Biomerica, a leading provider of medical diagnostic products, has recently received FDA 510(k) clearance for its Hp Detect Stool Antigen ELISA test. This new test is designed to detect the presence of Helicobacter pylori (H. pylori) bacteria, which infects about 35% of the U.S. population.
Key Points from the Article:
- Significance of H. pylori Detection: H. pylori infection is a major health concern, as it is linked to over 80% of gastric cancers, making it the third most common cause of cancer-related death worldwide. The ability to accurately detect this bacteria is crucial for early diagnosis and treatment.
- Use of the Hp Detect Test: The Hp Detect Stool Antigen test will enable physicians and medical centers to diagnose the presence of H. pylori. It is also useful in assessing the infection status of H. pylori after treatment. This is particularly important in the context of increasing antibiotic resistance.
- Expert Opinion: William Chey, MD, an expert in managing H. pylori infection and Chief of the Division of GI and Hepatology at Michigan Medicine, emphasized the importance of testing for H. pylori eradication to assess treatment status.
- Advantages of the Test: According to Biomerica’s CEO Zack Irani, the Hp Detect test is highly accurate and offers several key benefits for laboratories, physicians, and patients. The company has developed an efficient, low-cost manufacturing process for the test, which is expected to yield high gross margins.
In summary, the FDA clearance of Biomerica’s Hp Detect Stool Antigen ELISA test marks a significant advancement in the detection and management of H. pylori infections. This development is expected to have a positive impact on the diagnosis and treatment of a large number of people suffering from this infection in the U.S.