The Mexican Department of Epidemiology has approved for sale a COVID-19 diagnostic test manufactured by Co-Diagnostics (NASDAQ:CODX). In addition, CoSara, a joint venture that the molecular diagnostics company formed in India, has also been cleared to sell test kits in the world's second-most populous country.
Demand for Co-Diagnostics products has soared since the FDA granted it an emergency use authorization (EUA) to sell the Logix Smart COVID-19 test on April 3. The Centers for Medicare and Medicaid Services (CMS), which regulates all U.S. laboratory testing performed on humans, has also approved the sale of the test to roughly 260,000 clinical laboratories across the country.
On Monday, Co-Diagnostics said orders for the Logix Smart COVID-19 test are still strong across the U.S., and that demand is spreading. Unfortunately, the company did not provide any recent sales figures to quantify just how strong that domestic demand has been.
In addition, Co-Diagnostics' could soon begin to record ballooning sales of test kits abroad. Earlier this month, the company released some amazing performance data that should boost demand in Mexico, India, and dozens of other countries. Results from a validation test suggest its COVID-19 test is 100% accurate: In the study, it didn't miss any positives, and it didn't report any false positives either.
In India, CoSara will manufacture test kits the joint venture will sell there. Co-Diagnostics' partner expects to begin filling orders immediately following the successful evaluation of those test kits by Indian regulators.