The molecular diagnostic company said a revised FDA policy on COVID-19 diagnostic testing that was announced Monday will allow the company to "aggressively expand" its presence in the U.S.
FDA Eases Testing Rules
An update to the FDA policy, originally issued Feb. 29, aims to create more rapid testing capacity in the U.S.
The new measures, among other things, call for states to take responsibility for tests used by labs in the respective states.
As opposed to the earlier rule allowing only high-complexity testing consistent with requirements under the Clinical Laboratory Improvement Amendments to carry out testing, the FDA now said it does not object to commercial manufacturers distributing and labs using new commercially developed tests prior to the agency granting emergency use authorization, or EUA, under certain circumstances.
New Rules Widen Co-Diagnostics' Reach
Due to the change in the policy, Co-Diagnostics' test kit will soon be available for use by and marketed to a wide array of U.S. laboratories without first requiring Emergency Use Authorization, the company said.
Co-Diagnostics said it is the first U.S. company to obtain a CE marking –— a seal of approval to be used in Europe — for a COVID-19 test.
"International shipments have continued to escalate," the company said in a press release.
The Logix Smart COVID-19 test kits are being shipped to Italy, Germany, the United Kingdom, Turkey, Greece, the Philippines, Thailand, Australia, Paraguay, Ecuador, Israel, South Africa and Canada, in addition to customers and research institutions in the U.S.
"With no known treatment or approved vaccine for the highly-infectious COVID-19, the need for accurate and rapid diagnoses has never been greater. Our cost-effective Logix Smart CODIV-19 test has been designed to run on a variety of commercially available platforms, with easy-to-interpret results in under two hours. We are confident in our ability to meet the growing demand for this diagnostic," CEO Dwight Egan said in a statement.
The stock was rallying by 27.97% to $11.63 at the time of publication Tuesday.