The test is designed to increase sensitivity and specificity of H. pylori testing.
Here’s what you should know:
1. The company is conducting a multisite study at Los Angeles-based University of Southern California, Nashville, Tenn.-based Vanderbilt University and at a European University.
2. Biomerica believes the study will take between six months to a year to complete.
3. After the study is complete, Biomerica will conduct analysis in anticipation of submitting the test to the FDA. Biomerica believes it’ll be able to utilize a 510(k) pathway clearance.
4. Biomerica CEO Zackary Irani said in a release the new product answers demand for an accurate and cost-effective test.
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