FDA has approved the marketing of the first nucleic acid test that can identify in less than 3 hours 12 different bacterial types known to cause bloodstream infections.
FDA has approved the marketing of the first nucleic acid test that can identify 12 different bacterial types known to cause bloodstream infections. The test allows for simultaneous identification of the bacteria and three associated resistance genes in just a few hours after the first sign of bacterial growth.
Device manufacturer Nanosphere was granted a de novopetition that permits marketing of its Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP), which can identify 12 different types of bacteria, including methicillin-resistant Staphylococcus aureus, Enterococcus (including vancomycin-resistant Enterococci), and Listeria, in less than 2.5 hours. Traditional methods may require 2 to 4 days to produce bacterial identification and resistance results.
The company reports that studies demonstrated delayed antibiotic treatment is associated with a 7.6% decrease in survival rate for each hour therapy is delayed; therefore, the quick and accurate molecular test may save hospitals up to $21,000 per patient.
"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."
FDA based its decision on a study in which blood samples cultured from bottles containing gram-positive bacteria were obtained from 1,642 patients. Investigators compared BC-GP and traditional blood culture laboratory methods and found that the BC-GP results were consistent with traditional blood culture methods in 93% to 100% of the comparisons.