Co-Diagnostics is a molecular diagnostics company with a patented platform for the development of diagnostic tests.
The CLIA regulate laboratory testing and require clinical laboratories to be certified by their state as well as the Center for Medicare and Medicaid Services before they can accept human samples for diagnostic testing.
Following a recent change to the Food and Drug Administration’s policy toward the coronavirus outbreak, the company’s coronavirus test kits are now available to laboratories certified under the CLIA for use according to the FDA guidelines, Co-Diagnostics said in a press release.
Co-Diagnostics said it is in discussions with qualified CLIA laboratories that can use COVID-19 tests built on Co-Diagnostics' platform technology in their emergency use authorization submissions with the FDA.
“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,” CEO Dwight Egan said in a statement.
Co-Diagnostics shares were trading up 16.33% at $15.39 at the time of publication Monday.
The stock has a 52-week high of $21.75and a 52-week low of 69 cents.