China Food and Drug Administration (CFDA) approves Biomerica colorectal screening test to help identify the early warning signs of colorectal cancer.
Irvine, California -- January 10, 2018 -- Biomerica, Inc. (Nasdaq: BMRA) announced the China Food and Drug Administration (CFDA) approval of the EZ Detect colorectal screening test designed to help identify the early warning signs of colorectal cancer.
The EZ Detect colorectal screening test is the simplest at home test to detect fecal occult (hidden) blood, an early warning sign of colorectal cancer. The test does not require handling of stool or dietary restrictions. The EZ Detect pad is tossed into the toilet after a bowel movement. A change in the pad’s color to blue/green, which would appear within two minutes, indicates the presence of blood in the stool. The pad is then simply flushed.
With increasing incidence and mortality, cancer is the leading cause of death in China and is a major public health problem. About 376,000 new cases of colorectal cancer were reported annually in China a recent study and about 191,000 die from the disease every year1.
1 Chen et al., Cancer statistics in China, CA CANCER J CLIN 2016;66:115-132
About Biomerica (NASDAQ: BMRA)
Biomerica, Inc. (www.biomerica.com) is a global biomedical company that develops, manufactures and markets advanced diagnostic products used at the point-of-care (in home and in physicians' offices) and in hospital/clinical laboratories for the early detection of medical conditions and diseases. The Company's products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica primarily focuses on products for Gastrointestinal Disease, Diabetes and esoteric testing.
The Biomerica InFoods IBS product identifies patient specific foods that when removed may alleviate an individual's IBS symptoms. This patent-pending, diagnostic-guided therapy is designed to allow for a patient specific, guided dietary regimen to improve Irritable Bowel Syndrome (IBS) outcomes. The point-of-care product is being developed to allow physicians to perform the test in-office using a finger stick blood sample while a clinical lab version of the product will be the first for which the company will seek regulatory approval. A billable CPT code that can be used by both clinical labs and physicians' offices is available for InFoods diagnostic products. Since the InFoods product is a diagnostic-guided therapy, and not a drug, it has no drug type side effects.
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