Biomerica

What Biomerica does

Biomerica, Inc. (NASDAQ: BMRA) is a U.S.-headquartered biomedical company that develops, manufactures, and markets in-vitro diagnostic (IVD) products, founded in 1971 and based in Irvine, California, with a secondary FDA-registered production facility in Mexicali, Mexico. The portfolio spans three product categories: (1) the flagship inFoods IBS diagnostic-guided therapy, a proprietary laboratory-developed test that measures food-specific IgG antibodies in patient blood to identify individual IBS trigger foods and support personalized elimination diets, supported by an AI-backed dietary compliance tool and real-world clinical evidence (59.6% abdominal pain reduction vs 42.1% control in multicenter studies); (2) a broad catalog of branded rapid screening tests sold OTC and at point of care (EZ Detect colorectal, Fortel line covering pregnancy, ovulation, PSA, kidney, and H. pylori); and (3) professional ELISA kits for clinical laboratories spanning food allergy panels (Allerquant), H. pylori serology and stool antigen (GAP, HP Detect, hp+detect), Type 1 diabetes autoantibodies (Isletest), and specialty hormone assays. Underlying technology is built on 30+ years of ELISA, multiplex ELISA, and lateral flow immunoassay development, recombinant antibody platforms, custom lyophilization, and automated ELISA plate coating, all manufactured under EN ISO 13485:2016 in FDA-registered cGMP facilities. The business model is hybrid: diagnostic product sales (hardware) through OTC retail pharmacy, distributors, and direct B2B; CDMO contract development and manufacturing services to third-party diagnostic and biotech clients under milestone-based Master Services Agreements (e.g., a $1.75M+ three-year MSA signed in May 2026); and a reimbursement-driven revenue stream for inFoods IBS through CLIA-certified lab partner Ethos Laboratories at a $300 CMS national Medicare rate effective January 1, 2026. The company reaches customers globally, with 80+ diagnostic products, 100+ patents filed, and recent regulatory approvals and commercial launches in the U.S., Canada, U.K., Vietnam, Egypt, the UAE, and broader Europe.

Name

Biomerica

Legal name

Biomerica, Inc.

Website

https://biomerica.com

Company type

Public

Founded year

1971

Operating status

Operating

Headcount range

51–100 employees

Short description

Biomerica, Inc. is a U.S. biomedical company that develops, manufactures, and markets in-vitro diagnostic products including the inFoods IBS diagnostic-guided therapy, a broad catalog of branded rapid screening tests, professional ELISA kits, and CDMO services, serving clinicians, clinical labs, OTC consumers, and third-party diagnostic companies.

Ownership category

akta.pro rank

Product category

In-Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical and Diagnostic Laboratories (6215), Medical and Diagnostic Laboratories (62151), Pharmaceutical and Medicine Manufacturing (3254)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Pharmaceutical Preparations (2834), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB)

akta.pro secondary industries

Clinical Chemistry & Hematology Diagnostics (automated analyzers, blood testing) (HLAAALAH), Cell-Based & Potency Assays (Bioassays) (HLAGADAH), Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)

Keywords

• In-vitro diagnostics
• ELISA assay development
• At-home diagnostic tests
• Contract diagnostic manufacturing
• Point-of-care screening tests

Headquarters

HQ city

Irvine

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain, Infrastructure

Revenue model

1. Diagnostic Product Sales: Sales of FDA-cleared and CE-marked in-vitro diagnostic products (At-Home, Point-of-Care, and Clinical Lab formats) for anemia, bone & mineral metabolism, colorectal disease, diabetes, endocrinology, food intolerance, gastrointestinal, kidney disease, men's health, and women's health. Sold through OTC retail pharmacy, distributor channels, and direct sales.
2. CDMO Contract Development Services: Contract Development and Manufacturing Organization (CDMO) services for biotechnology and diagnostic companies, including assay development, antibody services, recombinant antibody development, manufacturing, and supply chain support. Revenue recognized on milestone-completion basis (e.g., $1.75M Master Services Agreement over three years with automatic renewals).
3. inFoods IBS Lab Test Reimbursement: Reimbursement-driven revenue from inFoods IBS diagnostic test processed through Ethos Laboratories (CLIA-certified lab partner), with CMS establishing a $300 national Medicare payment rate effective January 1, 2026, under dedicated CPT Proprietary Laboratory Analyses code.
4. Equity Capital Raises: Capital raised through public stock offerings (e.g., $8 million public stock offering in March 2023 with 3,333,333 shares at $2.40 per share through Craig-Hallum Capital Group).

Pricing tiers

Go-to-market motion5 records

Distribution channels7 records

Marketing channels7 records

Core offering

Biomerica develops, manufactures, and markets advanced in-vitro diagnostic products and therapeutic products, with a primary focus on gastrointestinal and inflammatory diseases. The company sells a portfolio of FDA-cleared and CE-marked rapid screening tests (at-home, point-of-care, and clinical lab formats) including the inFoods IBS diagnostic-guided therapy platform, EZ Detect, Fortel at-home tests, and professional ELISA kits (H. pylori, Allerquant food panels, Isletest, hormone assays), and provides contract development and manufacturing (CDMO) services to biotech and diagnostic companies from FDA-licensed, ISO 13485-certified facilities in Irvine, CA and Mexicali, Mexico.

Product overview

Biomerica operates a diversified portfolio rather than a single unified product: it is a specialty diagnostics and medical device company that combines (1) a flagship diagnostic-guided therapy — inFoods IBS, backed by an AI-backed dietary compliance tool — with (2) a broad catalog of branded rapid screening tests (EZ Detect, Fortel line including Kidney, Ulcer, PSA, Ovulation, and hCG variants) and (3) a deep catalog of professional ELISA kits for clinical labs, spanning H. pylori detection (GAP IgA/IgG/IgM ELISA, HP Detect Stool Antigen, EZ-H. pylori Antigen, hp+detect), food allergy panels (Allerquant regional panels), hormone assays (ACTH, Calcitonin, EPO, PTH), and Type 1 diabetes autoantibody testing (Isletest GAD/IAA/ICA). The portfolio is complemented by consumer health products such as Aware Breast Self-Exam and by Contract Development & Manufacturing (CDMO) services for third-party diagnostics and medical device clients. The branded rapid tests serve consumer/point-of-care settings while the ELISA kits serve clinical laboratories, with overlapping disease areas (notably H. pylori and gastroenterology) and a shared regulatory pathway (ISO 13485, FDA, CE, cGMP).

Differentiator

Problem solved

Functional benefit

Brands

• inFoods IBS: Diagnostic-guided therapy platform identifying patient-specific food triggers that contribute to irritable bowel syndrome (IBS) symptoms.
• EZ Detect
• Fortel
• Allerquant
• GAP (H. pylori)
• Isletest
• Aware
• HP Detect
• hp+detect

Products and services

• inFoods IBS
• EZ Detect
• Fortel Kidney Disease (Microalbumin) Screening Test
• Fortel Ulcer (H. pylori) Test
• Fortel Prostate (PSA) Test
• Fortel Ovulation Test
• Fortel hCG Cassette
• Fortel Ultra Midstream hCG
• EZ-H. pylori Antigen (Professional)
• EZ-hCG Cassette (Professional)
• EZ-LH (Professional)
• EZ-PSA (Professional)
• hp+detect H. pylori Diagnostic Test
• HP Detect Stool Antigen ELISA
• GAP H. pylori IgA / IgG / IgM ELISA
• Allerquant ELISA Panels
• Isletest ELISA (GAD, IAA, ICA)
• ACTH / Calcitonin / EPO / PTH (Intact) ELISA
• Aware Breast Self-Exam
• Contract Development & Manufacturing (CDMO) Services

Quantifiable outcome

• 59.6% of treatment group patients achieved FDA endpoint for abdominal pain reduction vs 42.1% in control (real-world study)
• +7 more outcomes

Named customers5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature7 records

Partnerships

Nine partnerships are on record, tiered core, minor and flagship.

• Undisclosed life sciences company (CDMO client)coreStrategic or Co-development Partner · 28 May 2026Confidential life sciences company entered into a three-year Master Services Agreement with Biomerica for proprietary in vitro diagnostic assay development at Biomerica's FDA-licensed, ISO 13485-certified Irvine facility. Initial contract development target fee over $1.75 million with automatic one-year renewals and milestone-completion revenue recognition.
• Phoenix Airmid BiomedicalcoreChannel Partner/ Reseller/ Distributor · 14 April 2026Phoenix Airmid Biomedical serves as the exclusive distributor for Biomerica's inFoods IBS diagnostic-guided therapy platform in Canada. Represents Biomerica's first commercial entry into the Canadian market.
• CanAlt Health LabscoreChannel Partner/ Reseller/ Distributor · 14 April 2026CanAlt Health Labs serves as the certified laboratory processing partner for the inFoods IBS commercial launch in Canada.
• Major Vietnamese healthcare distributorcoreChannel Partner/ Reseller/ Distributor · 18 February 2026Major Vietnamese healthcare distributor partnering with Biomerica to roll out the FDA-cleared EZ Detect at-home colorectal screening test through pharmacies, hospitals, physician offices, and online channels in Vietnam following Hanoi Department of Health approval.
• Henry Schein (Biotherapeutics Quarterly publication)minorGTM or Marketing Partner · 25 November 2025inFoods IBS diagnostic-guided therapy product was featured in Biotherapeutics Quarterly, a Henry Schein publication, highlighting a new precision approach for treating IBS based on a 223-patient multicenter clinical trial.
• Henry ScheinflagshipGTM or Marketing Partner · 16 October 2025Henry Schein and Biomerica entered into a marketing services agreement for the inFoods IBS test in the U.S. (excluding New York State). Henry Schein's extensive distribution network supports adoption among primary care and gastroenterology practices, leveraging recent clinical study results demonstrating the test's efficacy.
• Ethos LaboratoriesflagshipChannel Partner/ Reseller/ DistributorEthos Laboratories is Biomerica's CLIA-certified, CAP-accredited high-complexity laboratory partner that processes inFoods IBS samples. The Medicare Administrative Contractor confirmed to Ethos Laboratories that inFoods IBS claims will be reviewed on an individual, claim-by-claim basis under Medicare's standard approval process.
• University of MichigancoreStrategic or Co-development PartnerUniversity of Michigan investigators co-authored the real-world clinical effectiveness study of inFoods IBS diagnostic-guided therapy accepted for poster presentation at DDW 2026. Dr. William Chey, MD, AGAF, FACG, FACP, serves as a Principal Investigator on the inFoods IBS clinical study and as a member of the Scientific Advisory Board.
• Cleveland CliniccoreStrategic or Co-development PartnerCleveland Clinic investigators co-authored the real-world clinical effectiveness study of inFoods IBS diagnostic-guided therapy accepted for DDW 2026 poster presentation.

Scale indicators16 records

Recent moves9 records

Expansion highlights6 records

Direct peers

• Meridian Bioscience (now part of Revvity): Meridian Bioscience developed and sold H. pylori stool antigen tests and a broad IVD menu that overlapped directly with Biomerica's HP Detect Stool Antigen ELISA, EZ-H. pylori, and GAP IgA/IgG/IM ELISA lines. Now under Revvity, it remains the closest comparable in clinical gastroenterology diagnostics for Biomerica's product set.
• Exact Sciences: Exact Sciences' Cologuard competes with Biomerica's EZ Detect colorectal screening test in the at-home fecal occult blood / colorectal disease category. Both companies target similar patient and physician channels with stool-based, FDA-cleared colorectal screening products.
• OraSure Technologies: OraSure specializes in at-home and point-of-care diagnostic sample collection and testing (e.g., HIV, OTC), making it a direct comparable for Biomerica's at-home EZ Detect and Fortel product family sold through OTC retail pharmacy and online channels.
• Everlywell: Everlywell sells direct-to-consumer at-home diagnostic test kits across food sensitivity, gut health, hormones, and chronic disease — overlapping with Biomerica's at-home Fortel (hCG, ovulation, PSA, kidney, H. pylori) and food-intolerance Allerquant panels on channel and product.
• LetsGetChecked: LetsGetChecked offers at-home diagnostic test kits with online ordering and lab processing for digestive, hormonal, and chronic conditions, mirroring Biomerica's OTC/online EZ Detect and Fortel at-home diagnostic strategy, including consumer-facing e-commerce storefronts.

Broad incumbents

• QuidelOrtho: QuidelOrtho is a large, diversified IVD and rapid diagnostic testing company whose lateral flow and immunoassay portfolio spans rapid infectious disease, women's health, and gastrointestinal testing — the same core ELISA/lateral flow capabilities Biomerica uses across its Fortel, EZ Detect, and Allerquant lines.
• Bio-Rad Laboratories: Bio-Rad is a global clinical diagnostics and life science research company with ELISA kit development, IVD manufacturing, and CDMO services that mirror Biomerica's Allerquant food-intolerance panels, Isletest autoimmune ELISA, and contract development capabilities at much larger scale.
• Hologic: Hologic is a large molecular and clinical diagnostics company whose women's health, infectious disease, and gastrointestinal assay portfolio (including stool-based tests) overlaps thematically with Biomerica's women's health, gastrointestinal, and clinical lab ELISA product lines.
• Catalent (CDMO): Catalent is a major contract development and manufacturing organization serving biologics, cell/gene therapy, and diagnostics customers. Its diagnostic CDMO offering competes with Biomerica's expanded CDMO services for assay development, antibody services, and manufacturing at FDA-registered cGMP facilities.
• Abbott Diagnostics: Abbott offers H. pylori stool antigen and serology assays, gastrointestinal diagnostics, and at-home testing products that directly compete with Biomerica's HP Detect, hp+detect, EZ-H. pylori, and broader GI menu through much larger distribution and global scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks1 record

Key highlights1 record

Customer concentration

• Xx.com/biomerica_inc
• YouTubeyoutu.be/1zidsi42tuA
• Facebookfacebook.com/Biomerica-Inc-1446686552219764
• LinkedInlinkedin.com/company/biomerica
• Instagraminstagram.com/biomerica_inc

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds3 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Biomerica