Commonwealth Diagnostics International
Commonwealth Diagnostics International is a privately held US specialty diagnostics company that provides ISO 13485-certified hydrogen and methane breath testing for SIBO, IMO, and carbohydrate malabsorption disorders, serving gastroenterologists, primary care physicians, naturopathic doctors, and patients through its CLIA-certified laboratory and MyGI Gateway provider portal.
- Company typePrivate
- Founded2017
- HeadquartersSalem, United States
- Headcount101–250
- GTM typeB2B
- OfferingServices
What Commonwealth Diagnostics International does
Commonwealth Diagnostics International (CDI) is a privately held, US-based specialty diagnostics company founded in 2017 that focuses exclusively on functional gastrointestinal (GI) diagnostics through hydrogen and methane breath testing. The company's core product portfolio addresses Small Intestinal Bacterial Overgrowth (SIBO), Intestinal Methanogen Overgrowth (IMO), and carbohydrate malabsorption disorders (fructose, lactose, sucrose), with separate adult (10-tube) and pediatric (6-tube) test kits. Testing is conducted using proprietary gas chromatography (GC) instrumentation paired with a proprietary CO2 correction methodology, and supported by the MyGI Gateway HIPAA-compliant provider portal for ordering, tracking, and result delivery. CDI operates a CLIA-certified laboratory and holds ISO 13485, FDA registration, and CE Mark certifications, with its testing approach endorsed by the North American Consensus and ACG Clinical Guidelines.
CDI operates a hybrid go-to-market that combines a sales-led provider channel with a direct-to-patient motion. Healthcare providers (gastroenterologists, primary care physicians, naturopathic doctors) order kits at no cost through the MyGI Gateway portal or online order forms; CDI bills Medicare, Tricare, and a growing roster of commercial payers (Blue Cross Blue Shield of Massachusetts, CareFirst, Premera, Medica, Regence) on behalf of patients, with a registered cost of $699 per test and a maximum patient out-of-pocket of $299 (CPT Code 91065 x 2 units). Patients can also order tests directly for at-home administration with prepaid return shipping to CDI's laboratory. Strategic partnerships with the American College of Gastroenterology, Rome Foundation, Rupa Health, My Total Health, CliniOps, the University of Michigan, and SAM.gov (VA Community Care Network) extend CDI's distribution into conventional gastroenterology, integrative medicine, clinical research, and government healthcare channels across the US and Canada.
Commonwealth Diagnostics International firmographics
Firmographics- Name
- Commonwealth Diagnostics International
- Legal name
- Commonwealth Diagnostics International
- Website
- https://commdx.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Commonwealth Diagnostics International is a privately held US specialty diagnostics company that provides ISO 13485-certified hydrogen and methane breath testing for SIBO, IMO, and carbohydrate malabsorption disorders, serving gastroenterologists, primary care physicians, naturopathic doctors, and patients through its CLIA-certified laboratory and MyGI Gateway provider portal.
- Ownership category
- akta.pro rank
Commonwealth Diagnostics International industry classification
Industry- Product category
- Functional GI Diagnostics
- NAICS
- Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)
- SIC
- Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)
- akta.pro primary industry
- Companion Diagnostics (CDx) & Precision Medicine IVD (HLAHAAAJ)
- akta.pro secondary industry
- General Gastroenterology (HLAKAEAA)
Keywords
Where Commonwealth Diagnostics International is headquartered
LocationHeadquarters
- HQ city
- Salem
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Commonwealth Diagnostics International business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Supply Chain, Marketing or Sales, Others
Revenue model
- Diagnostic Testing Services: CDI generates revenue through providing hydrogen and methane breath test kits and laboratory analysis services. Healthcare providers order kits at no cost, and CDI bills insurance (Medicare, commercial insurance, Tricare) on behalf of patients after tests are completed and returned for analysis. Registered cost is $699 per test with maximum patient out-of-pocket of $299.
- Direct Patient Payment: Patients without insurance coverage or those on Medicaid (CDI does not accept Medicaid) pay directly for tests. CDI offers payment plans and financial hardship programs for qualifying patients.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Transaction based/ take rate | Pay-as-you-go | Insurance-Covered Testing |
Go-to-market motion2 records
Distribution channels4 records
Marketing channels7 records
Commonwealth Diagnostics International product offering
Product offeringCore offering
Commonwealth Diagnostics International (CDI) provides non-invasive hydrogen and methane breath testing kits and CLIA-certified laboratory analysis services for diagnosing functional gastrointestinal disorders including Small Intestinal Bacterial Overgrowth (SIBO), Intestinal Methanogen Overgrowth (IMO), and carbohydrate malabsorption (fructose, lactose, sucrose). The offering is delivered through at-home or in-office test administration, a proprietary MyGI Gateway provider portal for ordering and result management, and direct insurance billing to Medicare, Tricare, and commercial payers on behalf of patients.
Product overview
Commonwealth Diagnostics International (CDI) offers a portfolio of non-invasive hydrogen and methane breath testing solutions for functional gastrointestinal diagnostics. The product line includes: the SIBO & IMO 10 Tube Breath Test (adult) available with lactulose or glucose substrates; the pediatric SIBO & IMO 6 Tube Breath Test with lactulose; and three carbohydrate malabsorption tests (Fructose, Lactose, and Sucrose malabsorption, each 6 Tube). All tests are supported by the MyGI Gateway platform, a provider-facing web portal for test ordering, data management, and result tracking. Tests can be administered at-home or in-office and are validated for clinical use in both adult and pediatric populations.
Differentiator
Problem solved
Functional benefit
Brands
- MyGI Gateway: Centralized hub for managing breath test data and insights, streamlining provider workflows and enhancing patient care through simplified breath testing data management.
Products and services
- SIBO & IMO Hydrogen and Methane 10 Tube Breath Test (Adult) Non-invasive at-home hydrogen and methane breath test for adult patients to diagnose Small Intestinal Bacterial Overgrowth (SIBO) and Intestinal Methanogen Overgrowth (IMO); available with lactulose or glucose substrate and 10-tube collection system.
- SIBO & IMO Hydrogen and Methane 6 Tube Breath Test (Pediatric) Clinically validated non-invasive hydrogen and methane breath test specifically designed for pediatric patients to detect SIBO and IMO using a 6-tube lactulose-based collection system.
- Fructose Malabsorption Hydrogen and Methane 6 Tube Breath Test Non-invasive diagnostic breath test for identifying fructose malabsorption in adult and pediatric GI patients by measuring hydrogen and methane gas produced by gut bacteria in response to unabsorbed fructose.
- Lactose Malabsorption Hydrogen and Methane 6 Tube Breath Test Diagnostic breath test for detecting lactose intolerance and malabsorption in adults and children by measuring hydrogen and methane emissions from gut bacteria reacting to lactose.
- Sucrose Malabsorption Hydrogen and Methane 6 Tube Breath Test Non-invasive breath test for diagnosing sucrose malabsorption in adults and children by detecting hydrogen and methane levels produced when sucrose is not properly metabolized.
- MyGI Gateway Provider Portal Centralized HIPAA-compliant web portal for healthcare providers to order breath test kits, track orders, and review patient results; available free to providers and integrated with CDI's diagnostic workflow.
Quantifiable outcome
- 1 business day turnaround time for test results
- +3 more outcomes
Companies that use Commonwealth Diagnostics International
Customer profileNamed customers4 records
Segments5 records
Ideal customer profiles2 records
Commonwealth Diagnostics International technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Commonwealth Diagnostics International partnerships and signals
Strategic signalPartnerships
Twelve partnerships are on record, tiered core, minor and flagship.
- RegencecoreExpanded in-network coverage with Regence across the Pacific Northwest and Intermountain Region, improving patient access to CDI's functional GI diagnostics.
- MedicacoreExpanded in-network coverage with Medica, strengthening access to affordable functional GI diagnostics across 12 states.
- U.S. Department of Veterans Affairs (VA) Community Care NetworkcoreCDI became an approved vendor on SAM.gov, expanding access to government and veterans healthcare networks through VA Community Care Network participation.
- Premera Blue CrosscoreExpanded in-network coverage with Premera Blue Cross, improving access for patients in the Pacific Northwest.
- CareFirst BlueCross BlueShieldcoreCDI now in-network with CareFirst BlueCross BlueShield and CareFirst BlueChoice, expanding patient access in the mid-Atlantic region.
- My Total HealthcoreStrategic partnership with My Total Health to provide comprehensive functional GI diagnostic solutions. My Total Health partners with the American College of Gastroenterology to provide scientific and clinical education to patients suffering from GI symptoms.
- Owlstone MedicalminorCDI ISO 13485-certified breath tests utilized in Owlstone Medical's study of normal levels of hydrogen sulfide in human subjects.
- Rupa HealthcorePartnership with Rupa Health to expand access to the naturopathic and integrative medicine community. Enables practitioners to order CDI breath tests through Rupa Health's platform.
- American College of Gastroenterology (ACG)flagshipACG partnership through My Total Health to provide scientific and clinical education to patients. CDI aligns with ACG Clinical Guidelines for SIBO diagnosis and treatment.
- Rome FoundationcoreOngoing partnership with Rome Foundation working towards cures for Disorders of Gut-Brain Interaction (DGBI). CDI participates in research and educational initiatives.
- University of MichiganminorCDI announced participation in clinical trial with the University of Michigan for functional GI research.
- Blue Cross Blue Shield of MassachusettscoreParticipation in Blue Cross Blue Shield of Massachusetts provider network for functional GI diagnostic services.
Scale indicators4 records
Recent moves6 records
Expansion highlights2 records
Commonwealth Diagnostics International competitors and assessment
Company assessmentBroad incumbents
- Quest Diagnostics: Quest Diagnostics is the largest US clinical laboratory offering thousands of tests across all major therapeutic areas. While functional GI breath testing is not a primary focus, Quest's scale and broad payer relationships make it the dominant incumbent reference lab against which CDI competes for commercial insurance volume.
- Laboratory Corporation of America (LabCorp): LabCorp is one of the two largest US clinical reference laboratories, offering an expansive specialty and routine diagnostics menu. Like Quest, LabCorp has the infrastructure to expand into functional GI breath testing and competes with CDI for hospital and physician office outreach.
- Eurofins Scientific: Eurofins operates a global network of clinical diagnostics laboratories, including specialty and functional medicine testing in the US. With its CE Mark and international regulatory footprint, Eurofins mirrors CDI's positioning on regulatory depth but at vastly greater scale.
- ARUP Laboratories: ARUP is a large nonprofit reference laboratory affiliated with the University of Utah, providing esoteric and specialty testing services to hospitals and physicians nationwide. ARUP represents the broad specialty reference lab category against which CDI positions for academic and large health system business.
- Sonic Healthcare: Sonic Healthcare is a global medical diagnostics operator with significant US laboratory operations including specialty testing. As a broad incumbent, Sonic could expand into functional GI breath testing given its existing infrastructure and payer contracts.
Direct peers
- Doctor's Data: Doctor's Data is a specialty reference laboratory focused on functional medicine testing, including breath tests for SIBO/IMO and malabsorption. They overlap with CDI's naturopathic and integrative medicine customer segment and compete for provider relationships in the functional GI space.
- Genova Diagnostics: Genova Diagnostics is a leading functional medicine laboratory offering a broad menu including hydrogen/methane breath testing for SIBO and carbohydrate malabsorption. They target the same gastroenterology and integrative medicine providers as CDI and serve as a primary competitor in functional GI diagnostics.
- Quintron Instrument Company: Quintron manufactures clinical gas chromatographic breath analyzers and supplies instruments used by functional GI testing labs and clinics. They are both a potential technology supplier and an adjacent competitor enabling in-office breath testing services.
- Gemelli Biotech: Gemelli Biotech offers the Trio Smart breath test for SIBO/IMO/H2S, the most directly comparable functional GI breath testing service to CDI in North America. They compete head-to-head for gastroenterology provider ordering and patient-direct business.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks5 records
Key highlights7 records
Customer concentration
Commonwealth Diagnostics International social profiles
Digital presenceCommonwealth Diagnostics International compliance and trust
Trust signalCompliance5 records
Commonwealth Diagnostics International financial estimates
Financial estimateRevenue estimate
Valuation estimate
Commonwealth Diagnostics International leadership team
Management profileNumber of profiles
Profiles1 record
Commonwealth Diagnostics International funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Commonwealth Diagnostics International M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Commonwealth Diagnostics International
What does Commonwealth Diagnostics International do?
Commonwealth Diagnostics International (CDI) provides non-invasive hydrogen and methane breath testing kits and CLIA-certified laboratory analysis services for diagnosing functional gastrointestinal disorders including Small Intestinal Bacterial Overgrowth (SIBO), Intestinal Methanogen Overgrowth (IMO), and carbohydrate malabsorption (fructose, lactose, sucrose). The offering is delivered through at-home or in-office test administration, a proprietary MyGI Gateway provider portal for ordering and result management, and direct insurance billing to Medicare, Tricare, and commercial payers on behalf of patients.
Is Commonwealth Diagnostics International a public or private company?
Commonwealth Diagnostics International is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Commonwealth Diagnostics International founded?
Commonwealth Diagnostics International was founded in 2017. It employs 101 to 250 people.
Where is Commonwealth Diagnostics International based?
Commonwealth Diagnostics International is headquartered in Salem, United States, in the North America region.
How does Commonwealth Diagnostics International make money?
Two revenue lines are on record. Diagnostic Testing Services are the primary driver. The others are direct Patient Payment.
Who are Commonwealth Diagnostics International's main competitors?
Broad incumbents on record are Quest Diagnostics, Laboratory Corporation of America (LabCorp), Eurofins Scientific, ARUP Laboratories and Sonic Healthcare. Direct peers are Doctor's Data, Genova Diagnostics, Quintron Instrument Company and Gemelli Biotech.
Does Commonwealth Diagnostics International have an API?
No public API is recorded for Commonwealth Diagnostics International.
What industry is Commonwealth Diagnostics International in?
Commonwealth Diagnostics International's product category is Functional GI Diagnostics. Its primary akta.pro industry code is HLAHAAAJ, Companion Diagnostics (CDx) & Precision Medicine IVD, with a secondary code of HLAKAEAA, General Gastroenterology. Its NAICS code is 621511 and its SIC code is 8071.