GeneSTATMolecularDiagnostics,LLC 435-635-5553

Coccidioidomycosis (Valley Fever)

Disease Background: 

Valley Fever (Coccidioidomycosis) is a fungal infection that is a recognized public health problem endemic in the desert southwest United States, primarily the Phoenix-Tucson corridor in Arizona and the San Joaquin Valley in California.  Pockets of disease are also found in Nevada, New Mexico, Utah, 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.

In California Valley Fever cases are on the rise and its cost burden in California.  Based on current California practice, Valley Fever associated pneumonia diagnosis, for 85% of patients with pneumonia symptoms, involved an estimated three medical care visits including emergency department visits and hospitalization. The standard diagnosis practice includes x-rays, multiple serology tests and multiple courses of ineffective antibiotics before treatment with antifungals. Each uncomplicated Valley Fever Pneumonia case costs over $22,000 in total care for an annual expenditure in California of $139M

Valley Fever Test:

Currently available methods for diagnosis have significant shortcomings relative to accuracy and timeliness. These shortcomings lead to missed diagnosis or misdiagnosis resulting in ineffective treatment and increased morbidity and mortality. The Company’s FDA-cleared GeneSTAT.MDx Coccidioides  (Valley Fever) test on the GeneSTAT system addresses the unmet need for a rapid and definitive molecular diagnostic test to aid in the accurate diagnosis of coccidioidomycosis.

The GeneSTAT.MDx Coccidioides test on the GeneSTAT System is intended to provide a definitive diagnosis for both Coccidioides strains (C. immitis and C. posadasii) causing Coccidioidomycosis (Valley Fever). The GMD test significantly improves the time to results over current diagnostic methods. The cleared test provides for the availability of molecular testing for the disease at clinical laboratories and healthcare facilities where patients with the disease are primarily seen rather than requiring specimens to be sent to reference laboratories.

The high performance Valley Fever test on the GeneSTAT System was developed based on intellectual property exclusively licensed from the Translational Genomics Research Institute (TGen) and Northern Arizona University (NAU) in Flagstaff, Arizona.

Currently, definitive testing is done by culture to grow the fungus in a Biosafety Level 3 laboratory, which is time consuming, up to 21 days, and exposes laboratory personnel to the highly infectious fungus. The highly sensitive, specific and reproducible GeneSTAT test is performed directly on the patient specimen, providing a same-day result and significantly reducing the time to a definitive diagnosis and appropriate care.