Roche: to launch rapid antigen test for coronavirus
(CercleFinance.com) - Roche said on Wednesday that in late September it will launch a coronavirus test that provides results in just 15 minutes, for markets accepting the CE mark.
The Swiss drugmaker's antigen test - performed by healthcare professionals using a nasopharyngeal swab - is intended to help in the early diagnosis of patients showing clinical symptoms, it said.
According to Roche, the test has a sensitivity of 96.5% and a specificity of 99.7%, based on 426 samples from two independent study centers.
Roche said it also intends to file for Emergency Use Authorisation (EUA) to the US Food and Drug Administration (FDA).
At launch, there will be 40 million rapid tests available per month, it added.
Copyright (c) 2020 CercleFinance.com. All rights reserved.
The Swiss drugmaker's antigen test - performed by healthcare professionals using a nasopharyngeal swab - is intended to help in the early diagnosis of patients showing clinical symptoms, it said.
According to Roche, the test has a sensitivity of 96.5% and a specificity of 99.7%, based on 426 samples from two independent study centers.
Roche said it also intends to file for Emergency Use Authorisation (EUA) to the US Food and Drug Administration (FDA).
At launch, there will be 40 million rapid tests available per month, it added.
Copyright (c) 2020 CercleFinance.com. All rights reserved.