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DiaSorin Gains FDA 510(k) Clearance for COVID-19 PCR Test

NEW YORK — DiaSorin said Wednesday it had gained US Food and Drug Administration 510(k) clearance for a swab-based COVID-19 PCR assay that delivers results in about one hour.

The Saluggia, Italy-based firm said its Simplexa COVID-19 Direct Kit uses nasopharyngeal or nasal swab specimens, and the automated molecular assay is designed for use by hospitals and commercial laboratories on DiaSorin's real-time PCR-based Liaison MDx instrument. DiaSorin said the assay does not require sample pretreatment, which hastens results and allows prompt decisions on patient isolation and treatment.

The FDA had granted Emergency Use Authorization for the assay in March 2020.

The assay targets two regions of the SARS-CoV-2 genome to maintain sensitive and specific performance against variants of concern, DiaSorin said. The company has also submitted for FDA review the Simplexa COVID-19 and Flu A/B Direct assay for differential diagnosis during flu season.

The US Department of Health and Human Services funded development of the kit through its Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority, DiaSorin said.

The FDA recently has been encouraging firms to file for full clearance or approval of their COVID-19 tests, rather than seek EUA, as the pandemic continues.

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