Vietnam Approves Biomerica’s EZ Detect™ for Nationwide Distribution
Rhea-AI Summary
Biomerica (Nasdaq: BMRA) announced that Vietnam’s Hanoi Department of Health approved EZ Detect™ for nationwide sales and distribution on Feb 18, 2026. The FDA-cleared, two-minute at-home colorectal screening test will be sold via a major distributor across pharmacies, hospitals, clinics, and online channels.
The approval targets Vietnam’s high unmet need: 16,835 new colorectal cancer cases in 2022 and a reported 45% five-year survival rate, versus 91% when detected early in the US.
Positive
- Regulatory approval for nationwide Vietnam distribution (Hanoi Department of Health)
- FDA-cleared two-minute at-home colorectal screening test
- Clinical preference 92% patient preference in Johns Hopkins study (10 of 11 patients)
- Addresses large unmet need: Vietnam 16,835 new CRC cases in 2022 and 45% five-year survival
- Distribution channels include pharmacies, hospitals, physician offices, and online sales
Negative
- None.
News Market Reaction – BMRA
On the day this news was published, BMRA declined NaN%, reflecting a moderate negative market reaction. Argus tracked a peak move of +2.0% during that session. Argus tracked a trough of -12.9% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Sector peers were mixed: some up (e.g., LFWD, SSKN earlier in the day) and others down, while momentum data show SSKN down 14.8%. With BMRA down 2.62% and only one peer in the momentum scan, trading appears more stock-specific than sector-driven.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| 2026-01-14 | Q2 earnings | Negative | -0.6% | Weaker sales, losses and going concern language pressured shares modestly. |
| 2025-12-23 | Medicare pricing | Positive | +10.6% | CMS set a <b>$300</b> Medicare rate and CPT code for inFoods IBS. |
| 2025-12-11 | Egypt approval | Positive | +3.2% | Egyptian Drug Authority authorized full screening test portfolio for distribution. |
| 2025-11-25 | Clinical publication | Positive | +4.4% | InFoods IBS trial data featured in Biotherapeutics Quarterly highlighted strong response rates. |
| 2025-11-06 | CDMO expansion | Positive | -1.2% | Announced expanded CDMO services, but shares slipped despite broader capabilities. |
BMRA has generally reacted positively to operational and partnership news, while financial reports with weaker results or going concern language have seen mild pressure.
Over the past six months, Biomerica has issued several growth-focused updates. Regulatory and market-access wins, such as the CMS $300 Medicare rate for inFoods IBS and multi-country test authorizations (e.g., Egypt on Dec 11, 2025), drew positive price reactions. By contrast, the Q2 FY2026 results on Jan 14, 2026 highlighted weaker sales and going-concern risk and were followed by a small decline. Today’s Vietnam approval continues the theme of international expansion for its screening portfolio.
Market Pulse Summary
This announcement adds another international milestone to Biomerica’s portfolio, with EZ Detect™ now cleared for nationwide distribution in Vietnam, a country of over 100 million people facing rising colorectal cancer incidence and a reported 45% five-year survival rate. The news builds on earlier authorizations in markets like Egypt and reimbursement wins for inFoods IBS. Investors may focus on how quickly this approval converts into meaningful revenue, given recent 10-Q disclosures of weaker sales, losses, and going-concern risk.
Key Terms
fda-cleared regulatory
colorectal cancer medical
occult blood medical
fecal occult blood test medical
randomized clinical trial medical
colonoscopY medical
AI-generated analysis. Not financial advice.
- Approval Marks Biomerica’s Strategic Entry into Southeast Asia’s Rapidly Growing Healthcare Market
- Simple, FDA-Cleared At-Home Test Detects an Early Warning Sign of Colorectal Cancer in Minutes
IRVINE, Calif., Feb. 18, 2026 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced diagnostic solutions, announced that Vietnam’s Hanoi Department of Health has officially approved the EZ Detect™ colorectal disease at-home screening test for sales and distribution throughout Vietnam. Biomerica is working with a major healthcare products distributor in Vietnam who will manage the sales and distribution of the product through pharmacies, hospitals, physician’s offices, and direct online sales channels.
EZ Detect™ is an FDA-cleared two-minute at-home screening test designed to detect an early warning sign of colorectal cancer and other colorectal diseases. This regulatory approval represents a milestone in Biomerica’s strategic global expansion into Southeast Asia, a region with over 680 million people and rapidly growing healthcare spending.
Addressing a Critical Public Health Need in Vietnam
Colorectal cancer (“CRC”) is a growing public health crisis in Vietnam, a nation of over 100 million people. According to the most recent 2022 data, Vietnam recorded 16,835 new cases of colorectal cancer, making it the fourth most common cancer in the country, accounting for
Key Benefits of EZ Detect™
- Early Detection: EZ Detect™ identifies occult (hidden) blood in the stool which can be an early indicator of colorectal diseases, including cancer. Early detection is the single most important factor in improving colorectal cancer survival outcomes.
- User-Friendly and No Stool Handling: The test requires no special preparation or dietary restrictions. Unlike competing tests, EZ Detect™ does not require a person to touch or handle stool and can be completed in the privacy of one’s home without the unpleasantness of handling and mailing stool samples to a laboratory.
- Accessible and Affordable: EZ Detect™ offers an accessible and convenient option toward early detection - without the need for clinical visits, laboratory processing or expensive equipment.
- Clinically Validated with Superior Patient Compliance: In a study performed by Johns Hopkins University, approximately 10 out of 11 patients preferred EZ Detect™ over a conventional fecal occult blood test (
92% vs.8% ). Published research has indicated that the best colorectal screening test is “the one that gets done.” Because competing tests require handling and mailing stool samples, a significant percentage of those tests are never completed by patients, dramatically reducing their real-world effectiveness. - Lower Healthcare Costs: Regular screening with EZ Detect™ can help detect potential issues before they become more serious, potentially saving healthcare systems significant costs associated with late-stage cancer treatment.
A Large and Growing Global Market Opportunity
Colorectal cancer is one of the most prevalent and potentially life-threatening conditions worldwide. According to the World Health Organization (WHO) and the GLOBOCAN 2022 database, approximately 1.93 million new cases of colorectal cancer and more than 900,000 deaths due to colorectal cancer were estimated to have occurred worldwide in 2022. Colorectal cancer is the third most common cancer globally and is the second leading cause of cancer-related death worldwide. These figures are projected to rise significantly by 2050, driven by aging populations and lifestyle changes, particularly in developing nations throughout Southeast Asia, Africa, and Latin America.
How EZ Detect™ Works
The EZ Detect™ test offers a simple and convenient solution for individuals to test for colorectal disease in the comfort of their own homes. A person simply places an EZ Detect™ test pad on top of toilet water after a bowel movement. A change in the test 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 down the toilet. Patients who see a positive result record it and then should consult with their physician for next steps.
According to the American Cancer Society, colorectal cancer detected early while still localized has a five-year survival rate of approximately
“This approval is a milestone in Biomerica’s global expansion and represents a meaningful opportunity to save lives in a region with high unmet need and growing commitment to improving healthcare access.,” said Zack Irani, CEO of Biomerica. “We are committed to working with our distribution partner to ensure this tool reaches as many Vietnamese citizens as possible. This approval also serves as a template for expansion across additional Southeast Asian markets. Access to simple, at-home screening tests is an important step towards saving lives around the world, and we remain dedicated to our mission of providing easier access to healthcare solutions that make a real difference.”
For further information about the EZ Detect™ product, please visit https://ezdetect.com/
References
[1] GLOBOCAN 2022, International Agency for Research on Cancer (IARC) – Global and Vietnam-specific colorectal cancer incidence, mortality, and ranking data.
[2] Pham T, et al. Overall Survival Rate of Vietnamese Patients with Colorectal Cancer: A Hospital-Based Cohort Study in the Central Region of Vietnam. Cancer Control. 2022;29. PMC9068178.
[3] SEER Cancer Statistics / American Cancer Society – Five-year relative survival for localized colorectal cancer:
[4] Cruz-Correa M, et al. Performance Characteristics and Comparison of Two Fecal Occult Blood Tests in Patients Undergoing Colonoscopy. Dig Dis Sci. 2007;52:1009–1013.
[5] Inadomi JM, et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012;172(7):575–582.
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, cost of goods, operations and earnings, efficacy of the Company’s products and tests including the EZ Detect™ colorectal disease Test (“EZ Detect”), FDA and/or international regulatory authorization for the Company’s products to be marketed and sold, including EZ Detect, and the Company’s other current and future products, the possible expansion in to other markets, uniqueness of the Company’s EZ Detect Test and other products, accuracy of the Company’s EZ Detect Test and other products, pricing of the Company’s test kits, domestic and/or international market adoption and acceptance and demand for the Company’s products including the EZ Detect Test, the availability of product in pharmacies, clinics, and hospitals, future use of the Company's products by physicians to treat their patients, potential revenues from the sale of current or future products. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, in the future, including, without limitation: earnings and other financial results; results of studies testing the efficacy of the Company’s EZ Detect Test and other products such as the inFoods IBS tests and other products; regulatory approvals necessary prior to commercialization of the Company’s products; availability of the Company’s test kits and other products; capacity, shipping logistics, resource and other constraints on our suppliers; dependence on our third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for our various tests and other products; competition from other similar products and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that make it difficult or impossible for the company to maintain current operations; regulatory compliance and oversite, and the Company’s ability to obtain patent protection on any aspects of its diagnostic or therapeutic technologies. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Additionally, potential risks and uncertainties include, among others, fluctuations in the Company's operating results due to its business model and expansion plans, downturns in international and or national economies, the Company's ability to raise additional capital, the competitive environment in which the Company will be competing, and the Company's dependence on strategic relationships. 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) announce about EZ Detect™ on February 18, 2026?
How does EZ Detect™ work and how quickly does it deliver results in BMRA's Vietnam launch?
What Vietnam colorectal cancer data did Biomerica cite in the BMRA announcement?
Does the BMRA press release state clinical evidence or patient preference for EZ Detect™?
What channels will distribute EZ Detect™ in Vietnam under Biomerica's plan?
How might BMRA’s Vietnam approval affect Biomerica’s Southeast Asia expansion plans?
