Biomerica Gets CE Mark for Its H. pylori Diagnostic Test, hp+detect

Irvine, Calif.-based Biomerica has received a CE mark in Europe for its hp+detect diagnostic test for Helicobacter pylori (H. pylori) bacteria.

An infection that poses a strong risk for gastric cancer, H. pylori bacteria is estimated to infect 45 percent of the population in Europe’s five largest countries and 35 percent of the U.S. population.

Biomerica said it will market the test in the EU and in other international markets that accept CE mark certification. The company also recently applied for FDA 510(k) clearance for the H. pylori test.