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 Coccidioides Assay, a confident diagnosis can be made in one day.
Current Testing vs. GeneSTAT Diagnostics
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 to missed diagnosis or misdiagnosis, resulting in ineffective treatment and increased morbidity and mortality. The diagnosis practice typically includes:
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
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