Business
Biomerica Announces CE Mark for Its H. pylori Diagnostic Test, hp+detect™
- Attaining CE Mark is a major step toward commercialization – - World Health Organization (WHO) lists H. pylori among the 16 antibiotic-resistant bacteria
About this update from Biomerica, Inc.
[{"type":"text","content":"- Attaining CE Mark is a major step toward commercialization – - World Health Organization (WHO) lists H. pylori among the 16 antibiotic-resistant bacteria that pose the greatest threat to human health and designated H. pylori as a Class 1 carcinogen, meaning that it is a known cause of cancer - - 45% of the population in Europe’s five largest countries are afflicted with H. pylori - IRVINE, Calif., May 12, 2022 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical diagnostic and therapeutic products, announces CE Mark for its hp+detect™ diagnostic test that detects Helicobacter pylori (H. pylori) bacteria. The Company will begin to market and sell its hp+detect™ diagnostic test in the European Union (EU) and other international countries following registration of the product in each country in which it is sold. About hp+detect™The Biomerica hp+detect™ product detects H. pylori bacteria which is estimated to infect 35% of the U.S. population and 45% of the population in Europe’s five largest countries. H. pylori infection is the strongest known risk factor for gastric cancer and gastric cancer is the third most common cause of cancer-related death worldwide. Physicians and medical centers will be able use hp+detect™ to diagnose H. pylori infection and monitor the safety and efficacy of treatment. Biomerica’s Chairman and Chief Executive Officer Zack Irani stated, “As we await clearance from the FDA for hp+detect™ to be sold in the U.S., following our recent 510(k) submission, we are working to begin selling this product in the EU and other international countries. Attaining this CE Mark is a key step in the company’s commitment to bringing our diagnostic solution to the broader EU market.” About Biomerica (NASDAQ: BMRA)Biomerica, Inc. (www.biomerica.com) is a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in home and in physicians' offices) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. The Company's products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica’s primary focus is on gastrointestinal and inflammatory diseases where the Company has multiple ...