Press Releases May 28, 2026 08:19 AM

Biomerica Lands a $1.75 Million CDMO Master Services Agreement for IVD Diagnostic Development

Biomerica secures a $1.75 million multi-year CDMO contract to develop proprietary IVD assays, expanding revenue streams.

By Leila Farooq BMRA

Biomerica announced a Master Services Agreement worth $1.75 million with a confidential life sciences company to develop proprietary in vitro diagnostic assays over an initial three-year term. This contract leverages Biomerica's established ELISA-based assay development capabilities and infrastructure without diverting focus from its core inFoods® IBS product. The agreement is expected to generate near-term revenue with minimal additional costs, demonstrating effective monetization of the company’s scientific expertise and manufacturing facilities.

Biomerica Lands a $1.75 Million CDMO Master Services Agreement for IVD Diagnostic Development
BMRA

Key Points

  • Biomerica signed a multi-year CDMO Master Services Agreement with initial target fees over $1.75 million for IVD assay development.
  • The contract emphasizes Biomerica's ELISA assay expertise and uses FDA-licensed, ISO 13485-certified facilities in Irvine, CA.
  • This new revenue stream complements Biomerica's primary commercial focus on the inFoods® IBS diagnostic platform and provides operating leverage with minimal incremental costs.

IRVINE, Calif., May 28, 2026 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a developer and manufacturer of diagnostic test systems and CDMO services provider, today announced it has entered into a Master Services Agreement (MSA) with a confidential life sciences company to develop proprietary in vitro diagnostic (IVD) assays. The engagement carries an initial contract development target fee of over $1.75 million, to be earned across multiple Statements of Work (SOWs) under the MSA. Biomerica was chosen following a competitive evaluation in which multiple CDMO organizations were assessed.

The MSA establishes an initial three-year term with automatic one-year renewals. All development work will be performed at Biomerica’s FDA-licensed, ISO 13485-certified facility in Irvine, California. Revenue will be recognized on a milestone-completion basis as individual SOW deliverables are accepted.

CDMO STRATEGY AND REVENUE CONTEXT

This CDMO engagement is a direct expression of the same ELISA-based assay development expertise that underpins Biomerica’s own inFoods® IBS technology platform — using capabilities built and refined over more than 40 years. The Company is not pivoting from its core focus; rather, it is monetizing its established infrastructure and scientific capabilities in a capital-efficient, parallel revenue stream. inFoods® IBS remains Biomerica’s primary commercial priority.

The development work is designed to be completed by Biomerica’s existing team of research scientists using the Company’s existing equipment and infrastructure. This capital-light structure is expected to require minimal incremental costs, creating meaningful operating leverage as the CDMO program scales.

MANAGEMENT COMMENTARY

“Biomerica’s primary mission remains the commercialization of inFoods® IBS — a clinically validated, precision diagnostic that we believe has the potential to transform how IBS is managed for millions of patients. At the same time, the scientific infrastructure, regulatory expertise, and ELISA development capabilities we have built to bring inFoods to market are now generating direct revenue through our CDMO business.

The $1.75 million in initial development fees provides near-term revenue visibility and demonstrates that the capabilities Biomerica has built over more than 40 years — in assay development, regulatory compliance, and IVD manufacturing — have direct commercial value beyond our own product pipeline.”

— Zack Irani, Chief Executive Officer, Biomerica, Inc.

The identity of the partner organization is not being disclosed at this time pursuant to confidentiality obligations.

ABOUT BIOMERICA, INC.

Biomerica, Inc. (Nasdaq: BMRA) is a global biomedical technology company that develops, manufactures, and markets diagnostic test systems and provides integrated CDMO services for the healthcare market. The Company specializes in immunoassay-based technologies, including ELISA and lateral flow platforms, with more than 40 years of expertise in assay development, manufacturing, and regulatory compliance. Biomerica holds ISO 13485 certification, is registered with the U.S. Food and Drug Administration, and has supported regulatory submissions in multiple jurisdictions including FDA 510(k) clearances and EU IVDR registrations. The Company’s flagship inFoods® IBS product is a precision diagnostic-guided therapy validated in a landmark multicenter clinical trial published in Gastroenterology. For more information, visit www.biomerica.com and www.inFoodsIBS.com.


INVESTOR RELATIONS CONTACT


Biomerica, Inc. │ 17571 Von Karman Ave, Irvine, CA 92614
[email protected] │ (949) 645-2111 │ www.biomerica.com


Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the target contract development fee of approximately $1.75 million, expectations regarding SOW execution, milestone completion, and program timelines, and the Company’s expectations regarding its CDMO business as a revenue stream. The $1.75 million aggregate estimate is across multiple SOWs that have not all been executed; no revenue is recognized absent an executed SOW and accepted milestone deliverables. Actual results may differ materially due to SOW non-execution, program cancellation, MSA termination, and other risks described in the Company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Biomerica undertakes no obligation to update or revise any forward-looking statements, except as required by applicable law.

Source: Biomerica, Inc.


Risks

  • The $1.75 million revenue is contingent on execution of multiple Statements of Work and milestone acceptance, with potential non-execution risks.
  • The partner company remains confidential, introducing uncertainty about long-term collaboration and revenue visibility.
  • As a CDMO engagement reliant on existing infrastructure, scaling beyond current capacity or delays could impact profitability and program timelines.

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