QCOSTARICA – Roche announced Tuesday that it intends to launch a high-volume Antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.
The Swiss pharmaceutical giant said the new antigen test will be carried out in machines called Cobas, available in many hospitals and laboratories, which can treat up to 300 samples per hour and give a result in 18 minutes.
The test is planned to be made available at the end of 2020 for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA).
This test, called Elecsys® SARS-CoV-2 Antigen and which will be carried out in laboratories, allows detecting the presence of specific antigens of the disease, the company said in a statement.
The test can be used either as an alternative to PCR testing when it is not available or the devices to do it are overwhelmed, Roche added.
Since the beginning of the health crisis, Roche’s portfolio has already launched eight tests for coronavirus infections, one of which differentiates COVID-19 from influenza.
See the full media release here.