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.
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.
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 International upholds rigorous testing standards to ensure the accuracy and reliability of its diagnostic services.
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.
Commonwealth Diagnostics International is well-recognized for its advanced diagnostic tests that cater specifically to identifying and managing gastrointestinal disorders.
The SIBO/IMO Lactulose Breath Test and the SIBO/IMO Glucose Breath Test are used by Commonwealth Diagnostics International to diagnose Small Intestinal Bacterial Overgrowth (SIBO) and Intestinal Methanogen Overgrowth (IMO).
When bacteria typically residing in the large intestine are found in the small intestine, it can lead to an overproduction of hydrogen and/or methane gas. This imbalance often results in gastrointestinal discomforts such as bloating, diarrhea, and constipation.
Traditionally, this condition is known as Small Intestinal Bacterial Overgrowth (SIBO), which has been further categorized based on the type of gas produced: hydrogen SIBO for hydrogen dominance, and methane SIBO for methane dominance.
However, recent guidelines have updated the classification, now identifying methane-related SIBO as Intestinal Methanogen Overgrowth (IMO). This change reflects the understanding that methane is actually produced by archaea, a type of microorganism distinct from bacteria.
The Hydrogen and Methane Breath Test is designed to diagnose both SIBO and IMO, and can be conducted using either lactulose or glucose substrates. Pediatric test kits are also available to accommodate younger patients.
The Fructose, Lactose, and Sucrose Malabsorption Breath Tests are designed to diagnose conditions associated with the inability to digest specific sugars due to enzyme deficiencies.
Lactose Malabsorption occurs when the body lacks the enzyme to process lactose, found in dairy products.
Similarly, Fructose Malabsorption arises from a deficiency in the enzyme required to metabolize fructose, commonly found in fruits.
Sucrose Malabsorption involves the inability to break down sucrose, or table sugar.
In each of these conditions, the absence of the necessary digestive enzymes allows bacteria in the gut to ferment these sugars, producing hydrogen and/or methane gas. This fermentation process can lead to gastrointestinal symptoms like bloating, diarrhea, and flatulence. These breath tests measure the levels of hydrogen and methane, helping to pinpoint the specific sugar malabsorption affecting the patient.
Recognizing the unique needs of younger patients, Commonwealth Diagnostics International provides the SIBO/IMO Pediatric Lactulose Breath Test, specifically designed for children.
This test diagnoses SIBO and IMO in pediatric patients, identifying excessive hydrogen and/or methane production that can lead to common gastrointestinal symptoms like bloating and diarrhea.
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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