serology test

FDA tightens requirements for COVID-19 serology tests; Novartis, Propeller Health's digital inhaler moves toward EU approval and more digital health news briefs

By Dave Muoio 03:43 pm May 4, 2020

Following numerous reports of underperforming COVID-19 antibody tests, the FDA has raised the bar for these products in a revision to its emergency testing policy. As of today, commercial manufacturers that notify the agency of their intent to submit a test for Emergency Use Authorization are required to do so within 10 business days from the date of notification. Further, the FDA has recommended...

Cellex becomes first company to land FDA Emergency Use Authorization for COVID-19 serology testing

By Laura Lovett 02:25 pm April 3, 2020

Earlier this week Cellex became the first company to gain an FDA Emergency Use Authorization for a serology test. The test was designed to identify specific antibodies in the blood linked to coronavirus, which means it can be used to identify past coronavirus infections. Before this test, the products on the market were designed to detect or diagnose if someone currently has the virus. ...