Diasorin Gains FDA 510(k) Clearance for Multiplex Respiratory Test

Original from: 360dx

Diasorin said Friday that it has secured US Food and Drug Administration 510(k) marketing clearance for a syndromic respiratory disease test.

The Saluggia, Italy-based company's Simplexa COVID-19/Flu A/B & RSV Direct Kit is used for the simultaneous detection and differentiation of SARS-CoV-2, influenza A and B viruses, and respiratory syncytial virus nucleic acids in nasopharyngeal or nasal swab samples from patients with signs and symptoms of respiratory disease. The test provides results within 45 minutes and is designed for use with the company's PCR-based Liaison MDX instrument in combination with its eight-well Direct Amplification Disc, which is used for sample-to-answer testing.

"Our dedication to offering adaptable testing solutions is reflected in the addition of this 4-plex kit to our comprehensive range of COVID-19 and flu testing assays, ensuring that laboratories are equipped to handle dynamic respiratory seasons and evolving healthcare environments," Angelo Rago, president of Diasorin's Luminex business, said in a statement.

Diasorin also submitted in July its Liaison NES point-of-care molecular testing system and a four-target respiratory panel for FDA 510(k) marketing clearance.

Source: Diasorin Gains FDA 510(k) Clearance for Multiplex Respiratory Test