Great Basin’s first commercialized molecular diagnostics test is the Portrait Toxigenic C. difficile Assay. This assay has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is available as a European CE-IVD product under the European Directive 98/79/EC on In Vitro Diagnostic Medical Devices.
Great Basin’s easy-to-use integrated cartridge system offers ease-of-use and cost savings with information-rich detection of infectious diseases, allowing providers to diagnose and define a clear treatment path sooner for improved patient outcomes.
Great Basin is exploring the development of a test that can identify hypervirulent strains of toxigenic C. difficile.
For more information on the Portrait Toxigenic C. difficile Assay or to purchase our system, please Contact Great Basin Sales
About Clostridium difficile (C. diff)
Toxigenic C. difficile is the main etiological agent of antibiotic associated diarrhea (15-25% of cases) and pseudomembranous colitis. Clostridium difficile infection (or CDI), is caused by use of antibiotics which disrupt normal intestinal flora, predisposing patients to colonization by C. diff. Toxigenic C. difficile is a spore-forming, gram positive anaerobic bacillus that can product two toxins: Toxin A (tcdA gene) and Toxin B (tcdB gene). Pathogenicity is conferred by the toxins; non-toxigenic strains do not cause disease.
Early recognition of CDI is critical for proper disease management. The prevalence of the disease is growing as is the mortality rate; the number of C. diff outbreaks has risen markedly since 2003, according to the Association for Professionals in Infection Control and Epidemiology. Accurate and rapid diagnosis of Clostridium difficile infection (or CDI) is essential to aid in therapy selection and improvepatient outcome, prevent disease spread and lessen negative impacts on healthcare systems:
- CDI accounts for increased length of stay of 5.6 days
- Incremental cost of CDI infection is estimated at $7,179
- CDI affects 13 per 1,000 admitted patients in the US, and 11 per 1,000 patients in Europe