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FDA Clears DxNA's Valley Fever Molecular Test

NEW YORK (GenomeWeb) – The US Food and Drug Administration has cleared DxnA's GeneSTAT.MDx Coccidioides test for valley fever, the company announced on Wednesday.

The test was cleared to run on the PCR-based GeneSTAT system and is intended for the rapid detection of Coccidioidomycosis. It can provide a definitive diagnosis for both Coccidioides strains that cause the infection and was developed based on intellectual property exclusively licensed from the Translational Genomics Research Institute and the Northern Arizona University.

DxNA said that current valley fever testing is done by growing the fungus in a biosafety level 3 laboratory, a method that can take as many as 21 days to get results, and expose laboratory personnel to the highly infective fungus. In contrast, the GeneSTAT.MDx test can be performed directly on patient specimens, provides same-day results, and has demonstrated 100 percent sensitivity, 99.6 percent specificity, and 100 percent reproducibility.

With the FDA clearance, clinical labs and healthcare facilities will have access to the molecular test, DxNA said.

The St. George, Utah-based firm said in July that it filed for FDA clearance for the test.