Egyptian Drug Authority Authorizes Biomerica’s Complete Screening Test Portfolio

Authorization Covers Multiple Screening Tests for Cancer and Chronic Disease Risk Detection

• Portfolio includes tests for colorectal disease, breast self exam, prostate disease, kidney disease, and H. pylori infection

• Designed for early detection of conditions that are related to the most common cancers and chronic diseases

• Rapid, easy-to-use, and cost-effective screening for mass and individual use

IRVINE, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced diagnostic solutions, announced today that the Egyptian Drug Authority (EDA) has granted authorization for Biomerica’s complete portfolio of rapid tests, enabling broad access to simple, rapid, and affordable early detection tools for conditions associated with cancers and chronic diseases across Egypt.

This authorization allows Biomerica’s screening products to be marketed and distributed throughout Egypt, supporting early identification of conditions associated with colorectal, breast, and prostate cancers, as well as chronic diseases including kidney disease and Helicobacter pylori infection.

Comprehensive Screening Portfolio Now Authorized in Egypt

The EDA authorization covers the following Biomerica at-home tests:

EZ Detect™ Colon Disease Test – The most convenient fecal occult blood test (FOBT) that detects hidden blood in stool, an early warning sign of colorectal diseases such as polyps and colorectal cancer. Results are available within two minutes, with no stool handling required.
Aware^® Breast Self Exam – An aid designed to enhance breast self examination by improving tactile sensitivity and allowing users to detect changes in breast tissue more effectively, supporting early detection of breast abnormalities, including potential indicators of cancer.
Fortel Prostate (PSA) Screening Test – A rapid lateral flow test using a finger-prick whole blood sample to detect elevated Prostate Specific Antigen (PSA) levels, which may indicate prostate disease including prostate cancer.
Fortel Kidney Disease (Microalbumin) Screening Test – Detects elevated levels of human albumin in urine, an early marker of possible kidney damage, supporting early identification of chronic kidney disease risk.
Fortel Ulcer (H. pylori) Screening Test – A rapid whole blood test detecting antibodies to Helicobacter pylori infection, which is associated with gastritis, ulcers, and in some cases stomach cancer.

All tests are designed for point-of-care use enabling deployment across diverse clinical and community settings, including regions with limited infrastructure. They provide quick results within minutes, and eliminate the need for laboratory sample processing, reinforcing Biomerica’s commitment to accessible preventive healthcare.

A Significant Unmet Need in Egypt for Screening

Colorectal Cancer (CRC) is a moderately common cancer in Egypt (7th most common) with roughly 5 – 10 cases per 100,000 persons per year, with rising diagnoses at younger ages and a high proportion of cases detected at late stages.

According to the International Agency for Research on Cancer (IARC)/Global Cancer Observatory (GLOBOCAN) the age-standardized incidence rate (ASR, world standard) for breast cancer in females is about 55.4 per 100,000 persons per year. Breast cancer is the most common cancer among women in Egypt by incidence. The mortality outcomes are comparatively worse, which are influenced by later stage at diagnosis as screening and early detection are less prevalent than in high-income countries.

Prostate Cancer is the fourth most common cancer in Egypt with increasing incidence.

Research shows that approximately 13% of adults in Egypt are living with chronic kidney disease according to a population analysis published in the Journal of Public Health in Africa. Additionally, CKD ranked among the top five causes of death in Egypt from 2009 to 2019, highlighting the severity and increasing burden of the disease.

H. pylori infection in Egypt is highly prevalent; studies report varying prevalences between 50 to 70%, likely affecting a majority of children and many adults.

Strengthening Egypt’s Preventive Healthcare Infrastructure

These screening tools target populations most at risk, including individuals with diabetes, hypertension, family histories of cancer, and other chronic health conditions. By empowering individuals with private, reliable, and rapid home testing, these products support national public health efforts to shift disease detection earlier, improve outcomes, and reduce long-term healthcare costs.

“Authorization of our full screening portfolio by the Egyptian Drug Authority represents a milestone in expanding access to early detection in a region with growing chronic disease and cancer burdens,” said Zack Irani, CEO of Biomerica. “This authorization provides scalable tools for both individual testing and screening initiatives.”

Designed for Population-Level Screening

Biomerica’s screening tests are positioned not only for consumer use but also for public health campaigns, clinics, pharmacies, and hospital-based screening programs, offering:

No lab processing or mailing requirements
Low-cost, scalable solutions for mass screening
Quick turnaround for immediate decision-making
Privacy and convenience for patients

These features allow healthcare providers and government agencies to deploy large-scale screening programs efficiently, particularly in underserved and rural areas.

Expanding Biomerica’s Presence in the Middle East & North Africa

This authorization strengthens Biomerica’s strategic expansion across the Middle East and North Africa (MENA) region and reinforces its role as a provider of affordable, patient-centered diagnostic solutions aligned with global preventive care trends.

About Biomerica (NASDAQ: BMRA)

Biomerica, Inc. (www.biomerica.com) is a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in home and in physicians' offices) and in hospital/clinical laboratories for detection and/or treatment 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 gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development.

The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other written statements made or to be made by Biomerica) contains statements that are forward-looking, such as statements relating to the Company’s current and future sales, revenues, overhead, expenses, operations, margins, cost of goods, and earnings; the efficacy, performance, and potential market adoption of the Company’s products and tests, including but not limited to the EZ Detect™ Colon Disease Test, Aware^® Breast Self Exam, Prostate (PSA) screening Test, Fortel^® Kidney Disease (Microalbumin) Test, H. pylori screening Test, and the Company’s broader screening test portfolio; the Company’s ability to obtain and maintain regulatory authorizations, clearances, or approvals necessary to market or sell any of its current or future products; the Company’s ability to expand into additional domestic or international markets; the uniqueness, clinical utility, accuracy, potential benefits, and commercial acceptance of the Company’s products; pricing of the Company’s test kits; domestic and/or international demand for the Company’s products; future availability of the Company’s products in pharmacies, clinics, hospitals, or through public health programs; and the potential use of the Company’s products by physicians and healthcare organizations. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, including, without limitation: results of studies testing the efficacy or performance of the Company’s products; regulatory requirements and the ability to obtain or maintain necessary approvals; supply-chain challenges and dependence on third-party manufacturers and shipping carriers; governmental import/export regulations; competitive products and companies with significantly greater financial and operational resources; governmental healthcare policies; demand for the Company’s various tests; pricing pressures; reimbursement challenges; the Company’s ability to raise additional capital; general economic conditions; and the Company’s ability to protect its intellectual property. Accordingly, actual results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. The Company is under no obligation to update any forward-looking statements after the date of this release.

Corporate Contact:
Zack Irani | CEO
p. 949.645.2111
www.biomerica.com

Source: Biomerica

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