InFoods IBS receives CPT® Proprietary Laboratory Analysis (PLA) Code
- PLA Code issuance by the American Medical Association CPT editorial panel marks a meaningful step toward attaining health insurance reimbursement and expanded patient access for inFoods® IBS
- inFoods® IBS provides personalized identification of food triggers to substantially improve IBS-related symptoms like bloating, abdominal pain, diarrhea, and constipation
IRVINE, Calif., July 02, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ:BMRA), a global biomedical company focused on innovative gastroenterology diagnostics, today announced that the American Medical Association CPT editorial panel has issued a Current Procedural Terminology (CPT®) code in the Proprietary Laboratory Analysis (PLA) code category for the Company's inFoods® IBS test.
This newly granted PLA code assigns a unique identifier to the test, allowing for the submission of claims to Medicare and private insurers for the Company's inFoods IBS test once the code becomes effective on October 1, 2025. The PLA code represents a next step on the pathway to expand patient access to the inFoods® IBS test.
Milestone to Expand Patient Access
The issuance of a PLA code represents a milestone in Biomerica's commercialization strategy and its efforts to expand access to inFoods® IBS. A test specific billing code allows for transparency in claims submission and adjudication for inFoods® IBS.
"This is an important step toward enabling more patients to access our inFoods® IBS test through health insurance reimbursement," said Zack Irani, CEO of Biomerica. "The PLA code not only streamlines the claims process but also supports our broader goal of helping more patients and physicians adopt a personalized, non-drug approach to managing IBS symptoms by adoption of our inFoods® technology."
"Securing a PLA code for our inFoods® IBS test is a milestone that strengthens our commercial strategy," said Scott Madel, Chief Commercial Officer of Biomerica. "It positions us to accelerate insurance reimbursement efforts and opens the door to reaching millions of patients who are actively seeking better, more personalized solutions for their IBS symptoms."
A Clinically Actionable Solution for IBS Patients
The inFoods® IBS test is a first-of-its-kind diagnostic that identifies patient-specific foods that may be triggering IBS symptoms. By measuring immune responses above the normal level to a clinically defined panel of common foods, the test helps healthcare providers deliver personalized dietary therapy guidance—offering a targeted alternative to trial-and-error diets and symptom-masking medications.
IBS affects an estimated 10% to 15% of adults in the U.S. and is associated with up to $10 billion in direct annual medical costs. inFoods® IBS addresses this substantial unmet need by offering a scientifically validated, non-invasive tool to improve symptom control and enhance quality of life for patients.
Clinical Trial Data and Commercial Momentum
Results from a randomized, controlled clinical trial published in the June 2025 issue of Gastroenterology, the leading journal in the field, showed that patients who followed a diet based on inFoods® test results experienced significantly greater symptom reduction than those on a placebo diet. These data provide strong clinical validation of the test's effectiveness and value.
The inFoods® IBS test is currently available through leading gastroenterology practices and is also offered directly to consumers via www.inFoodsIBS.com, enabling broader access through both traditional and self-pay channels.
Positioned for Long-Term Value Creation
The issuance of the PLA code for inFoods® IBS improves transparency in the reimbursement of this innovative test, supporting the Company's mission to deliver personalized, non-drug solutions for chronic conditions. As insurance coverage is enabled and clinical evidence grows, inFoods® IBS is poised to become an important tool in the treatment and management of IBS and related gastrointestinal disorders.
Biomerica's inFoods® platform continues to represent a scalable opportunity for innovation in GI care—driving better outcomes for patients and delivering value for healthcare providers and shareholders alike.
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®
inFoods® IBS is a diagnostic-guided therapy that identifies patient-specific food triggers responsible for symptoms such as abdominal pain, bloating, diarrhea, and constipation. Using a simple finger-stick blood sample, the test enables physicians to recommend targeted dietary changes tailored to the patient's immune response—offering a non-pharmaceutical, precision-based approach to symptom relief.
A multicenter, double-blind clinical study on the inFoods® IBS test was published in the June 2025 issue of Gastroenterology, the top peer-reviewed GI journal. As the largest study of its kind, it demonstrated statistically significant outcomes:
- 59.6% of patients in the treatment group (who eliminated identified trigger foods) achieved the FDA's endpoint for abdominal pain reduction, compared to 42.2% in the control group.
- Among IBS-C patients, 67.1% of patients in the treatment group vs. 35.8% in the control group.
- Among IBS-M patients, 66% of patients in the treatment group vs. 29.5% in the control group.
These results highlight inFoods® IBS as the only targeted therapy to demonstrate efficacy specifically in IBS-M patients, a subgroup historically underserved by existing treatments. The study was conducted at leading U.S. institutions including Cleveland Clinic, Mayo Clinic, University of Michigan, and Beth Israel Deaconess Medical Center.
For more information about inFoods® IBS, visit www.inFoodsIBS.com.
inFoods® IBS is a Laboratory Developed Test (LDT) used within a single laboratory that is certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.
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 importance of the inFoods test in IBS, 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 oversight, 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
[email protected]
Source: Biomerica, Inc.
