Biomerica’s inFoods® IBS Clinical Trial Results Published and Featured in Gastroenterology, the Leading GI Medical Journal
Biomerica (NASDAQ: BMRA) has published clinical trial results for its inFoods® IBS test in Gastroenterology journal. The test identifies specific foods triggering elevated IgG antibody responses in IBS patients. A randomized, double-blind trial with 238 patients across eight U.S. academic centers showed significant results:
The treatment group following personalized elimination diets showed 59.6% success rate in pain reduction compared to 42.2% in the control group. Results were particularly strong for IBS-C patients (67.1% vs 35.8%) and IBS-M patients (66% vs 29.5%).
The test enables patients to eliminate only 2-4 trigger foods on average, offering a more targeted approach compared to traditional restrictive diets. This advancement is particularly significant for IBS-M patients, for whom no FDA-approved medications currently exist.
Biomerica (NASDAQ: BMRA) ha pubblicato i risultati di uno studio clinico per il suo test inFoods® IBS sulla rivista Gastroenterology. Il test identifica i cibi specifici che scatenano elevate risposte anticorpali IgG nei pazienti con IBS. Uno studio randomizzato, in doppio cieco, condotto su 238 pazienti in otto centri accademici statunitensi ha mostrato risultati significativi:
Il gruppo di trattamento che ha seguito diete personalizzate di eliminazione ha mostrato un tasso di successo del 59,6% nella riduzione del dolore rispetto al 42,2% del gruppo di controllo. I risultati sono stati particolarmente forti per i pazienti con IBS-C (67,1% contro 35,8%) e per i pazienti con IBS-M (66% contro 29,5%).
Il test consente ai pazienti di eliminare in media solo 2-4 cibi scatenanti, offrendo un approccio più mirato rispetto alle diete restrittive tradizionali. Questo progresso è particolarmente significativo per i pazienti con IBS-M, per i quali attualmente non esistono farmaci approvati dalla FDA.
Biomerica (NASDAQ: BMRA) ha publicado los resultados de un ensayo clínico para su prueba inFoods® IBS en la revista Gastroenterology. La prueba identifica alimentos específicos que provocan respuestas elevadas de anticuerpos IgG en pacientes con IBS. Un ensayo aleatorizado, doble ciego, con 238 pacientes en ocho centros académicos de EE. UU. mostró resultados significativos:
El grupo de tratamiento que siguió dietas de eliminación personalizadas mostró una tasa de éxito del 59,6% en la reducción del dolor en comparación con el 42,2% del grupo de control. Los resultados fueron particularmente sólidos para los pacientes con IBS-C (67,1% frente a 35,8%) y para los pacientes con IBS-M (66% frente a 29,5%).
La prueba permite a los pacientes eliminar en promedio solo de 2 a 4 alimentos desencadenantes, ofreciendo un enfoque más dirigido en comparación con las dietas restrictivas tradicionales. Este avance es particularmente significativo para los pacientes con IBS-M, para quienes actualmente no existen medicamentos aprobados por la FDA.
Biomerica (NASDAQ: BMRA)는 inFoods® IBS 테스트의 임상 시험 결과를 Gastroenterology 저널에 발표했습니다. 이 테스트는 IBS 환자에서 IgG 항체 반응을 유발하는 특정 음식을 식별합니다. 미국의 8개 학술 센터에서 238명의 환자를 대상으로 진행된 무작위 이중 맹검 시험에서 중요한 결과가 나타났습니다:
개인화된 제거 식단을 따르는 치료 그룹은 대조군의 42.2%에 비해 통증 감소에서 59.6%의 성공률을 보였습니다. IBS-C 환자(67.1% 대 35.8%)와 IBS-M 환자(66% 대 29.5%)에 대한 결과가 특히 강력했습니다.
이 테스트는 환자가 평균적으로 2-4개의 유발 음식을 제거할 수 있도록 하여 전통적인 제한식이 요법에 비해 보다 목표 지향적인 접근 방식을 제공합니다. 이 발전은 현재 FDA 승인 약물이 없는 IBS-M 환자에게 특히 중요합니다.
Biomerica (NASDAQ: BMRA) a publié les résultats d'un essai clinique pour son test inFoods® IBS dans la revue Gastroenterology. Le test identifie des aliments spécifiques déclenchant des réponses élevées d'anticorps IgG chez les patients atteints d'IBS. Un essai randomisé, en double aveugle, impliquant 238 patients dans huit centres académiques aux États-Unis a montré des résultats significatifs :
Le groupe de traitement suivant des régimes d'élimination personnalisés a montré un taux de succès de 59,6% dans la réduction de la douleur, contre 42,2% dans le groupe témoin. Les résultats étaient particulièrement forts pour les patients atteints d'IBS-C (67,1% contre 35,8%) et pour les patients atteints d'IBS-M (66% contre 29,5%).
Le test permet aux patients d'éliminer en moyenne seulement 2 à 4 aliments déclencheurs, offrant une approche plus ciblée par rapport aux régimes restrictifs traditionnels. Cette avancée est particulièrement significative pour les patients atteints d'IBS-M, pour lesquels il n'existe actuellement aucun médicament approuvé par la FDA.
Biomerica (NASDAQ: BMRA) hat die Ergebnisse einer klinischen Studie für seinen inFoods® IBS-Test in der Zeitschrift Gastroenterology veröffentlicht. Der Test identifiziert spezifische Lebensmittel, die erhöhte IgG-Antikörperreaktionen bei IBS-Patienten auslösen. Eine randomisierte, doppelblinde Studie mit 238 Patienten an acht akademischen Zentren in den USA zeigte signifikante Ergebnisse:
Die Behandlungsgruppe, die personalisierte Eliminationsdiäten befolgte, erzielte eine Erfolgsquote von 59,6% bei der Schmerzlinderung im Vergleich zu 42,2% in der Kontrollgruppe. Die Ergebnisse waren besonders stark bei IBS-C-Patienten (67,1% vs. 35,8%) und IBS-M-Patienten (66% vs. 29,5%).
Der Test ermöglicht es den Patienten, im Durchschnitt nur 2-4 auslösende Lebensmittel zu eliminieren, was einen gezielteren Ansatz im Vergleich zu traditionellen restriktiven Diäten bietet. Dieser Fortschritt ist besonders bedeutend für IBS-M-Patienten, für die derzeit keine von der FDA zugelassenen Medikamente existieren.
- Clinical trial results published in leading medical journal Gastroenterology
- 59.6% success rate in pain reduction for treatment group vs 42.2% control
- Strong efficacy in IBS-C (67.1%) and IBS-M (66%) patients
- Test requires elimination of only 2-4 foods on average
- Addresses unmet need for IBS-M patients with no current FDA-approved treatments
- Additional validation of the IgG antibody test still required
Insights
The publication of Biomerica's inFoods® IBS clinical trial results in Gastroenterology marks a pivotal moment for the company's commercial prospects. With 10-15% of U.S. adults affected by IBS, this represents a substantial market opportunity of approximately 33-49 million potential patients.
The study's results are particularly compelling from a commercial perspective. The test achieved 59.6% success rate in the treatment group, with even higher efficacy in IBS-C (67.1%) and IBS-M (66%) subtypes. These results are especially significant for IBS-M patients, where no FDA-approved medications currently exist, potentially positioning Biomerica to capture an underserved market segment.
Several key competitive advantages strengthen the commercial outlook:
- The test's unique 95% confidence interval cutoff for food panels, providing superior accuracy compared to existing IgG tests
- A targeted approach requiring elimination of only 2-4 foods on average, offering better patient compliance compared to restrictive FODMAP diets
- Strong validation through a multi-center, double-blind, placebo-controlled trial design
However, investors should consider several factors that could impact market adoption:
- The need for additional validation studies as mentioned by key opinion leaders
- Potential reimbursement challenges and pricing strategies
- The time required for healthcare provider education and adoption
The endorsement from leading gastroenterologists at prestigious institutions like Cleveland Clinic and University of Michigan adds significant credibility, potentially accelerating market acceptance. The precision nutrition approach aligns with growing healthcare trends toward personalized medicine, suggesting strong potential for long-term market penetration.
- inFoods IBS Provides Personalized Diet Therapy for Patients Suffering with Irritable Bowel Syndrome (IBS)
- Research Finds Patients Following a Personalized Diet Therapy Created with inFoods® IBS, Experienced Reduced Abdominal Pain and Bloating
IRVINE, Calif., Feb. 19, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global leader in advanced medical diagnostic solutions, is proud to announce that patients with Irritable Bowel Syndrome (IBS) may experience significant relief from abdominal pain when following a dietary therapy created and guided by the inFoods® IBS blood test. The findings from a clinical trial published in Gastroenterology, demonstrate that participants who adhered to a personalized diet therapy based on the test results experienced greater symptom improvement compared to those following a sham (placebo) elimination diet.
The inFoods® IBS test was designed specifically for IBS patients. It identifies individual foods that trigger an elevated (above normal) Immunoglobulin G (IgG) antibody responses—which is a marker of inflammation associated with IBS symptoms. Every food in the inFoods IBS panel is set with a
Irritable bowel syndrome (IBS) affects an estimated
“We have patients all the time who say, ‘I know food is a problem for me. Is there any way to figure out which foods I'm sensitive to?’” said Prashant Singh, MBBS, Michigan Medicine gastroenterologist and lead author on the paper.
Study Design and Key Findings
The randomized, multicenter, double-blind, placebo-controlled trial enrolled 238 IBS patients across eight leading academic centers in the U.S. Each participant was tested for IgG antibody responses to 18 common IBS trigger foods using the inFoods IBS® product. Patients were then randomly assigned to one of two groups:
- The treatment group eliminated actual foods identified by the inFoods test as triggering an abnormally high IgG antibody immune response in that patient.
- The control group (placebo) followed a sham diet that removed foods for which the patient tested negative with the inFoods IBS test and consumed in a similar amount, (e.g., if a patient tested positive for walnuts, they were instructed to eliminate almonds from their diet).
The study found that
“Patients had done all sorts of IgG antibody testing before, and it wasn’t very reliable. This latest test is supported by science. I can refer patients to this IBS-specific antibody testing, after explaining the science and the limitations of the study,” said Dr. Prashant Singh, MBBS.
A Personalized, Targeted Approach to IBS Management
While prior research suggested a potential link between IgG antibody responses and IBS symptoms, previous studies faced limitations such as small sample sizes, IgG tests not adequately designed for patients with IBS, single-center trials, and a lack of well-designed control diets. The inFoods® IBS study was specifically designed to overcome these shortcomings.
“One of the key challenges in past studies was distinguishing normal IgG responses from those that may contribute to IBS symptoms,” Singh explained. “This research takes a targeted approach by using an IBS-specific IgG test to personalize dietary recommendations.”
Compared to pharmaceuticals, personalized elimination diets offer a proactive approach to managing IBS by avoiding symptom triggers rather than treating inflammation after symptoms arise. Many existing IBS dietary interventions, such as the low-FODMAP diet, can be restrictive, difficult to follow, and costly. In contrast, the inFoods® IBS test enables patients to eliminate only a select number of trigger foods (2 to 4 foods on average) rather than broadly restricting their diet.
“Our diets are complex and identifying dietary triggers can be difficult. This IBS-specific IgG test can help patients who suffer from IBS identify specific dietary triggers,” said Anthony Lembo, M.D., vice chair of Research at Cleveland Clinic’s Digestive Disease Institute.
Advancing Toward Precision Therapy in IBS Treatment
The positive results observed in IBS-M patients are particularly significant, as no FDA-approved medications currently exist for treating this IBS subtype. The study underscores the potential for a precision nutrition approach, allowing healthcare providers to tailor dietary recommendations to each patient’s unique needs.
William Chey, M.D., chief of Gastroenterology & Hepatology at the University of Michigan and a principal investigator in the study, said: “This IBS-specific, IgG antibody test requires additional validation but could move us one step closer to a ‘precision nutrition’ approach, in which providers can offer personalized dietary recommendations to each patient with IBS.”
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.
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 inFoods® IBS test and other tests, FDA clearance or possible future clearance of the Company’s inFoods® IBS test and other products, timing of the commercial launch of the inFoods® IBS test, possible future revenues from the sale of the inFoods® IBS test, growth in future revenues from the sale of the inFoods® IBS test, acceptance of the inFoods® IBS test by physicians and their patients, international regulatory approval and sales of the inFoods® IBS test, accuracy, efficacy and clinical trial results of the inFoods® IBS test, the rapidity of testing results, discussions with physicians and physician groups who could or would offer the inFoods test to their patients, efficacy of the inFoods IBS test to improve IBS symptoms in patients, the company’s ability to manufacture the inFoods® IBS test as a commercial product and to increase manufacturing capacity to meet future product demands, the uniqueness of the Company’s inFoods® IBS test and other products, pricing of the Company’s inFoods® IBS test, future possible insurer reimbursement for the inFoods® IBS test, patent protection on the inFoods® IBS and the underlying technology of the test, or on any of the Company’s other products or technologies, and current or future competition for the inFoods® IBS test from other medical manufacturers or distributors. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: results of studies testing the efficacy of the Company’s tests and products; regulatory approvals necessary prior to commercialization of any of the Company’s products; availability of the Company’s test kits and other products; capacity, 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; 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
Source: Biomerica
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