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Reference Guide
Commonwealth Diagnostics International, Inc.

Commonwealth Diagnostics International, Inc.

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Commonwealth Diagnostics International, Inc.
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About the Lab

Commonwealth Diagnostics International (CDI) specializes in helping physicians identify and diagnose prevalent sources of digestive distress and functional gastrointestinal disorders.  

They have designed a comprehensive portfolio of diagnostic products and innovative technology solutions from a patient-first approach to help physicians identify common sources of digestive distress and functional gastrointestinal ailments.

About Commonwealth Diagnostics International (CDI)

Founded in 2015 in Salem, Massachusetts and operating out of its CLIA-certified laboratory and as an FDA-registered, ISO 13485-certified medical device manufacturer, CDI has partnerships with leading health systems, hospitals, and private practices worldwide.

CDI’s cost-effective portfolio of diagnostic solutions results in expedited treatment plans focused on patient-centric principles. It supports meaningful GI health outcomes with more precise and timely results from its experienced lab staff.

Its test portfolio includes non-invasive at-home hydrogen and methane breath tests for Small Intestinal Bacterial Overgrowth (SIBO) and Intestinal Methanogen Overgrowth (IMO), as well as fructose, lactose, and sucrose malabsorption to help providers identify and diagnose common sources of digestive distress and functional gastrointestinal ailments.

They ensure efficient sample processing, analytical precision, and quality assurance, all contributing to faster turnaround times for test results. Collaborating with a top-tier manufacturer in the gas chromatography (GC) sector, CDI has engineered a unique system that integrates custom-designed components, a dual-detector setup, and meticulously tailored method parameters. 

These innovations enhance the accuracy, precision, and sensitivity of their instruments, enabling them to effectively detect the three critical gasses in breath testing: hydrogen (H2), methane (CH4), and carbon dioxide (CO2).

CDI tests are easy-to-use, quick, and safe for patients and support meaningful GI health outcomes by helping steer each practitioner’s approach to dietary modification, homeopathic remedies, nutritional supplementation, immune support, high-quality probiotics, and additional testing.

The MyGiHealth App

CDI also provides access to MyGiHealth, a cloud-based, patient-focused healthcare application that enables patients to monitor, manage, and understand their symptoms while enhancing the patient’s relationship and communication with their integrated care team.  It is also used as a recruiting tool to find highly qualified patients for clinical trials.

Commonwealth Diagnostics Testing Standards

Commonwealth Diagnostics International upholds rigorous testing standards to ensure the accuracy and reliability of its diagnostic services.

Quality Assurance

CDI utilizes high-throughput gas chromatography (GC) systems, custom-built by Agilent Technologies. These systems offer a broader linear range compared to others in the market, spanning from 3 to 1000 ppm for hydrogen and methane, and 0.2 to 10% for carbon dioxide, maintaining over 90% accuracy across this range. 

The precision between samples is consistently within ±2 ppm for hydrogen and methane, and ±0.1% for carbon dioxide, aligning with the highest GC industry standards.

Their calibration practices are rigorously maintained using National Institute of Standards and Technology (NIST) traceable gas standards, ensuring the utmost accuracy in sample detection. They adhere to the North American Consensus for Breath Testing, the only standardized guidelines in the field, developed by 17 leading clinical scientists globally.

In quality management, their laboratory utilizes fully automated sample extraction to boost throughput and consistency. An exclusive collection tube preserves breath sample stability for up to two weeks, accommodating a broad temperature range (-4 to 104 °F). 

They also employ high-purity reference gasses to enhance detection limits by improving signal-to-noise ratios, ensuring that our instrumentation and technical staff performance consistently meet the highest standards of accuracy and precision.

Certifications and Accreditations

  • CLIA Certified
  • ISO 13485 Certificate
  • FDA Registered

About the Lab

CDI's at-home breath test kits for SIBO, IMO, and carbohydrate malabsorption help providers identify and diagnose common sources of digestive distress and functional gastrointestinal ailments.

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Quality Control Process

1 - 5 days
Shipment Tracking
Provides Tracking Number
Does Not Provide Tracking Number
Avg. Sample Processing
1 days
Consultation Availability
CLIA Certified
CAP Accredited
ISO 15189
COLA Accredited
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