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Biomerica Expands Contract Development and Manufacturing Services to Meet Growing Market Demand

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Biomerica (Nasdaq: BMRA) announced an expansion of its Contract Development and Manufacturing Organization (CDMO) services on Nov 6, 2025 to meet rising demand from diagnostic and biotechnology companies.

The company highlighted end-to-end capabilities across LFA, point-of-care, ELISA, multiplex ELISA, antibody/reagent services, recombinant antibody development, manufacturing/assembly, and global supply chain & technology transfer. Biomerica cited ISO 13485, CE-mark expertise, and an FDA-registered cGMP facility and said CDMO work is a growing contributor to revenue.

Biomerica (Nasdaq: BMRA) ha annunciato il 6 novembre 2025 un ampliamento dei servizi di Contract Development and Manufacturing Organization (CDMO) per soddisfare la domanda in crescita da parte di aziende diagnostiche e biotecnologiche.

L'azienda ha evidenziato capacità end-to-end tra LFA, point-of-care, ELISA, multiplex ELISA, servizi per anticorpi/reagenti, sviluppo di anticorpi ricombinanti, produzione/assemblaggio e catena di fornitura globale e trasferimento tecnologico. Biomerica ha citato ISO 13485, esperienza CE-mark e una struttura cGMP registrata FDA, e ha dichiarato che il lavoro CDMO contribuisce sempre di più al fatturato.

Biomerica (Nasdaq: BMRA) anunció una expansión de sus servicios CDMO el 6 de noviembre de 2025 para satisfacer la creciente demanda de empresas de diagnóstico y biotecnología.

La empresa destacó capacidades end-to-end entre LFA, point-of-care, ELISA, multiplex ELISA, servicios de anticuerpos/reagentes, desarrollo de anticuerpos recombinantes, fabricación/ensamblaje y cadena de suministro global y transferencia de tecnología. Biomerica citó ISO 13485, experiencia con CE-mark y una instalación cGMP registrada por la FDA y dijo que el trabajo CDMO es una fuente creciente de ingresos.

Biomerica (Nasdaq: BMRA) 는 진단 및 생명공학 회사의 증가하는 수요를 충족하기 위해 2025년 11월 6일 CDMO(Contract Development and Manufacturing Organization) 서비스 확장을 발표했습니다.

회사는 LFA, 포인트-오브-케어, ELISA, 멀티플렉스 ELISA를 포함한 엔드투엔드 역량, 항체/시약 서비스, 재조합 항체 개발, 제조/조립, 글로벌 공급망 및 기술 이전을 강조했습니다. Biomerica는 ISO 13485, CE-마크 전문성, FDA 등록 cGMP 시설을 언급했으며 CDMO 작업이 매출에 점점 더 기여하고 있다고 말했습니다.

Biomerica (Nasdaq : BMRA) a annoncé le 6 novembre 2025 l'expansion de ses services CDMO (Contract Development and Manufacturing Organization) pour répondre à la demande croissante des entreprises de diagnostic et de biotechnologie.

L'entreprise a mis en avant des capacités de bout en bout couvrant LFA, point-of-care, ELISA, ELISA multiplex, des services d'anticorps/reagents, le développement d'anticorps recombinants, la fabrication/assemblage et la chaîne d'approvisionnement mondiale ainsi que le transfert de technologies. Biomerica a cité ISO 13485, une expertise en CE-mark et une installation cGMP enregistrée par la FDA, et a déclaré que les activités CDMO contribuent de plus en plus au chiffre d'affaires.

Biomerica (Nasdaq: BMRA) kündigte am 6. November 2025 eine Erweiterung seiner CDMO-Dienstleistungen (Contract Development and Manufacturing Organization) an, um der wachsenden Nachfrage von Diagnostik- und Biotechnologieunternehmen gerecht zu werden.

Das Unternehmen hob End-to-End-Fähigkeiten in LFA, Point-of-Care, ELISA, Multiplex-ELISA hervor sowie Antikörper-/Reagenzien-Services, Entwicklung rekombinanter Antikörper, Herstellung/Montage und globale Lieferkette sowie Technologietransfer. Biomerica nannte ISO 13485, CE-Kennzeichnungsexpertise und eine FDA-registrierte cGMP-Anlage und erklärte, dass CDMO-Arbeiten einen wachsenden Beitrag zum Umsatz leisten.

Biomerica (Nasdaq: BMRA) أعلنت عن توسيع خدماتها في CDMO (منظمة التطوير والتصنيع التعاقدي) في 6 نوفمبر 2025 لتلبية الطلب المتزايد من شركات التشخيص والتكنولوجيا الحيوية.

أبرَزت الشركة قدرات شاملة عبر LFA، اختبارات نقطة الرعاية، ELISA، ELISA المتعدد، خدمات الأجسام/المواد، تطوير الأجسام المناعية المُعاد تركيبها، التصنيع/التجميع، وسلسلة التوريد العالمية ونقل التكنولوجيا. وأكدت Biomerica خبرة ISO 13485، وخبرة علامة CE، ومرفق cGMP مسجل لدى FDA، وذكرت أن أعمال CDMO تسهم بشكل متزايد في الإيرادات.

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Insights

Biomerica expands CDMO services, positioning its ISO‑certified, FDA‑registered manufacturing to capture rising third‑party diagnostic demand.

Biomerica formalized and expanded its Contract Development and Manufacturing Organization (CDMO) offering to serve diagnostic and biotechnology innovators, saying CDMO work is a growing contributor to revenue and that interest from large and smaller organizations has meaningfully increased as of Nov 06, 2025. The company highlights end‑to‑end capabilities across assay development, antibody and reagent services, recombinant antibody development, manufacturing and assembly, and supply‑chain and technology transfer support.

The announcement anchors competitiveness on explicit regulatory and quality credentials: ISO 13485, CE‑mark expertise, and an FDA registered cGMP facility. These certifications directly address regulatory compliance needs cited as reasons partners engage CDMOs and therefore materially support the stated revenue opportunity.

Key dependencies disclosed are partner demand and the company’s ability to convert inquiries into contracted projects; the update to the corporate website is a clear commercialization step to increase visibility. Monitor reported changes to CDMO revenue contribution, announcements of client engagements or contracts, and any future disclosures on manufacturing capacity or service uptake to gauge whether the expansion translates into sustained growth.

  • Rising Demand from Third-Party Diagnostic and Biotechnology Companies Drives CDMO Service Expansion
  • Comprehensive CDMO services now featured on Biomerica’s updated website

IRVINE, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical diagnostic solutions, today announced the expansion of its Contract Development and Manufacturing Organization (CDMO) services to meet accelerating market demand. The Company is enhancing its capabilities to provide greater value and reliability of product development and manufacturing across the entire development lifecycle for diagnostic innovators worldwide.

With more than 40 years of expertise in assay development, manufacturing, and regulatory compliance, Biomerica is increasingly being approached by biotechnology and diagnostic companies seeking a proven partner to accelerate innovation and scale manufacturing. The Company’s CDMO services are a growing contributor to revenue and represent an opportunity for growth.

“Over the past several years, we have experienced a meaningful increase in interest from both large diagnostic organizations to smaller innovative organizations who are seeking to leverage our specialized development expertise, regulatory compliance track record, and manufacturing capabilities,” said Zack Irani, CEO of Biomerica. “We are now formalizing and expanding these CDMO services, providing clients with end-to-end support from concept through commercial manufacturing.”

Comprehensive Capabilities

Biomerica’s CDMO services enable partners to reduce timelines, streamline production, and ensures reliable, high-quality outcomes in lateral flow, point-of-care diagnostics, ELISA tests, and Multiplex ELISA assays. The services span the entire development lifecycle, including:

  • Assay Development & Custom Solutions – Custom Lateral Flow Assay (LFA), ELISA and Multiplex ELISA development, companion diagnostics, and 96-well plate coating.
  • Antibody & Reagent Services – HRP antibody conjugation, biotinylation, and colloidal gold antibody conjugation.
  • Recombinant Antibody Development – development of high-quality recombinant antibodies and stable cell lines within weeks.
  • Manufacturing & Assembly – Lateral flow cassette assembly, automated ELISA plate coating, custom lyophilization, and automated reagent filling, labeling, and capping.
  • Supply Chain & Technology Transfer – Global sourcing and qualification of critical raw materials, full technology transfer support, and seamless scale-up into commercial production.

Expanded Website Visibility to Highlight CDMO Services

As part of this initiative, Biomerica has updated its corporate website to prominently feature its CDMO capabilities, making it easier for new partners to understand the Company’s expanded service offering. The updated site showcases service descriptions, and resources to further support collaboration with innovators (https://biomerica.com/contract-development-manufacturing/ )

Positioned for Growth

Backed by ISO 13485 certification, CE-mark expertise, and an FDA registered cGMP manufacturing facility, ensuring regulatory compliance and quality standards at every stage, Biomerica is well-positioned to capture the growing demand for outsourced diagnostic development and production. By providing integrated solutions, Biomerica enables partners to reduce development timelines, de-risk regulatory hurdles, and scale products more efficiently.

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. Biomerica’s expanding CDMO services provide pharmaceutical, biotechnology, and diagnostic companies with trusted solutions for assay development and scalable manufacturing.

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 contract product development, compliance and manufacturing, FDA and or international regulatory clearance and compliance for third parties, FDA clearance or possible future clearance of the Company’s own diagnostic tests and/or third-party diagnostic tests and other products, timing of the research, development manufacturing and commercial launch of any of the company’s tests and products or the tests and products of third parties, possible future revenues from contract research, development and manufacturing (CDMO) of tests and products for third-parties, growth in future revenues from the CDMO services provided to third-parties, sale of the company’s own tests and products, international regulatory approval and sales of the company’s tests and products and the products developed by the company for third-parties, the rapidity of research and development of products for third-parties, the company’s ability to manufacture their own tests and products as well as the tests and products of third-parties, and the ability to increase manufacturing capacity to meet future product demands, and competitiveness of the company’s CDMO services pricing. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: results of research, development and manufacturing of third-party tests; regulatory approvals necessary prior to commercialization of any of the products and tests development and manufactured for third-parties; capacity, resource and other constraints on our suppliers; dependence on our own third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for our tests and other products developed and/or manufactured by the company; competition from other similar products and services from competitors that have significantly more financial and other resources available to them; the Company’s ability to comply with current and future regulations in the countries where our products are made and sold; and the Company’s ability to obtain patent protection on any aspects of its rapid test 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
949-645-2111
investors@biomerica.com

Source: Biomerica, Inc.


FAQ

What CDMO services did Biomerica (BMRA) expand on Nov 6, 2025?

Biomerica expanded end-to-end CDMO services including LFA, point-of-care, ELISA, multiplex ELISA, antibody/reagent services, recombinant antibody development, manufacturing, and supply chain/technology transfer.

How does Biomerica (BMRA) describe its regulatory qualifications for CDMO work?

Biomerica said it is backed by ISO 13485, has CE-mark expertise, and operates an FDA-registered cGMP manufacturing facility.

What manufacturing capabilities did Biomerica (BMRA) list in the Nov 6, 2025 announcement?

Capabilities include lateral flow cassette assembly, automated ELISA plate coating, custom lyophilization, automated reagent filling, labeling, and capping.

Will Biomerica (BMRA) support technology transfer and commercial scale-up?

Yes. The announcement states Biomerica provides full technology transfer support, global sourcing of critical raw materials, and seamless scale-up into commercial production.

Does Biomerica (BMRA) offer recombinant antibody development and how fast?

The company said it offers recombinant antibody development and stable cell line development within weeks.

How will Biomerica (BMRA) promote its expanded CDMO services to partners?

Biomerica updated its corporate website to prominently feature CDMO capabilities and service descriptions to make partner engagement easier.
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