Biomerica Stock Price, News & Analysis

Biomerica, Inc. is a biomedical technology company that develops, manufactures, and commercializes advanced medical diagnostic products and therapeutic solutions used at the point-of-care, in clinical laboratories, and through direct-to-consumer channels. The company specializes in diagnostic test kits that analyze blood, urine, nasal, or fecal specimens to detect various diseases, food intolerances, and other medical conditions. These tests measure levels of specific bacteria, hormones, antibodies, antigens, and other substances that may exist in the human body in extremely small concentrations.

Core Business Focus

Biomerica's primary focus centers on gastrointestinal and inflammatory diseases, where the company has developed multiple diagnostic and therapeutic products. The company's diagnostic portfolio addresses conditions including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), colorectal disease, food intolerances, and various other gastrointestinal disorders. Additionally, Biomerica manufactures screening tests for kidney disease, breast cancer, prostate disease, and Helicobacter pylori (H. pylori) infection.

Gastrointestinal Diagnostics

The inFoods® IBS test represents one of the company's flagship products, designed specifically for patients suffering from irritable bowel syndrome. This blood-based diagnostic identifies specific foods that trigger elevated Immunoglobulin G (IgG) antibody responses, which serve as markers of inflammation associated with IBS symptoms. By identifying individual trigger foods, the test enables personalized dietary interventions that may provide significant symptom relief. Clinical studies evaluating the inFoods® IBS test have been conducted at prominent medical institutions and published in peer-reviewed gastroenterology journals. The company has also developed the inFoods® IBS Trigger Food Navigator, an AI-powered digital tool that helps patients manage their IBS symptoms by providing meal suggestions and ingredient substitutions based on their personalized trigger food profile.

For inflammatory bowel disease patients, Biomerica offers food intolerance tests targeting Crohn's disease and ulcerative colitis. These diagnostic products have received IVDR (In Vitro Diagnostic Regulation) certification and CE-marking under the European Union's regulatory framework, enabling their distribution throughout European markets.

Colorectal and Cancer Screening

The EZ Detect™ colorectal disease screening test provides an FDA-cleared at-home testing option for early detection of colorectal disease. The test offers several advantages as a screening tool: it requires no stool handling, imposes no diet restrictions, and delivers results at home within minutes. The product is distributed through major retail pharmacy chains and is available both in-store and online. Colorectal cancer ranks as the second most common cause of cancer death in the United States, making accessible screening tests an important component of preventive healthcare.

Biomerica also manufactures screening tests for breast cancer and prostate disease detection, expanding its oncology-focused diagnostic portfolio beyond gastrointestinal applications.

Infectious Disease Diagnostics

The company's H. pylori diagnostic product line includes both rapid lateral flow immunoassays and ELISA-based tests for detecting Helicobacter pylori bacteria in human stool samples. H. pylori infection affects a substantial portion of the global population and is associated with gastritis, peptic ulcers, and in some cases, gastric cancer. The company's hp+detect™ and EZ-H. pylori Antigen™ products have received FDA clearance and CE Mark certification for distribution in the United States and European markets. The Fortel® Ulcer (H. pylori) Screening Test offers a rapid whole blood testing option.

Kidney Disease Screening

Biomerica's Fortel® Kidney Test provides screening capabilities for chronic kidney disease detection. The test has received regulatory approval for home use in various international markets, enabling patients to screen for kidney disease in a convenient at-home setting.

Contract Development and Manufacturing Organization (CDMO) Services

In addition to its proprietary diagnostic products, Biomerica operates a Contract Development and Manufacturing Organization (CDMO) business segment that provides development and manufacturing services to biotechnology and diagnostic companies. The CDMO services cover the entire product lifecycle from initial assay development through scaled commercial manufacturing. The company maintains ISO 13485 certification, CE-mark expertise, and operates an FDA-registered cGMP (current Good Manufacturing Practice) facility.

The CDMO services include assay development and custom solutions, antibody and reagent services (including HRP antibody conjugation, biotinylation, and colloidal gold antibody conjugation), recombinant antibody development, and manufacturing and assembly services. The company specializes in lateral flow diagnostics, point-of-care diagnostics, ELISA tests, and Multiplex ELISA assays. CDMO services also encompass lateral flow cassette assembly, automated ELISA plate coating, custom lyophilization, supply chain support, and technology transfer assistance. This business segment represents a growing contributor to company revenue.

Geographic Markets and Distribution

Biomerica generates revenue from multiple geographic regions including Asia, Europe, North America, the Middle East, and South America. The majority of revenue is earned from Asian markets. The company has established distribution partnerships with major retail pharmacy chains for its consumer-facing products and maintains regulatory authorizations in numerous countries. Recent regulatory approvals include authorization from the Egyptian Drug Authority for the company's complete screening test portfolio and approval from the UAE Ministry of Health and Prevention for home use of multiple Fortel® diagnostic tests.

Regulatory and Reimbursement

Biomerica holds various regulatory clearances and certifications including FDA 510(k) clearances, CE Marks, IVDR certifications, and ISO 13485 quality management system certification. The company's products are manufactured in FDA-registered facilities that comply with cGMP requirements. For the inFoods® IBS test, the Centers for Medicare & Medicaid Services (CMS) has established a national Medicare payment rate under the Clinical Laboratory Fee Schedule (CLFS), and the American Medical Association (AMA) has approved a unique CPT® Proprietary Laboratory Analyses (PLA) code for the test.

Market Opportunity

The markets addressed by Biomerica's diagnostic products represent substantial patient populations. Irritable bowel syndrome affects approximately 10-15% of adults in the United States, representing millions of potential patients experiencing chronic symptoms including abdominal pain, bloating, diarrhea, and constipation. Inflammatory bowel diseases, colorectal cancer, H. pylori infection, and chronic kidney disease similarly affect large patient populations globally, creating demand for diagnostic screening and monitoring tools.

Manufacturing and Quality

The company operates manufacturing facilities that maintain ISO 13485 certification and FDA registration. Production capabilities include lateral flow device assembly, ELISA plate coating and processing, antibody conjugation, lyophilization services, and final product packaging and labeling. The facilities are designed to support both internal product manufacturing and contract manufacturing services for third-party clients.