The US Food and Drug Administration (FDA) is now allowing the use of new diagnostic technologies that will test for the Coronavirus, or COVID-19, at multiple hospitals and healthcare facilities in the country. This comes as cases of Coronavirus deaths are being confirmed in the US and there are now confirmed cases every day. The regulator says this test can now be used even before they have had a chance to review the Emergency Use Authorization request. However, the condition for this is that only labs that can handle high-complexity tests will be able to use this new diagnostic method and the FDA insists they are pushing this through to ensure there is wider availability of Coronavirus test options.
“We believe this policy strikes the right balance during this public health emergency. We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S. We are not changing our standards for issuing Emergency Use Authorizations. This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation,” says,” said FDA Commissioner Stephen M. Hahn, M.D. in an official statement.
According to the latest numbers, there are 89,074 confirmed Coronavirus cases around the world. The global death toll has crossed 3,000 and the Coronavirus cases have been reported in 60 countries. The worst hit is China, with 80,026 cases reported in Mainland China as well as 98 in Hong Kong and 10 in Macau. After China, the worst hit is South Korea with 4,212 confirmed cases followed by Italy clocking 1,694 confirmed Coronavirus cases and 978 reported cases in Iran.
The US Centers For Disease Control And Prevention (CDC) have been criticized for being underprepared to deal with the potential Coronavirus spread in the US. At the time of writing this, CDC data suggests they have done only 472 tests thus far using the kits available. Science Magazine reports that South Korea has tested more than 65,000 people thus far. The same publication also reports that the World Health Organization (WHO) has shipped testing kits to 57 countries. China had five commercial tests on the market 1 month ago and can now do up to 1.6 million tests a week. “The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” says Nancy Messonnier, M.D., director of the CDC’s Center for the National Center for Immunization and Respiratory Diseases (NCIRD).
The WHO in one of its daily briefings recently suggested that there are multiple Coronavirus test kits that are commercially available and cost as little as around $5 per kit.