Domestic product shipments increased for Co-Diagnostics after the Food and Drug Administration widened access to testing for the virus Feb. 29, the company said. The growing number of people infected by the virus also sparked sales around the world.
“International interest has grown for Co-Diagnostics’ CE-IVD Logix Smart COVID-19 test kit,” the company said in a statement.
“And numerous requests have been received from U.S. clinical laboratories for the company’s reagents to be used according to the FDA’s new policy allowing those labs to begin testing patients for COVID-19 after in-house validation, while awaiting FDA Emergency Use Authorization,” the company added.
Co-Diagnostics said it was shipping its coronavirus kits to four continents.
“The company continues to advance toward emergency use clearance for use as an in vitro diagnostic by the FDA as well as by the CDSCO [India’s FDA],” Co-Diagnostics CEO Dwight Egan said in the statement.
“Our facility in that country stands to more than triple our manufacturing capacity for this test, especially important to meet potential demand in the eastern hemisphere,” Egan said.
The news obviously is good for Co-Diagnostics’’ finances. “The additional revenues we are experiencing along with our solid balance sheet and debt-free status have all facilitated our efforts to support the global response to coronavirus,” Egan said.
Almost 97,000 people have been diagnosed with the coronavirus, and more than 3,300 have died. California has declared a state of emergency, as cases there have soared above 60.
Co-Diagnostics shares traded at $14.50, up 20.87%.