Quidel files for emergency use of direct test of coronavirus

Quidel (OTC:QDEL) has submitted an application to the FDA seeking emergency use authorization for its Lyra Direct SARS-CoV-2 Assay that allows direct sampling processing (no RNA extraction step).

The company says the test uses a simple 10-minute heat step instead of a traditional extraction step thereby saving ~50 minutes in processing time.

It is making ~500K tests per week and has begun shipping product to customers. The test can be performed on the same six instruments as the Lyra SARS-CoV-2 Assay.

https://seekingalpha.com/news/3563607-quidel-files-for-emergency-use-of-direct-test-of-coronavirus