Biomerica Inc BMRA has received FDA 510(k) clearance for its Hp Detect Stool Antigen ELISA test, designed to detect the presence of the H. pylori bacteria.
H. pylori infection is a disease that affects half the world's population.
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 can 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.
Biomerica's Chief Executive Officer Zack Irani stated, "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."
Price Action: BMRA shares are up 57.58% at $1.56 during the premarket session on the last check Monday.
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