Clinical decision support for fibromyalgia diagnosis

Fibromyalgia affects up to 4% of adults, yet diagnosis remains largely exclusion-based and often delayed. Clinicians rely on symptom reporting and extensive negative testing to rule out inflammatory or autoimmune conditions.

The average time to diagnosis is ~5 years, driving repeated referrals, repeat investigations, and unnecessary cost. The absence of objective biomarkers limits early identification and makes it harder to triage patients into appropriate care pathways. There is a clear need for an accessible, objective tool that supports earlier, more confident identification in primary care and specialty settings.

SomaBiome is developing a non-invasive clinical decision support tool designed to integrate into existing diagnostic workflows. The process follows a structured three-step path: sample collection through participating clinical workflows, high-throughput sequencing at partner laboratories, and the generation of a specialized clinician report.

This tool is strictly defined as clinical decision support. It is intended to complement existing clinical assessments; the clinician remains the final decision-maker throughout the diagnostic journey.

SomaBiome is grounded in peer-reviewed microbiome research across fibromyalgia and chronic pain conditions. Selected publications include:

• Fibromyalgia (PAIN, 2019): species-level microbiome alterations associated with symptom severity and metabolomic shifts.
• Mechanistic validation (Gut, 2023): causal links between specific gut microbes, host inflammatory signaling, and clinical outcomes in a surgical model.
• Chronic pain generalization (Anesthesiology, 2025): reproducible microbiome signatures across independent cohorts and geographies.

Across published research cohorts, microbiome-based classifiers show ~90% case–control performance in retrospective research settings. SomaBiome is translating these findings into clinical decision support under development, designed for clinician interpretation and real-world validation.

SomaBiome is deploying a capital-efficient translation strategy centered on specialized pain clinics. By operating as a clinical decision support software layer atop existing sequencing infrastructure, SomaBiome can scale without laboratory ownership.

• Regulatory posture: Positioned as clinical decision support (CDS) under current Canadian frameworks, prioritizing clinician oversight to facilitate faster, safer pilot deployment.
• Operational model: We outsource wet-lab sequencing to accredited partners, keeping our core operations focused on computational analysis and reporting.
• Commercial pathway: Initial validation through controlled pilots in Québec and Israel, building the health economic evidence required for eventual reimbursement strategies.

SomaBiome is built for institutional and clinical integration. We focus on partnerships that accelerate the transition from research to real-world clinical utility:

• Clinicians and Specialty Centers: Partners interested in clinical pilots and evaluating objective decision support within pain management care pathways.
• Research Collaborators: Investigators seeking to integrate host–microbe models developed and evaluated in published research cohorts into translational studies.
• Translational Programs: Accelerators and institutional partners focused on de-risking the pathway from discovery to diagnostic development.
• Early Investors: Strategic partners looking for research-backed, capital-efficient ventures in the clinical decision support space.

Our operational model is dedicated to professional and research environments rather than direct-to-consumer distribution.

If you’re interested in collaborating or learning more, we’d love to connect.