Cryptococcosis is a fungal infection that produces a fatal meningitis in patients with immune deficiencies. Cryptococcosis is produced by two species of yeast: Cryptococcus neoformans and Cryptococcus gattii. C. gattii is currently producing an unprecedented outbreak in the Pacific Northwest that began in Vancouver Island, BC and is spreading down the Pacific coast in the United States. Differentiation between C. neoformans and C. gattii is clinically important because infection by C. gattii requires a much more aggressive approach to patient management.
Currently, there is little that can be done to distinguish infection by C. neoformans from C. gattii in the course of patient care. Available technologies require isolation of the yeast and use of special culture media or use of examination of DNA. These take days to a result, require highly trained personnel and are expensive.
The approach used by DxDiscovery is detection of a biomarker in blood that can distinguish infection by C. neoformans from infection by C. gattii. The diagnostic platform will be the lateral flow immunoassay. The test will provide results within 10 minutes without the need for specialized equipment or highly trained personnel. This is a diagnostic that can save lives through more effective patient management.
The potential market is any patient who presents with symptoms of meningitis. In addition, approximately 2-3% of all AIDS patients worldwide have infection by C. neoformans or C. gattii. The ability to rapidly make a diagnosis with a serum sample instead of cerebral spinal fluid will greatly reduce barriers to testing and promote product use.
Much of the intellectual property for development of a cryptococcal speciation diagnostic was generated by 31 years of NIH support to T. Kozel. A STTR proposal to the National Institute for Allergy and Infectious Diseases for further R&D is pending. This proposal would provide an R&D budget of almost $600,000 over two years.
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