Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced today that following a recent change to the Food and Drug Administration’s (FDA) policy towards the coronavirus outbreak, the Company’s coronavirus test kits are available to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) for use according to the FDA guidelines.
The Company is in discussions with certain qualified CLIA laboratories who can use COVID-19 tests built on Co-Diagnostics’ platform technology in their Emergency Use Authorization (EUA) submissions with the FDA. 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 the FDA.
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. Co-Diagnostics’ patented CoPrimer™ technology has been vetted in numerous applications by some of the most highly-respected firms focusing on molecular technology, and we are pleased to make this platform available domestically immediately to support the FDA’s mission to slow the spread of this disease and mitigate its impact.
“In addition to these efforts with US CLIA labs following the change in US policy, our CE-IVD Logix Smart™ COVID-19 test kit has already been shipped to countries on several continents, both for performance evaluation as well as for use as a diagnostic tool where its CE marking makes that possible.”
The policy change is a result of the FDA’s commitment to aggressively address the current coronavirus outbreak, and allows CLIA laboratories to use tests that have been developed and validated for detection or diagnosis of the novel coronavirus before the FDA has completed the review of the laboratories’ submission under Emergency Use Authorization (EUA) guidance. Prior to the chance in policy, all laboratories wishing to test for COVID-19 were required to complete their EUA submission and receive clearance from the FDA.