Egyptian Drug Authority Authorizes Biomerica’s Complete Screening Test Portfolio
Rhea-AI Summary
Biomerica (Nasdaq: BMRA) announced on Dec 11, 2025 that the Egyptian Drug Authority authorized its complete portfolio of rapid screening tests for marketing and distribution in Egypt.
The authorization covers at‑home and point‑of‑care tests for colorectal disease, breast self exam, prostate (PSA), kidney (microalbumin) and H. pylori, offering results in minutes without lab processing to support mass screening and individual use across Egypt and the MENA region.
Positive
- Regulatory authorization by Egyptian Drug Authority on Dec 11, 2025
- Full portfolio cleared: 5 screening tests for CRC, breast, prostate, kidney, H. pylori
- No lab processing required enabling point‑of‑care and at‑home mass screening
- Targets high‑need populations in Egypt where CKD prevalence is ~13% and H. pylori prevalence is 50–70%
Negative
- None.
News Market Reaction
On the day this news was published, BMRA gained 3.20%, reflecting a moderate positive market reaction. Argus tracked a peak move of +12.6% during that session. Argus tracked a trough of -11.9% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $229K to the company's valuation, bringing the market cap to $7M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Peers show mixed moves, from -5% (SSKN) and -4.9% (HSCS) to a strong gain of +29.8% (RSLS), with no broad, unified sector trend to frame BMRA’s Egypt screening test authorization.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 25 | Clinical data feature | Positive | +4.4% | inFoods IBS trial results highlighted in Biotherapeutics Quarterly. |
| Nov 06 | CDMO expansion | Positive | -1.2% | Expansion of CDMO services to meet rising diagnostics demand. |
| Oct 16 | Commercial partnership | Positive | +5.2% | Henry Schein marketing agreement for inFoods IBS across U.S. |
| Oct 15 | Earnings update | Negative | -0.7% | Q1 FY2026 results with lower sales and going-concern disclosure. |
| Oct 08 | Board appointment | Positive | +1.4% | Appointment of former LabCorp Diagnostics CEO Gary Huff to board. |
Recent news has been mostly positive (commercial deals, clinical data, board additions), with share reactions generally modest and more often aligned than divergent with the apparent news tone.
Over the last few months, Biomerica reported Q1 FY2026 results showing lower net sales but improved margins and a near break-even bottom line, while also disclosing going-concern risk. The company expanded CDMO services and secured a U.S. marketing agreement with Henry Schein for inFoods® IBS, backed by positive clinical data. Board strength was enhanced through the appointment of Gary Huff. Today’s Egyptian Drug Authority authorization extends the theme of global commercialization and broader access for its diagnostic portfolio.
Market Pulse Summary
This announcement authorizes Biomerica’s full rapid screening portfolio in Egypt, covering colorectal, breast, prostate, kidney disease, and H. pylori tests. It extends prior regulatory wins and supports the company’s strategy of point‑of‑care, infrastructure‑light diagnostics for large at‑risk populations. Recent filings highlighted weaker sales and going‑concern risk, so investors may watch how quickly this authorization converts into orders, reimbursement pathways, and any follow-on agreements with local healthcare systems or distribution partners.
Key Terms
fecal occult blood test medical
FOBT medical
Helicobacter pylori medical
Prostate Specific Antigen medical
PSA medical
age-standardized incidence rate medical
chronic kidney disease medical
lateral flow test medical
AI-generated analysis. Not financial advice.
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
H. pylori infection in Egypt is highly prevalent; studies report varying prevalences between 50 to
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
FAQ
What did Biomerica (BMRA) receive from the Egyptian Drug Authority on Dec 11, 2025?
Which Biomerica (BMRA) tests are authorized in Egypt and what do they detect?
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How does the Biomerica (BMRA) authorization address public‑health needs in Egypt?
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