(Submitted to FDA – in regulatory clearance process)
Disease Background: Valley Fever is a fungal infection that is endemic in the United States desert southwest, primarily the Phoenix-Tucson corridor and the San Joaquin Valley in California. Pockets of disease are also found in Nevada, New Mexico, southwest Texas and Washington. Coccidioidomycosis most commonly causes a progressive pulmonary infection in humans and other vertebrate hosts but also can disseminate to other body parts including the skin, brain, bone, and meninges when diagnosis and treatment are delayed. This disseminated secondary coccidioidomycosis is often severe and can even result in death or prolonged or life-long treatment programs. However, in cases where infection is resolved, patients usually acquire a specific and lifelong immunity to the fungus.
In Arizona alone there are an estimated 150,000 infections annually resulting in 1,735 hospitalizations. Hospitalization costs alone total $86,000,000 (or $50,000 per hospitalization) These high costs are driven to a significant degree by the high level of misdiagnosis resulting in an average time to diagnosis of 5 months from when a patient first seeks care. Individuals who travel from non-endemic areas and spend winters in the endemic areas are also at risk for Valley Fever.
Valley Fever Test: The Valley Fever test is a molecular diagnostic test for the detection of the fungus responsible for coccidioidomycosis. The assay is a real-time PCR single target assay. The assay uses a target that identifies both strains of Coccidioides: Coccidioides immitus and Coccidioides posadasii which are found in the endemic areas. The proprietary target used in the assay was selected as it is highly repeated in the Coccidioides genome making it ideal for optimizing the sensitivity of the assay (i.e. its ability to detect a sample containing Coccidiodes). The result will be reported as positive or negative for coccidioides in the specimen. The test has been developed and tested for use with deep respiratory specimens collected as Bronchoalveolar Lavage (BAL) and Bronchial Washings, as these are the specimen collection methods typically used on presentation of a patient with symptoms. The assay provides definitive results in 60 minutes, dramatically improving the diagnosis of the disease over current methodologies, both in terms of time and accuracy.
The intellectual property (IP) used in the Valley Fever Test is exclusive to DxNA LLC and covers both human and veterinary applications.
The Coccidiomycosis (Valley Fever) Test for human diagnostics is projected to be commercially available in Q4-2017.