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June 21, 2021

FDA grants EUA to Roche’s 20-minute Covid-19 PCR test

The test can be used for symptomatic or asymptomatic people and delivers results in 20 minutes.

Roche has received Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for the use of its cobas SARS-CoV-2 Nucleic acid test in point of care settings.

Indicated for screening symptomatic as well as asymptomatic people, the singleplex real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test can detect Covid-19 infections in 20 minutes.

The test could aid in the making of rapid, informed decisions at doctors’ offices, screening sites and emergency or primary care, as well as other point of care settings.

Authorised for use on the cobas Liat System, the test will be made available in markets accepting the FDA EUA and CE mark in July.

Roche Diagnostics Solutions point of care head Ian Parfrement said: “We learn more about Covid-19 every day and Roche continues to develop solutions that will help healthcare systems around the world slow and eventually defeat this pandemic.

“Preventing further spread of the virus is crucial for public health and the continued safe reopening of our communities worldwide.”

The latest test will provide wide-ranging SARS-CoV-2 strain coverage under Roche’s variant surveillance programme, further aiding healthcare decisions.

Not all people infected with SARS-CoV-2 show symptoms, but they can still spread the infection. Roche noted that a test that can screen asymptomatic individuals is vital to fighting the Covid-19 pandemic.

The cobas Liat System, which leverages PCR technology, is designed to automate the testing process, streamline workflows and facilitate healthcare providers to carry out molecular testing in various point-of-care settings.

The latest development comes after Roche obtained CE mark for its SARS-CoV-2 Antigen Self Test Nasal, which can be used for rapid testing of Covid-19 in an at-home setting using a nasal swab.

Apart from providing existing tests for SARS-CoV-2, influenza A/B, respiratory syncytial virus, Group A streptococcus and Clostridioides difficile, Roche is also developing assays for other infectious diseases.

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