Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced Thursday that both domestic and international demand has surged for its novel coronavirus detection kits in recent weeks leading to increased product shipments, following the Food and Drug Administration’s (FDA) change in policy on February 29, and an ever-larger number of patients testing positive for the disease worldwide.
Shares of the Company jumped more than 25% Thursday morning.
International interest has grown for Co-Diagnostics’ CE-IVD Logix Smart™ COVID-19 Test Kit, and numerous requests have been received from US 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.
Co-Diagnostics CEO Dwight Egan commented, "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. Recent customer purchases have also included diagnostic equipment to facilitate the availability of molecular diagnostics world-wide, specifically in connection to this global health crisis.
"The Company continues to advance towards emergency use clearance for use as an in vitro diagnostic by the FDA as well as by the CDSCO in India. 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. 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."