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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.
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.