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Mawi DNA Gets 510(k) for SARS-CoV-2 Sample Collection Kit

NEW YORK – Mawi DNA Technologies said Tuesday that it has secured US Food and Drug Administration 510(k) clearance for a kit that secures saliva and upper respiratory tract samples and removes the need for RNA extraction during molecular testing.

The California-based firm's iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) is designed for the collection, transportation, and storage of upper respiratory tract and saliva samples at ambient temperature for up to several weeks. The device is used to inactivate samples suspected of containing SARS-CoV-2 virus for use with molecular diagnostic tests, and the firm said the kit has been used elsewhere in the world for population-scale sampling in response to COVID-19.

Mawi DNA CEO Bassam El-Fahmawi said in a statement that the firm created the device with a goal of hastening the response to pandemics by removing that need for RNA extraction or for consumables to process viral samples. adding the results also increased testing throughput. The iSWAB-RC-EL also inactivates viruses using a nontoxic formulation free of guanidine salts.