Drug Topics reports that 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 novo
petition that permits marketing of its Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP), which can identify bacteria including methicillin-resistant Staphylococcus aureus
(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.