The US Food and Drug Administration (FDA) has granted 510(k) approval to Nanosphere‘s infectious C difficile test for use on the sample-to-result Verigene system.
By automating the steps of bacterial DNA extraction, amplification and hybridisation, the test detects the toxin A and B gene sequences of C. difficile in less than two hours.
The test also identifies the PCR ribotype 027 strain, which is associated with increased severity of disease and used for infection control.
Early detection of C. difficile can help clinicians to provide proper treatment to infected patients and subsequently implement the isolation and containment procedures to prevent further spread of the infection.
Nanosphere chief executive officer Bill Moffitt said that the C. difficile test provides customers with a new tool to fight deadly and costly infections, including diarrhoea and serious intestinal conditions.
"With four new products cleared by the FDA in the last 12 months, we are pleased to lead the market in providing a comprehensive suite of tests that can improve patient outcomes and reduce healthcare spending," Moffitt stated.
The C. difficile test complements Nanosphere’s Gram-Positive Blood Culture test (BC-GP), Respiratory Virus Plus test (RV+), Enteric Pathogens test (EP) and Gram-Negative Blood Culture test (BC-GN).
Nanosphere is planning to commercialise the enteric pathogens and gram-negative tests in 2013, following the receipt of the necessary regulatory approvals.