FDA is upping its response to address the novel coronavirus outbreak. The policy is aimed at laboratories seeking to develop diagnostic tests for the coronavirus.
The policy allows laboratories to develop and begin to use the diagnostics before FDA has completed a review of their Emergency Use Authorization (EUA) requests.
"We believe this policy strikes the right balance during this public health emergency," said FDA Commissioner Stephen M. Hahn, M.D. "We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from 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."
Co-Diagnostics is an in vitro diagnostics firm that has been out in the forefront during the outbreak. Last month the Salt Lake City, UT-based company received CE mark Logix Smart Coronavirus COVID-19 Test.
In response to FDA’s new policy, the company said it is in discussions with certain qualified CLIA laboratories who can use COVID-19 tests built on Co-Diagnostics' platform technology in their EUA submissions with FDA. Co-Diagnostics said once the labs have completed the process required for the EUA submission, it is expected that they would purchase the company’s reagents for use in their COVID-19 diagnostics, as permitted by FDA.
In a release Dwight Egan, CEO of Co-Diagnostics, commented, “We believe this change will allow the diagnostics industry to respond to the developing situation much more rapidly and effectively, and we applaud the FDA for taking such aggressive action to address the coronavirus outbreak.”
In late January, FDA laid out its strategy to handle any potential coronavirus outbreaks. Early last month, FDA granted EUA for the Centers for Disease Control and Prevention’s Coronavirus detection test. Up until then, the Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel has only been used at CDC laboratories.
FDA’s new policy comes at a time when there are 89,856 cases worldwide. About 3,069 have succumbed to the virus and 45,636 have recovered, according to Worldometer. In the U.S, there have been two reported deaths.