PLA Code Application Filed for inFoods IBS Test — A Key Step Toward Reimbursement
- PLA code application submission represents progress toward insurance reimbursement coverage
- Clinical trial published in Gastroenterology showed significant symptom relief compared to placebo
- Large addressable market with IBS affecting 10-15% of U.S. adults
- Test already available through direct-to-consumer channel
- Insurance reimbursement not yet secured
- PLA code approval still pending
- Significant competition from existing IBS treatments and diagnostic methods
Insights
Biomerica's PLA code application is a critical milestone toward insurance coverage for inFoods IBS, potentially unlocking broader market access and revenue growth.
This PLA code application represents a pivotal regulatory milestone in Biomerica's commercialization strategy for inFoods IBS. In the diagnostic reimbursement landscape, a dedicated billing code is foundational for securing insurance coverage - without it, payers lack standardized mechanisms to process claims, severely limiting patient access.
The PLA code system provides novel tests with unique identifiers that enable transparent claims adjudication. For Biomerica, this application marks the transition from a primarily self-pay model toward potential insurance coverage that would dramatically expand accessibility. This is particularly significant for a condition like IBS that affects 10-15% of U.S. adults and contributes billions in annual healthcare costs.
What strengthens inFoods' reimbursement case is its published randomized clinical validation in Gastroenterology showing superior symptom improvement versus placebo diets. Payers increasingly require such evidence demonstrating improved outcomes before granting coverage.
While this submission is just one step in a multi-phase process toward actual reimbursement, it demonstrates management's commitment to navigating the complex regulatory landscape. The company is simultaneously pursuing multiple commercial channels - working with gastroenterology practices while building a direct-to-consumer pathway through their website, creating revenue opportunities during the reimbursement process.
- Application represents milestone toward broadening patient access to inFoods IBS
- inFoods® IBS pinpoints patient-specific foods that can trigger IBS symptoms like bloating, abdominal pain, diarrhea, and constipation
IRVINE, Calif. , May 07, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ: BMRA), a global biomedical company dedicated to the development of advanced diagnostic products, announced that the Company and its CLIA laboratory partner have submitted an application to the American Medical Association (AMA) CPT Editorial Panel requesting the assignment of a Proprietary Laboratory Analysis (PLA) code for the inFoods® IBS diagnostic test. If granted, the PLA code will provide a test-specific code to submit claims to Medicare and other insurers. The PLA code would represent a next step on the pathway to expand patient access to the inFoods IBS product, a personalized test and therapy for treating Irritable Bowel Syndrome (IBS).
Strategic Milestone to Expand Patient Access
The PLA code application supports Biomerica’s commercialization strategy to facilitate access to the inFoods® IBS test. The establishment of a PLA code for inFoods® IBS will allow for transparency in claims submission and adjudication for inFoods® IBS, and is a step towards enabling substantially more patients to benefit from the test.
“Submitting the PLA code application is indicative of our growth strategy,” said Zack Irani, CEO of Biomerica. “Insurance reimbursement is essential to accelerating physician adoption, expanding patient access, and ultimately unlocking the full commercial value of our inFoods® technology platform, and a test-specific code will enable insurers to adjudicate claims for inFoods® IBS.”
Addressing an Unmet Need in IBS Care
The inFoods® IBS test is a novel, non-invasive diagnostic that identifies patient-specific IBS trigger foods that may be contributing to IBS symptoms such as bloating, abdominal pain, diarrhea, and constipation. By measuring immune responses to common foods, the test enables healthcare providers to make targeted dietary recommendations that reduce IBS symptoms and improve quality of life. This differentiated approach positions inFoods® as a clinically actionable alternative to the current trial-and-error diets and symptom-suppressing medications.
IBS affects an estimated
Clinical Validation and Commercial Momentum
A published, randomized clinical trial in Gastroenterology—the leading medical journal in gastrointestinal science—demonstrated that patients who followed a personalized diet based on inFoods® test results experienced significantly greater symptom relief compared to those on a placebo diet. These results underscore the clinical potential of the platform to meaningfully improve quality of life for IBS patients.
Biomerica is actively working with leading gastroenterology groups and healthcare systems to drive adoption of inFoods® IBS. Additionally, the test is now available for direct-to-consumer ordering via www.inFoodsIBS.com, expanding access to the growing self-pay and wellness markets.
Positioned for Long-Term Value Creation
The Company believes that insurance reimbursement, supported by growing clinical validation, positions inFoods® IBS as a category-defining diagnostic. This application marks one of several steps Biomerica is taking to advance its vision of delivering personalized, non-pharmaceutical diagnostics and therapies that address widespread, high-cost health conditions.
Biomerica’s inFoods® platform has the potential to transform how IBS—and potentially other GI-related disorders—are diagnosed and managed, creating value for patients, providers, and shareholders.
About Biomerica (NASDAQ: BMRA)
Biomerica, Inc. (www.biomerica.com or www.inFoodsIBS.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. For more information, visit www.inFoodsIBS.com and www.biomerica.com.
About inFoods®
The inFoods IBS test is designed to assess a patient’s above normal immunoreactivity to specific foods utilizing a simple finger-stick blood sample. Instead of difficult to manage broad dietary restrictions, physicians can now use the inFoods IBS information to make targeted, patient-specific recommendations about trigger foods that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea and constipation. The inFoods IBS test and clinical outcomes were studied at several prominent centers including Mayo Clinic, Beth Israel Deaconess Medical Center Inc. - a Harvard Medical School Teaching Hospital, Houston Methodist Hospital, and the University of Michigan. The clinical results for improvement in the Abdominal Pain Intensity (API) responder endpoint of >
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 (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 applying for a PLA code for the inFoods IBS product, and the future possibility of inFoods IBS receiving insurance reimbursement from Medicare or other insurers, the Company’s current and future sales, revenues, overhead, expenses, cost of goods, operations and earnings, efficacy of the Company’s products and tests, FDA and/or international regulatory authorization for the Company’s products to be marketed and sold, including the inFoods IBS product, and the Company’s other current and future products, the possible expansion in to other markets, uniqueness of the Company’s products, accuracy of the Company’s tests and products, expected completion of clinical studies, pricing of the Company’s test kits, domestic and/or international market adoption and acceptance and demand for the Company’s products, 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 inFoods 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
949-645-2111
investors@biomerica.com
Source: Biomerica, Inc.
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