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FDA okays Roche’s COVID-19 diagnostic test

Increases capacity for testing as coronavirus cases grow


The US Food and Drug Administration (FDA) has approved Roche’s diagnostic test for the novel coronavirus, authorising it for emergency use.

The cobas SARS-CoV-2 test is intended for qualitative detection of the novel coronavirus (SARS-CoV-2), which causes the respiratory disease COVID-19.

Nasopharyngeal and oropharyngeal swab samples are taken from patients who have symptoms consistent with COVID-19, with these sample then sent to hospitals and laboratories for testing on Roche’s cobas 6800/8800 systems.

These systems can produce test results in three and half hours, with a total of 1,440 results provided by the cobas 6800 system and 4,128 results by the cobas 8800 system within a 24-hour period.

According to the Swiss pharma, millions of tests a month will be available for use on both systems, which it said offers improved operating efficiency and flexibility.

Roche said a CE-IVD test is also available in markets accepting the CE mark, for patients with symptoms of COVID-19 in affected areas.

CE marking indicates that an in vitro diagnostic (IVD) can be legally commercialised in the European Union.

"Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterised as a pandemic.  It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2,” said Thomas Schinecker, CEO, Roche Diagnostics.

“Over the last weeks, our emergency response teams have been working hard to bring this test to the patients. CE-mark certification and the FDA’s granting of EUA supports our commitment to give more patients access to reliable diagnostics which are crucial to combat this serious disease,” he added.

Roche’s cobas systems are widely available across the globe, meaning the authorisation of the test could increase the current rate at which suspected cases are being diagnosed.

A number of countries – including the US – have been criticised for not testing their populations widely or quickly enough, as fears that the coronavirus will spread at an alarming rate grow across the world.

According to the World Health Organization’s (WHO) latest situation report – issued yesterday – there have been 125,048 confirmed cases of the coronavirus, with 4,613 deaths of infected individuals.

The WHO labelled the outbreak a pandemic earlier this week, after cases continue to grow in a number of countries at the same time – WHO director-general Tedros Adhanom Ghebreyesus maintained, however, that the virus could still be controlled with the right measures.

Article by
Lucy Parsons

13th March 2020

From: Regulatory



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