Nanosphere has obtained the US Food and Drug Administration's (FDA) 510(k) approval for its infectious C difficile test, designed for use on the sample-to-result Verigene system.
By automating the steps of bacterial DNA extraction, amplification, hybridization, the test detects the toxin A and B gene sequences of C. difficile in less than two hours and identifies the PCR ribotype 027 strain 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 the C. difficile test provides customers with a new tool to fight the deadly and costly infections, including diarrhea 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 company said the C. difficile test complements its 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 commercialize the enteric pathogens and gram-negative tests in 2013, following receipt of the necessary regulatory approvals.