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DxNA Files for FDA Clearance of MDx System, Valley Fever Assay

NEW YORK (GenomeWeb) – Molecular diagnostics firm DxNA on Monday announced it has filed a submission to the US Food and Drug Administration for 510(k) clearance of its real-time PCR system and a test for Valley Fever.

The firm's GeneSTAT system was developed based on intellectual property licensed exclusively from the Translational Genomics Research Institute. The CE-marked platform does not require a specially trained molecular lab technologist to run and uses a closed-cartridge design, eliminating PCR product contamination issues, and the effects of ambient conditions, according to DxNA's website.

The GeneSTAT Coccidiodes molecular test is for the rapid detection of Coccidiomycosis. It can be run directly on patient specimens for same-day results. According to DxNA, it would allow clinical laboratories and healthcare facilities in regions where Valley Fever is endemic to test for the ailment without having to send specimens to reference laboratories.

"This is an important milestone for DxNA and our partners to bring to market a test that provides patients and their healthcare providers the potential for a much earlier and more definitive Valley Fever diagnosis," DxNA CEO David Taus said in a statement. "This is also a critical milestone for DxNA to transition as a company from development to commercial stage."