Biomerica Shares Rise After FDA 510(k) Clearance for H Pylori Bacteria Test

By Sabela Ojea

Shares of Biomerica surged Monday after the company said it received 510(k) clearance for its Hp detect stool antigen Elisa test, a new product set to detect the H pylori bacteria.

At 11:40 a.m. ET, shares were up 61% at $1.59. The stock has, however, dropped 58% in the past 12 months.

The biomedical technology company said more than 80% gastric cancers are associated with H. pylori infection, noting that gastric cancer is the third most common cause of cancer-related death on a worldwide basis.

The bacteria infects about 35% of the U.S. population, Biomerica added.

The 510(k) program accounts for most new medical devices the FDA reviews to reasonably assure their safety and effectiveness, according to the FDA's website.

Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix

(END) Dow Jones Newswires

December 18, 2023 12:10 ET (17:10 GMT)

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