The FDA granted emergency use authorization to Chembio Diagnostics’ (NASDAQ:CEMI) dual path platform (DPP) COVID-19 system.
The system is a serological point-of-care test and analyzer that provides numerical readings for both immunoglobulin G and M levels within 15 minutes from a finger stick drop of blood.
“The flexibility of having two analyzers and a system that provides high sensitivity and specificity that is generally consistent with the performance of Chembio’s other DPP platform tests as part of our offering places us in a unique position to serve a variety of markets,” Rick Emberly, Chembio’s CEO, said in a statement.
“Additionally, we are pleased to announce that our manufacturing team has produced and shipped our first lots of the COVID-19 systems, and we look forward to providing further product within the U.S. and abroad,” he added.
