BMRA - Biomerica stock rises on filing with FDA to market bacteria detection test

Biomerica (NASDAQ:BMRA) submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for hp+detect test that detects the presence of Helicobacter pylori (H. pylori) bacteria. The company said that over 80% of gastric cancers are attributed to H. pylori infection. A 510(K) is a premarket submission which shows that the device to be marketed is as safe and effective, substantially  equivalent, to a legally marketed device that is not subject to premarket approval. The company said that under the current FDA 510(k) premarket notification process, the U.S. drug regulator's goal is to make a decision within 90 days, unless further information is requested. Biomerica (BMRA) added that is preparing to submit a CE Mark filing, which will enable the product to be sold in most EU countries and other regions globally. BMRA +6.50% to $4.26 premarket April 26

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Biomerica stock rises on filing with FDA to market bacteria detection test