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, 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.