FDA Issues EUA to Rutgers Lab for First COVID-19 Home Collection Diagnostic Test

By MedTech Intelligence Staff

The prescription-only diagnostic allows patients to self-collect saliva samples to test for SARS-CoV-2.

Attend the MedTech Intelligence “Emergency Use Authorization” Webinar | May 21, 2020Today FDA announced an emergency use authorization (EUA) for the first COVID-19 laboratory developed test that allows patients to collect their own saliva samples at home. Using the molecular test, which was developed by Rutgers Clinical Genomics Laboratory, patients can collect a saliva sample using a special self-collection kit, which they return to the Rutgers lab in a sealed package.

This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” said FDA Commissioner Stephen M. Hahn, M.D. in an agency news release, stating that FDA has authorized more than 80 COVID-19 tests thus far. “Adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency.”

The EUA is limited to testing performed at the Rutgers lab using its molecular LDT COVID-19 authorized test for saliva specimens collected using the SDNA-1000 Saliva Collection Device by Spectrum Solutions, LLC.

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