Nanosphere, Inc. announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance permitting marketing of its C.difficile test on the automated sample-to-result Verigene® System.
The C. difficile test expands Nanosphere’s infectious disease test capabilities. C. difficile infection is a cause of diarrhea that can lead to colitis, other serious intestinal conditions and death. In less than two hours, the C. difficile test detects the toxin A and B gene sequences of C. difficile and identifies the PCR ribotype 027 strain which is associated with increased severity of disease and used for infection control. Early and accurate diagnosis of C. difficile infections is critical in both the proper treatment of infected patients and subsequent implementation of isolation and containment procedures to prevent further spread of the infection.
“The C. difficile test provides Nanosphere’s customers with a valuable tool to fight these deadly and costly infections,” said Bill Moffitt, Nanosphere’s Chief Executive Officer. “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 sample-to-result test automates the steps of bacterial DNA extraction, amplification, hybridization and target detection on the Verigene System. The ease-of-use and rapid turnaround time of the test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing.
The C. difficile test complements Nanosphere’s broadening menu of infectious disease tests including:
• Gram-Positive Blood Culture test (BC-GP) to detect bacteria, including antibiotic resistance markers, that may cause bloodstream infections (510(k) cleared; CE-Mark)
• Respiratory Virus Plus test (RV+) to detect multiple respiratory viruses which cause respiratory tract infections (510(k) cleared; CE-Mark)
• Enteric Pathogens test (EP) to detect and multiple bacteria, viruses and toxin genes which cause gastrointestinal infections (In Clinical Trials )
• Gram-Negative Blood Culture test (BC-GN) to detect bacteria, including antibiotic resistance markers, that may cause bloodstream infections (In Clinical Trials)
Nanosphere plans to commercialize the enteric pathogens and gram-negative tests in 2013 following receipt of the necessary regulatory approvals.
About C. difficile Infections
C. difficile strikes nearly 500,000 Americans annually and is linked in hospital records to more than 30,000 deaths per year in the United States. The elderly, immunocompromised, and those recently treated with antibiotics have the greatest risk of acquiring C. difficile infections. Around 75% of C. difficile infections are acquired in hospitals or nursing homes, with transmission to patients occurring via the hands of healthcare workers or contact with contaminated surfaces2. Community-acquired cases of C. difficile, however, are on the rise. The increase in severity of C. difficile infections over the past decade is likely linked to the emergence of the BI/NAP1/027 hypervirulent strain, with C. difficile related deaths increasing 400% over that timespan. “Hospital billing data collected by the Federal Agency for Healthcare Research and Quality shows that more than 9% of C. diff-related hospitalizations end in death — nearly five times the rate for other hospital stays,” according to a recent USA TODAY investigation1. Currently, the federal government does not have a system in place to track antibiotic use in healthcare facilities, and there is no Medicare and Medicaid penalty for facilities with high C. difficile rates. A new C. difficile reporting rule is scheduled to be implemented in 2013 that will now include reporting in nursing homes and rehabilitation centers in addition to hospitals in attempts to combat C. difficile spread.