SelectScience
Join Free
Accelerating Science
NewsClinical Diagnostics

Nanosphere Receives FDA Clearance for C. difficile Test

Nanosphere
12 Dec 2012

Product news

Nanosphere, Inc., a leader in the development and commercialization of advanced molecular diagnostics systems, has announced 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.

Links

NanosphereCompany website

Tags

Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Clostridium difficileIn Vitro DiagnosticsIn vitro diagnostics (IVD) involve testing samples outside the body, typically in a laboratory, to diagnose diseases or conditions. IVD technologies include blood tests, molecular assays, and other bodily fluid tests, enabling accurate diagnosis and monitoring of diseases. These tests are essential for guiding treatment decisions in clinical settings. Browse our peer-reviewed product directory to find the best IVD solutions; compare products, check reviews, and get pricing directly from manufacturers.Bacterial DetectionBacterial detection uses methods such as cell culture, microscopy, and biochemical assays to identify harmful or beneficial bacteria based on their morphological and metabolic charactersistics. These techniques support disease diagnostics, food safety, and microbial research. Explore bacterial detection systems, kits, and consumables in our directory to compare products and read reviews.Infectious DiseasesInfectious diseases are caused by pathogens such as bacteria, viruses, and fungi. Effective detection, prevention, and treatment are crucial to control outbreaks and improve public health. Diagnostic tools, vaccines, and antimicrobial treatments are essential components of managing these diseases. Research into emerging pathogens and resistance patterns continues to evolve. Browse our peer-reviewed product directory to find the best diagnostic tools, prevention solutions, and treatment options; compare products, read customer reviews, and get pricing directly from manufacturers.

Related articles

Nanosphere Receives FDA Clearance for C. difficile Test