Chembio Investors Sue After FDA Questions Covid Antibody Test

Chembio Diagnostics Inc. allegedly misled investors by claiming its coronavirus antibody test was “100% accurate” when it wasn’t, according to a would-be class complaint filed in New York federal district court.

The diagnostic solutions firm told investors that its test “provides high sensitivity and specificity” in the months before the Food and Drug Administration identified concerns about the test’s accuracy, the complaint filed Thursday in the U.S. District Court for the Eastern District of New York said.

Chembio’s test was “one of the first antibody tests authorized by the FDA” during the Covid-19 pandemic, the complaint said. But the regulator ...