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FDA-Cleared Valley Fever

A Better Test for the Valley Fever (Coccidioidomycosis) Endemic

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 can also disseminate to other parts of the body including the skin, brain, bone, and meninges when diagnosis and treatment are delayed. This disseminated secondarycoccidioidomycosis 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.

The High Cost of Valley Fever

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 along with the associated cost burden. 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
  • Multiple courses of ineffective antibiotics 
  • Treatment antifungals after antibiotics aren’t effective

Each uncomplicated Valley Fever Pneumonia case costs over $22,000 in total care, for an annual expenditure in California of $139M.

The Need for Better Testing

Currently available methods for Valley Fever diagnosis have significant shortcomings relative to accuracy and timeliness. These shortcomings lead tomissed diagnosis or misdiagnosis, resulting in ineffective treatment and increased morbidity and mortality. 

Currently, definitive testing forCoccidioidomycosisis done by culture to grow the fungus in a Biosafety Level 3 laboratory. This is time consuming — requiring up to 21 days — and exposes laboratory personnel to the highly infectious fungus. The GeneSTAT.MDxCoccidioides test represents a significant improvement in time-to-results over current diagnostic methods. By contrast, our highly sensitive, specific, and reproducible GeneSTAT test is performed directly on the patient specimen, providing a same-day result and significantly reducing the time required to achieve a definitive diagnosis and appropriate care.

Clear-Cut Answers at the Point of Need

The GeneSTAT.MDxCoccidioides test on the GeneSTAT System is intended to provide adefinitive diagnosis at the point of care for bothCoccidioides strains(C. immitis andC. posadasii) causingCoccidioidomycosis (Valley Fever). 

This FDA-cleared test provides for the availability of molecular testing for Valley Fever 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.

The FDA-cleared GeneSTAT.MDxCoccidioides (Valley Fever) test on the GeneSTAT® system addresses the unmet need for a rapid and definitive molecular diagnostic test to aid in the accurate, on-site diagnosis ofCoccidioidomycosis

Test Cartridge

The novel, patented GeneSTAT test cartridge is a single-use cartridge that contains all reagents needed along with all of the information required to perform a specific test. The present cartridge has the capacity for up to four results with 3 analytical targets plus 1 control.  

The reagents are lyophilized (freeze dried) in each of the reaction wells, providing for reagent stability up to 18 months at ambient storage conditions. Once the specimen is placed into the cartridge, the cartridge becomes a closed, pressurized system. This eliminates issues that can arise due to differences in ambient conditions or contamination from PCR products produced in the test process. 

All information required by the instrument to run a particular test is contained on an RFID tag located on each cartridge.  The operator only has to press “run” on the instrument or the attached computer after placing the cartridge into the instrument to initiate the specimen transfer to the reaction wells and the PCR reactions. The RFID tag also prevents cartridges from accidentally being reused as the instrument writes back to the tag once a testing run has been completed.