appropriate for a specific patient as quickly as possible," said Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at FDA's Center for Devices and Radiological Health. "This new test is an important tool that will help physicians treat patients quickly with the correct antibiotics."

Bloodstream infections are a major issue for U.S. hospitals and a prime focus of their patient safety programs. FDA said its approval is based on a study of 1,642 patient blood samples obtained from incubated blood culture bottles that contained gram positive bacteria. When the test was compared with traditional blood culture lab methods, its results were consistent with traditional blood culture methods in 93 percent to 100 percent of the comparisons, according to the agency."

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    May 2021

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