InFoods IBS receives CPT庐 Proprietary Laboratory Analysis (PLA) Code
Biomerica (NASDAQ: BMRA) has achieved a significant milestone as its inFoods庐 IBS test received a CPT庐 Proprietary Laboratory Analysis (PLA) code from the American Medical Association CPT editorial panel. The code, effective October 1, 2025, enables insurance claims submission to Medicare and private insurers.
The inFoods庐 IBS test is a pioneering diagnostic tool that identifies patient-specific food triggers for IBS symptoms. Clinical trial results published in Gastroenterology demonstrated significant symptom reduction in patients following test-based dietary recommendations. The test addresses a substantial market, as IBS affects 10-15% of U.S. adults with $10 billion in direct annual medical costs.
Biomerica (NASDAQ: BMRA) ha raggiunto un traguardo importante con il suo test inFoods庐 IBS, che ha ottenuto un codice CPT庐 Proprietary Laboratory Analysis (PLA) dall'American Medical Association CPT editorial panel. Il codice, valido dal 1掳 ottobre 2025, consente la presentazione di richieste di rimborso assicurativo a Medicare e compagnie private.
Il test inFoods庐 IBS 猫 uno strumento diagnostico innovativo che identifica i trigger alimentari specifici per ciascun paziente con sindrome dell'intestino irritabile (IBS). I risultati degli studi clinici pubblicati su Gastroenterology hanno dimostrato una significativa riduzione dei sintomi nei pazienti che hanno seguito le raccomandazioni dietetiche basate sul test. Questo test risponde a un mercato rilevante, poich茅 l'IBS colpisce il 10-15% degli adulti negli Stati Uniti con costi medici diretti annui di 10 miliardi di dollari.
Biomerica (NASDAQ: BMRA) ha alcanzado un hito significativo con su prueba inFoods庐 IBS, que recibi贸 un c贸digo CPT庐 Proprietary Laboratory Analysis (PLA) del panel editorial CPT de la American Medical Association. El c贸digo, vigente a partir del 1 de octubre de 2025, permite la presentaci贸n de reclamaciones de seguro a Medicare y aseguradoras privadas.
La prueba inFoods庐 IBS es una herramienta diagn贸stica pionera que identifica los desencadenantes alimentarios espec铆ficos para cada paciente con s铆ndrome del intestino irritable (IBS). Los resultados de ensayos cl铆nicos publicados en Gastroenterology demostraron una reducci贸n significativa de los s铆ntomas en pacientes que siguieron recomendaciones diet茅ticas basadas en la prueba. La prueba aborda un mercado considerable, ya que el IBS afecta al 10-15% de los adultos en EE.UU. con costos m茅dicos directos anuales de 10 mil millones de d贸lares.
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inFoods庐 IBS 瓴�靷鐢 瓿茧靹彪寑鞛レ頉勱蛋(IBS) 頇橃瀽氤� 鞚岇嫕 鞙犽皽 鞖旍澑鞚� 鞁濍硠頃樀鐢 順侅嫚鞝侅澑 歆勲嫧 霃勱惮鞛呺媹雼�. Gastroenterology鞐� 氚滍憸霅� 鞛勳儊 鞁滍棙 瓴瓣臣鞐� 霐半ゴ氅�, 瓴�靷� 旮半皹 鞁濎澊 甓岅碃毳� 霐半ジ 頇橃瀽霌れ潣 歃濎儊鞚� 韥矊 臧愳唽頄堨姷雼堧嫟. 鞚� 瓴�靷鐢 氙戈淡 靹膘澑鞚� 10-15%臧� IBS毳� 鞎撽碃 鞛堨溂氅�, 鞐瓣皠 歆侅爲 鞚橂牍勱皜 100鞏� 雼煬鞐� 雼晿电� 韥� 鞁滌灔鞚� 雽�靸侅溂搿� 頃╇媹雼�.
Biomerica (NASDAQ: BMRA) a franchi une 茅tape importante avec son test inFoods庐 IBS, qui a re莽u un code CPT庐 Proprietary Laboratory Analysis (PLA) du comit茅 茅ditorial CPT de l'American Medical Association. Ce code, effectif 脿 partir du 1er octobre 2025, permet la soumission de demandes de remboursement aupr猫s de Medicare et des assureurs priv茅s.
Le test inFoods庐 IBS est un outil diagnostique innovant qui identifie les d茅clencheurs alimentaires sp茅cifiques 脿 chaque patient souffrant du syndrome de l鈥檌ntestin irritable (SII). Les r茅sultats des essais cliniques publi茅s dans Gastroenterology ont montr茅 une r茅duction significative des sympt么mes chez les patients suivant les recommandations di茅t茅tiques bas茅es sur le test. Ce test r茅pond 脿 un march茅 important, puisque le SII touche 10 脿 15 % des adultes am茅ricains, avec des co没ts m茅dicaux directs annuels de 10 milliards de dollars.
Biomerica (NASDAQ: BMRA) hat einen bedeutenden Meilenstein erreicht, da sein inFoods庐 IBS-Test vom CPT-Redaktionsausschuss der American Medical Association einen CPT庐 Proprietary Laboratory Analysis (PLA)-Code erhalten hat. Der Code, g眉ltig ab dem 1. Oktober 2025, erm枚glicht die Einreichung von Versicherungsanspr眉chen bei Medicare und privaten Versicherern.
Der inFoods庐 IBS-Test ist ein bahnbrechendes Diagnoseinstrument, das patientenspezifische Nahrungsmittelausl枚ser f眉r IBS-Symptome identifiziert. Klinische Studien, ver枚ffentlicht in Gastroenterology, zeigten eine signifikante Symptomreduktion bei Patienten, die di盲tetischen Empfehlungen basierend auf dem Test folgten. Der Test bedient einen bedeutenden Markt, da IBS 10-15% der erwachsenen US-Bev枚lkerung betrifft und direkte j盲hrliche medizinische Kosten von 10 Milliarden US-Dollar verursacht.
- Received PLA code enabling Medicare and private insurance claims submission
- Clinical trial results published in leading journal Gastroenterology showed significant symptom reduction
- Addresses large market with 10-15% of U.S. adults affected by IBS
- Test currently available through gastroenterology practices and direct-to-consumer channels
- Insurance reimbursement not yet secured - PLA code is just a first step
- Code doesn't become effective until October 1, 2025
Insights
Biomerica's inFoods IBS test secures crucial PLA code, advancing toward insurance coverage and wider market access.
The CPT PLA code granted by the AMA for Biomerica's inFoods IBS test represents a critical regulatory milestone in the diagnostic reimbursement pathway. This unique identifier, effective October 1, 2025, enables standardized billing submissions to both Medicare and private insurers鈥攅ssentially creating the "language" through which the healthcare system recognizes and processes claims for this specific test.
What makes this particularly significant is that PLA codes are typically only granted after a test demonstrates sufficient clinical utility and market relevance. For a diagnostic in the $10 billion IBS market affecting 10-15% of U.S. adults, this regulatory recognition substantially de-risks the commercial pathway.
The timing is strategically valuable as it coincides with recently published clinical validation in Gastroenterology, creating a powerful combination of regulatory recognition and scientific validation. While the PLA code itself doesn't guarantee coverage, it removes a major technical barrier in the reimbursement process and positions Biomerica to negotiate with payers from a much stronger position.
From a market access perspective, this creates a dual-pathway commercial strategy: the existing direct-to-consumer channel and the now-strengthened medical provider channel backed by potential insurance coverage. The PLA code specifically addresses one of the primary adoption barriers for novel diagnostics鈥攕implified billing pathways for clinicians鈥攚hich typically accelerates clinical uptake once coverage determinations follow.
Importantly, this positions the inFoods technology as a non-pharmaceutical intervention in a condition traditionally managed through symptom-focused medications, aligning with payer preferences for cost-effective approaches that address root causes rather than just managing symptoms.
- 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庐 IBS
- inFoods庐 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庐) code in the Proprietary Laboratory Analysis (PLA) code category for the Company鈥檚 inFoods庐 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鈥檚 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庐 IBS test.
Milestone to Expand Patient Access
The issuance of a PLA code represents a milestone in Biomerica鈥檚 commercialization strategy and its efforts to expand access to inFoods庐 IBS. A test specific billing code allows for transparency in claims submission and adjudication for inFoods庐 IBS.
鈥淭his is an important step toward enabling more patients to access our inFoods庐 IBS test through health insurance reimbursement,鈥� said Zack Irani, CEO of Biomerica. 鈥淭he 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庐 迟别肠丑苍辞濒辞驳测.鈥�
鈥淪ecuring a PLA code for our inFoods庐 IBS test is a milestone that strengthens our commercial strategy,鈥� said Scott Madel, Chief Commercial Officer of Biomerica. 鈥淚t 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.鈥�
A Clinically Actionable Solution for IBS Patients
The inFoods庐 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鈥攐ffering a targeted alternative to trial-and-error diets and symptom-masking medications.
IBS affects an estimated
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庐 test results experienced significantly greater symptom reduction than those on a placebo diet. These data provide strong clinical validation of the test鈥檚 effectiveness and value.
The inFoods庐 IBS test is currently available through leading gastroenterology practices and is also offered directly to consumers via , enabling broader access through both traditional and self-pay channels.
Positioned for Long-Term Value Creation
The issuance of the PLA code for inFoods庐 IBS improves transparency in the reimbursement of this innovative test, supporting the Company鈥檚 mission to deliver personalized, non-drug solutions for chronic conditions. As insurance coverage is enabled and clinical evidence grows, inFoods庐 IBS is poised to become an important tool in the treatment and management of IBS and related gastrointestinal disorders.
Biomerica鈥檚 inFoods庐 platform continues to represent a scalable opportunity for innovation in GI care鈥攄riving better outcomes for patients and delivering value for healthcare providers and shareholders alike.
About Biomerica (NASDAQ: )
Biomerica, Inc. ( or ) 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鈥� offices) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. The Company鈥檚 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 and .
About inFoods庐
inFoods庐 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鈥檚 immune response鈥攐ffering a non-pharmaceutical, precision-based approach to symptom relief.
A multicenter, double-blind clinical study on the inFoods庐 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鈥檚 endpoint for abdominal pain reduction, compared to42.2% 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庐 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庐 IBS, visit .
inFoods庐 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 鈥渟afe harbor鈥� 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庐 IBS product, and the future possibility of inFoods庐 IBS receiving insurance reimbursement from Medicare or other insurers, the importance of the inFoods test in IBS, the Company鈥檚 current and future sales, revenues, overhead, expenses, cost of goods, operations and earnings, efficacy of the Company鈥檚 products and tests, FDA and/or international regulatory authorization for the Company鈥檚 products to be marketed and sold, including the inFoods庐 IBS product, and the Company鈥檚 other current and future products, the possible expansion in to other markets, uniqueness of the Company鈥檚 products, accuracy of the Company鈥檚 tests and products, expected completion of clinical studies, pricing of the Company鈥檚 test kits, domestic and/or international market adoption and acceptance and demand for the Company鈥檚 products, future use of the Company鈥檚 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鈥檚 inFoods庐 tests and other products; regulatory approvals necessary prior to commercialization of the Company鈥檚 products; availability of the Company鈥檚 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鈥檚 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鈥檚 operating results due to its business model and expansion plans, downturns in international and or national economies, the Company鈥檚 ability to raise additional capital, the competitive environment in which the Company will be competing, and the Company鈥檚 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.
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