Rapid coronavirus test with 45-min detection time gets fast-tracked, greenlit by US FDA; will be rolled out starting 30 March
Cepheid's rapid Covid-19 test is designed to work on any of the company's 23,000+ automated GeneXpert Systems worldwide.
The American Food and Drug Administration has approved the first rapid diagnostic test for the novel coronavirus , which could encourage quicker and more testing for the infection, amidst the ongoing global COVID-19 pandemic. With a detection time of about 45 minutes, the test couldn't have come at a better time – as the United States, China, India and many nations barring the EU, struggle to meet the rapidly growing demand for coronavirus testing.
The test was developed by California-based molecular diagnostics company Cepheid. In a media briefing on 21 March, the company said it received an "emergency-use authorization" from the FDA for its rapid COVID-19 test, which will primarily be released to hospitals and emergency rooms starting as soon as possible. The US FDA confirmed the rapid test's approval in a statement, clarifying that the company intends to roll out its testing kits to medical facilities by 30 March.
The emergency clearance comes only a week after a similar clearance was given to Roche, which was given fast-track approval for a test that could diagnose the novel coronavirus in three hours. However, the current testing regime anywhere in the world requires samples to be sent to a centralized lab, and the results could take days.
The United States is not even close to meeting the demand for coronavirus testing, while medical experts have predicted that testing delays and chaos will likely cost lives, including those of doctors and nurses.
Cepheid's diagnostic test for COVID-19 is designed to work on any of the company's 23,000+ automated GeneXpert Systems globally, the company said.
Over 1,200 such Cepheid GeneXpert Systems were installed across various Indian medical institutions in 2017 and 2018 as part of the National Tuberculosis Control Programme in India, after approval by the World Health Organisation (WHO) in 2010. The Systems don't require any special training to carry out the testing, and can run around the clock if needed, Cepheid's President Warren Kocmond said in a statement.
"An accurate test delivered close to the patient can be transformative – and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources," David Persing, chief medical and technology officer at Cepheid, said in the statement.
Cepheid didn't disclose any information on how much the test will cost on the market.
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