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FDA Approves Roche's COVID-19 Test For US


16 March 2020

OMMCOM NEWS


New Delhi:  Amid all the brouhaha over US President Donald Trump and his fresh measures to contain the new coronavirus spread in the US, the Food and Drug Administration (FDA) has approved a new test from the Swiss pharmaceutical giant Roche that could represent a major breakthrough.

The FDA has issued an Emergency Use Authorization (EUA) for the company's SARS-CoV-2 Test.

It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing.

"Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterised as a pandemic," Thomas Schinecker, CEO of Roche Diagnostics, said in a statement.

"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.

According to npr.org, the initial test approved by the FDA is complex and requires specialized training and equipment.

The Swiss giant Roche has already begun production of the test kits.

"We have about 400,000 tests that are available for the US market," Paul Brown, a senior executive for Roche, was quoted as saying.

Roche expects to manufacture about 1.5 million tests per month.

"This action today shows our agency's dedication to working around the clock to review and authorize diagnostics during this public health emergency," said FDA Commissioner Stephen Hahn in a statement last week.

"We have been engaging with test developers and encouraging them to come to the FDA and work with us".

It is the third EUA granted by the US regulator during the current outbreak of the COVID-19 virus. The COVID-19 pandemic has killed more than 60 Americans and more than 5,800 people worldwide.

Over 156,000 people have been infected globally.

Thermo Fisher, the largest maker of scientific tools, also said it aims to produce up to 5 million of a new test to detect the novel coronavirus that causes Covid-19.

(IANS)