CLN - Regulatory Roundup

FDA Clears First Molecular Test for Valley Fever

Regulatory Roundup: March 2018

DxNA has received Food and Drug Administration (FDA) clearance for the DxNA GeneSTAT.MDx Coccidioides test, making this the first FDA-authorized molecular test for the rapid detection of coccidioidomycosis, a fungal infection also known as valley fever. The test runs on DxNA’s GeneSTAT system and identifies both of the Coccidioides strains that cause valley fever. In a comparison with the gold standard testing method for this disease, a multi-center clinical study found that the DxNA assay performs with 100% sensitivity and 99.6% specificity. The gold standard method involves culturing Coccidioides in a Biosafety Level 3 laboratory, which takes up to 21 days and potentially exposes laboratory personnel to the highly infectious fungus. The GeneSTAT.MDx Coccidioides aims to improve on this by directly testing a patient specimen and providing a same-day result. DxNA hopes that this will also enable testing for valley fever at on-site labs and reduce the need to send patient samples to reference labs.

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