GenestatMolecularDiagnostics,LLC435-635-5553info@genestatmdx.com

Valley Fever

Know Today If It’s Valley Fever

FDA-Cleared One-day Test Can Be Done On-Site or in a Regional Lab

Under current methods, the average time to definitively diagnose Coccidioidomycosis is about 5 months from when a patient first seeks care. With the GeneSTAT.MDx CoccidioidesAssay, a confident diagnosis can be made in one day.

Current Testing vs. GeneSTAT Disagnostics

Definitive Diagnosis
Direct Health Care Costs
Patient Health Impact
Physician Experience
5 months
$22k - $50k
Uncertain results
Chronic diagnosis with lifetime cost
Same day
~$5,000
Full recovery more likely
Definitive answer

Definitive testing for Coccidioidomycosis has traditionally been done by culture to grow the fungus in a Biosafety Level 3 laboratory. This is time consuming — with culture alone requiring up to 21 days. The GeneSTAT.MDx Coccidioides Assay is highly sensitive, specific, and reproducible. Our test is performed directly on the patient specimen, without need for culture, providing a same-day, definitive result so appropriate care can begin right away.

The standard process for Valley Fever diagnosis has significant shortcomings that may lead tomissed diagnosis or misdiagnosis, resulting in ineffective treatment and increased morbidity and mortality. The diagnosis practice typically includes: 

X-Ray
Multiple serology tests
Multiple courses of ineffective antibiotics
Treatment antifungals after antibiotics aren’t effective

Our test is definitive the same day, which can help patients and healthcare providers avoid the costs and delays associated with a lengthy diagnosis process and multiple doctor visits. The test is FDA-cleared and available at regional reference laboratories. 

About Valley Fever

Valley Fever (Coccidioidomycosis)
Valley Fever (Coccidioidomycosis) is a fungal infection caused by the Coccidioides fungus known to live in the soil in parts of the desert Southwest. It is a recognized endemic in this area, 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
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 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.
GeneSTAT.MDx Coccidioides test
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 High Costs of Valley Fever

  • 150,000 infections per year in Arizona alone, resulting in 1,735 hospitalizations
  • Hospitalizations cost average $50,000 per hospitalization, amounting to $86,000,000 annually

About the GeneSTAT.MDx Coccidioides Test

  • Novel, patented, single-use cartridge 
  • Contains all reagents needed
  • Contains all information required to perform a specific test.
  • Capacity for up to four results with 3 analytical targets plus 1 control 
  • Lyophilized (freeze dried) reagents in each reaction well, providing reagent stability for up to 18 months at ambient storage conditions
  • Cartridge becomes a closed, pressurized system to eliminate issues due to differences in ambient conditions or contamination 
  • RFID tag located on each cartridge contains all information required by the instrument to run the test, and prevents cartridges from accidentally being reused