NEW YORK — Biomerica said on Thursday that it has received CE marking for its Hp+detect Helicobacter pylori test.
Hp+detect is designed to detect the presence of H. pylori, a key cause of gastric cancer and peptic ulcers, according to the Irvine, California-based company. Earlier this year, Biomerica submitted the test to the US Food and Drug Administration for 510(k) clearance.
"As we await clearance from the FDA for Hp+detect … we are working to begin selling this product in the EU and other international countries," Biomerica Chairman and CEO Zack Irani said in a statement. "Attaining this CE mark is a key step in the company's commitment to bringing our diagnostic solution to the broader EU market."