Biomerica Receives First Commercial Order for its H. pylori test (Hp Detect™) from One of the Largest Clinical Laboratory Chains in Europe

Biomerica (Nasdaq: BMRA) received its first commercial order for Hp Detect™, a stool antigen test for Helicobacter pylori, from one of Europe’s largest clinical laboratory chains.

Rhea-AI Summary

Biomerica (Nasdaq: BMRA) received its first commercial order for Hp Detect™, a stool antigen test for Helicobacter pylori, from one of Europe’s largest clinical laboratory chains. The initial order targets the United Kingdom, where Hp Detect™ gained MHRA registration in February 2026.

Company says the account is a strategic reference customer with potential for recurring orders and wider EU distribution as Hp Detect™ is integrated into routine testing workflows, supported by NHS UK guidance recommending H. pylori testing for dyspepsia patients.

Positive

• MHRA registration secured in February 2026 for the UK market
• First commercial order from a major European lab chain for UK distribution
• Customer positioned as a reference account with expected recurring orders and EU gateway potential

Negative

• Initial commercial activity is limited to the UK, with broader EU rollout still pending

Argus Mar 18 session

+2.88% close to close Open Argus

Details

News Market Reaction – BMRA

On Mar 18, the day this news came out, BMRA closed 2.88% above the previous close.

Data tracked by StockTitan Argus for the Mar 18 session.

Key Figures

H. pylori prevalence: 45% Antibiotic-resistant list: 16 bacteria Gastric cancer rank: Third +5 more

H. pylori prevalence

45%

Estimated infection rate across Europe’s five largest countries

Antibiotic-resistant list

16 bacteria

WHO list of antibiotic-resistant bacteria posing greatest threat

Gastric cancer rank

Third

Third most common cause of cancer-related death globally

Current share price

$2.08

Price prior to publication of this news

Price change

4%

1-day move prior to news publication

52-week high discount

64.85%

Price below 52-week high before this news

52-week low premium

11.44%

Price above 52-week low before this news

Market cap

$6,040,134

Market capitalization before the news

Historical Context

5 past events · Latest: Mar 05

5 events

1. Mar 05

   Regulatory clearance

   24h Move

   -3.0%

   MHRA registration allowing hp+detect™ commercial sales in Great Britain.

2. Feb 26

   Clinical data update

   24h Move

   -5.1%

   Real-world inFoods IBS data showing strong pain and bloating reductions.

3. Feb 18

   International approval

   24h Move

   +0.0%

   Vietnam approval for EZ Detect™ nationwide distribution via major distributor.

4. Jan 14

   Earnings results

   24h Move

   -0.6%

   Q2 FY2026 results with lower revenue and focus on higher-margin products.

5. Dec 23

   Reimbursement win

   24h Move

   +10.6%

   CMS sets $300 Medicare payment rate for inFoods IBS with new PLA code.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

helicobacter pylori, h. pylori, stool antigen test, class 1 carcinogen, +4 more

8 terms

helicobacter pylori medical

"its Helicobacter pylori (H. pylori) diagnostic stool antigen test"

Helicobacter pylori is a curved bacterium that lives in the stomach and can cause long‑lasting inflammation, peptic ulcers and higher risk of stomach cancer. For investors it matters because the bacterium’s widespread infection drives demand for tests, treatments, antibiotics and potential vaccines, affecting clinical trial activity, regulatory approvals and sales—like a persistent leak that creates ongoing repair costs and market opportunities.

h. pylori medical

"H. pylori affects an estimated 45% of the population"

A common stomach bacterium that can live in the lining of the stomach and upper intestine, often causing chronic inflammation, sores (ulcers), and increasing the risk of stomach cancer. For investors, H. pylori matters because testing, treatments and vaccines create ongoing markets for diagnostics, pharmaceuticals and public-health programs, and shifts in infection rates, drug resistance or new therapies can change revenue and regulatory risk for companies in those areas.

stool antigen test medical

"its Helicobacter pylori (H. pylori) diagnostic stool antigen test"

A stool antigen test is a laboratory check that looks for proteins from bacteria, viruses or parasites in a patient’s feces to confirm an active gut infection rather than past exposure. Investors pay attention because these tests determine demand for diagnostic kits, shape clinical use and reimbursement decisions, and affect revenue and regulatory prospects for companies that develop or sell diagnostic platforms—like a smoke detector signaling a current problem instead of old damage.

class 1 carcinogen medical

"The WHO designates H. pylori as a Class 1 carcinogen"

A class 1 carcinogen is a label used by health authorities for a substance or agent with strong scientific proof that it can cause cancer in humans. For investors, this designation is a clear risk signal—like a red recall sticker on a product—because it can prompt stricter regulation, product bans, costly liability claims, cleanup expenses, or damage to a company’s reputation that may affect sales, costs, and share value.

antibiotic-resistant bacteria medical

"lists it among the 16 antibiotic-resistant bacteria posing the greatest threat"

Bacteria that no longer respond to standard antibiotic drugs, meaning medicines that used to kill them or stop their growth are less effective or useless. For investors, this matters because rising resistance can raise healthcare costs, shorten drug lifespans, spur demand for new treatments or diagnostics, and influence regulation and hospital spending—like locks changing so old keys no longer open doors, prompting a market for new keys and services.

medicines and healthcare products regulatory agency regulatory

"registration from the UK Medicines and Healthcare products Regulatory Agency (MHRA)"

A medicines and healthcare products regulatory agency is a government body that assesses, licenses and monitors the safety, effectiveness and quality of medicines, vaccines and medical devices before and after they reach the market. For investors, its decisions act like a building inspector’s approval — they determine whether a product can be sold, the timing and scope of market access, and can therefore quickly affect a company’s revenue prospects, costs and valuation.

national health service medical

"the National Health Service (NHS) guidelines recommend testing and treating H. pylori"

A national health service is a government-funded system that provides healthcare services to all residents, often financed through taxes. It ensures that people can access medical care without direct payment at the point of use, similar to public education or transportation. For investors, it highlights a country's commitment to healthcare access, which can influence government spending, economic stability, and the demand for related services and products.

dyspepsia medical

"recommend testing and treating H. pylori in patients presenting with dyspepsia"

Dyspepsia is persistent or recurrent discomfort in the upper abdomen—think of a nagging, bloated, or burning feeling after eating that won’t go away. For investors, it matters because its frequency, severity, and response to treatments affect the market for medications, clinical trial design and outcomes, regulatory approvals, and healthcare costs, similar to how a common consumer complaint can reshape demand for a household product.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• First Commercial Order by Large Lab Chain: Biomerica has received its first commercial order for Hp Detect™, from one of the largest clinical laboratory chains operating across Europe.
• Strategic Account: This new lab’s scale and geographic reach across Europe positions it as a reference account and potential gateway to broader EU laboratory channel adoption.
• Repeat Order Potential: Based on the nature of the relationship, Biomerica believes this initial order will result in recurring orders as Hp Detect™ is integrated into the customer’s routine testing workflow.
• Disease Burden: H. pylori affects an estimated 45% of the population across Europe’s five largest countries. The WHO designates H. pylori as a Class 1 carcinogen and lists it among the 16 antibiotic-resistant bacteria posing the greatest threat to human health globally.

IRVINE, Calif., March 18, 2026 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical diagnostic and therapeutic products, today announced it has received its first commercial order for Hp Detect™, its Helicobacter pylori (H. pylori) diagnostic stool antigen test, from one of the largest clinical laboratory chains operating across Europe. The initial order is for the United Kingdom market, where Hp Detect™ received registration from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in February 2026.

Commercial Significance

This commercial order represents a significant step in Biomerica’s commercialization of Hp Detect™ throughout Europe. The customer’s position as one of the leading clinical laboratory networks in Europe provides Biomerica with a high-profile account that the Company believes will support future distribution discussions across the broader EU market.

An order from a customer of this scale — secured on the strength of the product’s performance— demonstrates that Hp Detect™ meets the rigorous standards of the professional laboratory market and strengthens the Company’s position as it pursues additional distribution relationships in the US, and across the European market.

“This commercial order by one of Europe’s largest laboratory chains is a milestone for Biomerica and a meaningful commercial validation of Hp Detect™,” said Zack Irani, Chief Executive Officer. We believe this relationship will grow as Hp Detect™ becomes embedded in their routine testing workflow. We also see this as a reference point as we pursue additional partnerships in the US and across the European market.”

Market Opportunity

H. pylori is one of the most prevalent bacterial infections worldwide, estimated to infect 45% of the population across Europe’s five largest countries. It is the strongest known risk factor for gastric cancer — the third most common cause of cancer-related death globally — and is designated by the WHO as a Class 1 carcinogen. The WHO also lists H. pylori among the 16 antibiotic-resistant bacteria posing the greatest threat to human health, increasing the urgency for accurate, timely diagnostics to guide appropriate treatment.

In the United Kingdom, the National Health Service (NHS) guidelines recommend testing and treating H. pylori in patients presenting with dyspepsia and related gastrointestinal symptoms, creating a well-established and recurring clinical demand for diagnostic products such as Hp Detect™.

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.

Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain information included in this press release contains statements that are forward-looking, including statements relating to the Company’s expectations regarding repeat orders from the referenced customer, future commercial relationships with distribution partners in the US, the UK and broader European market, the potential for this initial order to serve as a reference account for future sales, the Company’s international commercialization strategy for Hp Detect™, future sales of the Hp Detect product, demand for the Company’s products, and the possible success of our products in the market. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: the customer’s decision whether to place additional orders; demand for Hp Detect™ from the referenced laboratory chain or network and other prospective customers; the Company’s ability to secure additional distribution agreements in the US, the UK and EU; regulatory approvals necessary prior to commercialization in additional countries; availability of the Company’s test kits; capacity, resource and supply chain constraints; competition from other diagnostic products and from competitors with significantly greater financial and other resources; and the Company’s ability to comply with applicable regulations in the markets where its products are sold; future total revenues and profitability from the Hp Detect product. Accordingly, such 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.

Investor Contact: Zack Irani | 949-645-2111 | investors@biomerica.com
Source: Biomerica, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Biomerica announce about Hp Detect and UK market entry (BMRA, March 18, 2026)?

Biomerica announced its first commercial order for Hp Detect targeting the UK market. According to Biomerica, Hp Detect received MHRA registration in February 2026 and the order comes from a large European laboratory chain, marking initial commercial traction.

How significant is the MHRA registration for Biomerica's Hp Detect (BMRA)?

MHRA registration enables UK commercialization and clinical use. According to Biomerica, the February 2026 registration cleared Hp Detect for the UK, supporting distribution to NHS-recommended testing pathways and professional laboratories across the country.

Does the Biomerica commercial order indicate recurring revenue for Hp Detect (BMRA)?

The company expects recurring orders as integration proceeds within the lab's workflow. According to Biomerica, the laboratory’s scale and routine testing use make repeat purchasing likely as Hp Detect becomes embedded in diagnostic protocols.

What market opportunity did Biomerica cite for Hp Detect in Europe (BMRA)?

Biomerica highlighted high H. pylori prevalence across Europe’s largest countries and NHS testing guidance. According to Biomerica, H. pylori infects about 45% of the population across those five countries, driving clinical demand for diagnostics.

Will the first European order for Hp Detect lead to wider EU distribution (BMRA)?

Biomerica views the order as a strategic reference point for EU expansion. According to Biomerica, the customer’s geographic reach and reputation could support broader distribution discussions across the European market and future partnerships.