Co-Diagnostics Inc (NASDAQ: CODX) shares have been on a roll following the outbreak the COVID-19, the latest coronavirus strain that has stirred fears and anxiety. Shares received another boost Thursday following disclosure from the company that its COVID-19 test kit demand remains robust.
The molecular diagnostics company that uses a patented platform for the development of diagnostic tests said demand, both domestic and international, surged for its COVID-19 detection kits in recent weeks, leading to increased product shipments. The increase comes after the FDA changed its policy Feb. 20 and the number of cases testing positive for the disease burgeoned worldwide.
Co-Diagnostics' CE-IVD Logix Smart COVID-19 Test Kit has been sought for internationally as well as by U.S. clinical labs, which have requested the company's reagents to be used according to the FDA's new policy of allowing the labs to begin testing COVID-19 patients after in-house validation even as the test awaits FDA Emergency Use Authorization.
"We are already manufacturing and shipping coronavirus products to countries on 4 continents along with additional demand we are experiencing pursuant to the policy change," said CEO Dwight Egan.
Co-Diagnostics said it's looking ahead to get emergency use clearance for use as an in vitro diagnostic by the FDA, as well as by the CDSCO in India. The company expects to more than triple its manufacturing capacity for this test in India to meet potential demand in the eastern hemisphere.
"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," the company said.
The stock was surging 24% to $14.83 in pre-market trading following the 16.43% retreat in the previous session. The stock is up about 1,250% in the year-to-date period.