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FDA green lights rapid coronavirus diagnostic test

From Regulatory

The US Food and Drug Administration (FDA) has approved a rapid test that could diagnose whether an individual has the novel coronavirus disease COVID-19 within 45 minutes.

The test – developed by California, US-based Cepheid – could take only 45 minutes to determine if someone has COVID-19, offering a quick diagnostic tool at a time when hospitals are being overwhelmed with possible cases.

Cepheid revealed in a statement issued on Saturday that the tests will begin shipping this week, with plans to make the point-of-care diagnostics available by 30 March.

“Our dedicated team at the FDA has been working nonstop to expedite the review and authorization of novel diagnostics during the COVID-19 public health emergency,” said Stephen Hahn, commissioner of the FDA.

“Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centres and emergency rooms, instead of samples being sent to a laboratory,” he added.

The approval of Cepheid’s test comes as criticism grows over how the US is handling its coronavirus testing strategy.

That includes criticism levied at the Centres for Disease Control and Prevention’s (CDC) allegedly confusing and restrictive testing criteria.

The CDC has identified those who are at the highest priority for testing, including: hospitalised patients who show symptoms; those with high-risk conditions who are symptomatic; and healthcare professionals who within 14 days of symptom onset had close contact with a laboratory-confirmed COVID-19 case.

However, many in the US have been unable to access testing, despite concerns of being exposed to the virus, because they did not meet the criteria laid out by the CDC.

The World Health Organization (WHO) has been urging countries around the world to adopt a comprehensive testing strategy, with its director-general Tedros Adhanom Ghebreyesus calling for countries to “test every suspected case”.

“The most effective way to prevent infections and save lives is breaking the chains of transmission. And to do that, you must test and isolate,” he added.

The FDA has already approved another COVID-19 test from Roche, although this diagnostic only facilitates laboratory testing, with samples requiring testing using the pharma company's cobas 6800/8800 systems.

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