Biomerica, a global provider of advanced medical diagnostic products, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Hp Detect Stool Antigen ELISA test, a new product designed to detect the presence of the H. pylori bacteria.
The Biomerica Hp Detect test detects the presence of the H. pylori bacteria which infects approximately 35% of the U.S. population. Over 80% of gastric cancers are attributed to H. pylori infection, and gastric cancer is the third most common cause of cancer-related death worldwide. Physicians and medical centers will be able use the results from the Hp Detect Stool Antigen test to diagnose the presence of H. pylori and assess H. pylori infection status after treatment.
“Testing for H. pylori eradication to assess status after treatment is crucial, especially in the context of increasing antibiotic resistance,” says William Chey, MD, an expert in the management of H. pylori infection and Chief, Division of GI and Hepatology, Michigan Medicine.
Further reading: H. Pylori Infection: Improving Diagnostic Accuracy and Clinical Outcomes
“This FDA clearance is a milestone in our commitment to bringing a diagnostic solution for over 115 million people suffering from H. pylori infection across the U.S.,” says Biomerica’s CEO Zack Irani. “We are particularly excited about this product as it has been shown to be highly accurate and has several key advantages for laboratories, physicians and patients. We have also created an efficient, low-cost manufacturing process that should enable high gross margins on this product.”
