Shares of Co-Diagnostics (NASDAQ:CODX) were jumping 11.8% higher as of 11:07 a.m. EST on Monday after the company announced that its coronavirus test kits are now available to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) guidelines.
Normally labs wouldn't be able to buy Co-Diagnostics' coronavirus test kits until the U.S. Food and Drug Administration (FDA) approved the tests. However, Emergency Use Authorizations (EUA) allow labs to use products that could be effective in diagnosing, treating, or preventing diseases for which the potential for a public health emergency exists.
The FDA issued a new policy on Feb. 29, 2020, allowing certain CLIA-certified labs to begin using validated diagnostics for COVID-19, the disease caused by the novel coronavirus, even before the agency has completed a review of the labs' EUA requests. This move underscores the FDA's desire to move quickly in response to the coronavirus outbreak.
Co-Diagnostics CEO Dwight Egan stated, "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." He added, "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."
Co-Diagnostics is talking with multiple CLIA labs about using its COVID-19 tests. The company has already shipped its tests to several countries. The healthcare stock has been one of the biggest winners so far in the coronavirus epidemic.