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Roche plans to launch rapid COVID-19 antigen test later this month

Swiss pharma also intends to file for emergency approval in the US

Swiss pharma company Roche has plans to launch its rapid SARS-CoV-2 antigen test in late September for markets accepting the CE mark in the EU.

At the same time, Roche also announced its intention to file the test for emergency use authorisation with the US Food and Drug Administration, with the hope of gaining approval on both sides of the Atlantic.

The rapid test can identify the presence of SARS-CoV-2 infection, which causes COVID-19, in people suspected to carry the virus in as little as 15 minutes.

It can also be used as an initial screening test for individuals that have been exposed to SARS-CoV-2 infected patients or high-risk environments.

According to Roche, the test has a sensitivity of 96.2% and 99.68%, based on samples from two independent study centres. Roche plans to make 40 million test available per month at launch, and intends to double this capacity by the end of the year.

The test is intended to be performed by health care professionals in a number of different settings, which offers a crucial alternative option when laboratory testing is inaccessible.

“As the COVID-19 pandemic persists, healthcare systems remain challenged. Testing continues to be an important focus for many countries. Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the right course of treatment,” said Thomas Schinecker, chief executive officer of Roche Diagnostics.

“COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus,” he added.

Last week, Novacyt announced the launch of its new diagnositic test which can tell the difference between COVID-19 and the winter flu.

The Winterplex test includes two gene targets specific to COVID-19, as well as gene targets for influenza A and B and respiratory syncytial virus (RSV).

Roche’s rapid antigen test is the tenth addition to its diagnostic portfolio for COVID-19, either through testing in the laboratory or at the point of care.

This portfolio currently includes molecular, serology and digital solutions that can help to diagnose COVID-19 during the initial stages of COVID-19 infection, during the recovering phase, and also following the resolution of infection.

Article by
Lucy Parsons

2nd September 2020

From: Regulatory



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