Biomerica's inFoods IBS Test Shows 59% Response Rate in Real-World Study, Secures $300 Medicare Payment
核心洞察
Biomerica's real-world study of 69 IBS (搜索) patients demonstrated that 59.4% achieved clinically meaningful abdominal pain (搜索) reduction and 68.1% experienced significant bloating (搜索) relief using FDA-recognized responder endpoints.
The Centers for Medicare & Medicaid Services (搜索) established a $300 national Medicare payment rate for the inFoods IBS (搜索) test, effective January 1, 2026, providing reimbursement clarity for the diagnostic.
Real-world results closely mirror the company's peer-reviewed randomized controlled trial published in Gastroenterology, which showed 59.6% pain response rates across five major academic centers.
Biomerica announced compelling real-world evidence for its inFoods IBS (搜索) diagnostic test, with nearly 60% of patients achieving clinically meaningful pain reduction in an ongoing study. The data, combined with a newly established $300 Medicare payment rate, positions the personalized diagnostic as a significant advancement in irritable bowel syndrome (搜索) management.
Real-World Clinical Performance Validates Controlled Trial Results
The responder analysis examined 69 patients who completed the full 8-week study protocol with both baseline and endpoint assessments. Using the FDA-recognized responder definition of ≥30% improvement in weekly average symptom scores—the same endpoint applied to IBS (搜索) drug therapies—the results demonstrated substantial clinical benefit:
- Abdominal Pain: 59.4% of patients (41 of 69) met the responder threshold
- Bloating: 68.1% of patients (47 of 69) achieved clinically meaningful improvement
Among the 62 patients who tested positive for one or more food sensitivities (搜索) on the IBS (搜索)-specific IgG (搜索) assay, mean abdominal pain (搜索) scores decreased 34.6%, from 3.24 at baseline to 2.12 at 8 weeks (P = 0.0002). Mean bloating (搜索) scores declined 41.7%, from 4.35 to 2.54 at 8 weeks (P < 0.0001).
The real-world findings closely mirror results from Biomerica's peer-reviewed randomized controlled trial published in Gastroenterology. That pivotal study, conducted across five major academic centers including Mayo Clinic, Cleveland Clinic, Beth Israel Deaconess Medical Center, University of Michigan, and Houston Methodist Hospital (搜索), demonstrated 59.6% pain response rates in the treatment arm versus 42.1% in the sham diet arm (p = 0.02).
"This responder analysis represents another significant data set for inFoods IBS (搜索)," said Zack Irani, CEO of Biomerica. "Nearly 60% of patients saw clinically meaningful pain relief and more than two-thirds experienced significant improvement in bloating (搜索)—using the FDA's own standard for clinical response."
Medicare Payment Rate Establishes Reimbursement Foundation
The Centers for Medicare & Medicaid Services (搜索) established a national Medicare payment rate of $300 for the inFoods IBS (搜索) test under the Clinical Laboratory Fee Schedule, effective January 1, 2026. This milestone follows the American Medical Association's approval of a unique CPT Proprietary Laboratory Analyses code for inFoods IBS, which became effective October 1, 2025.
CMS represents the single largest payer for healthcare in the United States, with Medicare responsible for approximately 21% of total healthcare expenditure. Adults of Medicare age comprise over 20% of US adults and represent a substantial portion of patients with IBS (搜索) symptoms, making Medicare coverage critical for test accessibility.
The company plans to work with Medicare Administrative Contractors to begin coverage and will use the CMS pricing as a benchmark for negotiations with private commercial insurers including Aetna, United Healthcare, and Blue Cross.
Addressing Significant Unmet Medical Need
Irritable bowel syndrome (搜索) affects an estimated 30 to 45 million adults in the United States, representing 10%-15% of the adult population. The condition leads to decreased quality of life, lost productivity, and reliance on medications with adverse side effects. Current IBS (搜索) drugs address symptoms without targeting the underlying dietary triggers specific to each patient.
The inFoods IBS (搜索) test takes a fundamentally different approach through precision diagnostics that identify individual food triggers via a simple finger-stick blood test, enabling targeted, patient-specific dietary recommendations. This non-pharmacologic, personalized solution addresses a significant unmet clinical need within an estimated $30 billion total addressable market.
The clinical benefits were particularly notable in difficult-to-treat patient populations. Among IBS-C (搜索) patients, 67.1% in the treatment group achieved FDA-target pain reduction versus 35.8% in the control group. Among IBS-M (搜索) patients, 66% of patients in the treatment group experienced meaningful pain relief compared to 29.5% in the control group.
Commercial Infrastructure Development
Biomerica has established key commercial partnerships to support market expansion. In late 2025, the company entered into a marketing services agreement with Henry Schein, Inc., providing access to more than 400 medical field sales and tele-sales representatives targeting primary care and gastroenterology practices nationwide.
"The convergence of Level 1 clinical evidence, a dedicated PLA code, and a national CLFS price represents an important inflection point for InFoods IBS (搜索)," said Scott Madel, Chief Commercial Officer of Biomerica.
The company has also made available a new interview with gastroenterologist Dr. Dak Patel discussing his clinical experience prescribing inFoods IBS (搜索), offering insight into real-world integration and patient outcomes.
These commercial milestones, combined with the consistent real-world clinical performance data, establish inFoods IBS (搜索) as the only targeted therapy to demonstrate efficacy specifically in IBS-M (搜索) patients, a subgroup historically underserved by existing treatments.