Effective Date: April 22, 2026
Applies to: MDM™ Gut & Brain Health Test

Introduction

Thank you for considering the MDM™ (Microbial-Derived Metabolites) Gut & Brain Health test offered by Autism Diagnostics Lab. Before proceeding with testing, it is important that you understand what the test measures, its limitations, potential risks and benefits, and how the results will be used.

This informed consent document is designed to help you make an informed decision about whether to proceed with testing. Please read it carefully and discuss any questions with your healthcare provider before ordering the test.

Description of the MDM™ Gut & Brain Health Test

The MDM™ test is a Laboratory Developed Test (LDT) that analyzes microbial-derived metabolites in biological samples (typically stool) to identify metabolomic patterns that may be associated with autism spectrum disorder (ASD) and related neurodevelopmental conditions.

Test Purpose:

• To measure levels of specific microbial-derived metabolites in your sample
• To identify metabolomic patterns associated with gut-brain health
• To provide information that may support clinical assessment when used in conjunction with other diagnostic tools
• To identify potential biological imbalances that may inform treatment considerations

What the Test Is NOT:

• The test does NOT diagnose autism spectrum disorder on its own
• The test does NOT replace comprehensive clinical evaluation
• The test does NOT predict treatment outcomes
• The test does NOT determine the cause of symptoms
• The test is NOT FDA-cleared or approved

What the Test Measures

The MDM™ test uses advanced metabolomic analysis to measure concentrations of specific microbial-derived metabolites in your biological sample. These metabolites are produced by gut microorganisms and may influence various physiological processes, including:

• Neurotransmitter precursors: Compounds that may affect brain function and behavior
• Inflammatory markers: Indicators of immune system activity
• Metabolic byproducts: Substances produced during microbial metabolism
• Short-chain fatty acids: Important for gut health and immune function
• Other bioactive compounds: Various molecules that may impact health

The test analyzes these metabolites to create a comprehensive metabolomic profile that is compared against validated reference populations to identify patterns associated with autism spectrum disorder.

Test Performance and Limitations

It is critical that you understand the performance characteristics and limitations of this test before consenting to testing.

Test Accuracy:

Based on our validation studies in specific populations:

• Sensitivity: >90%. The test correctly identifies more than 90% of individuals in the study population who have ASD
• Specificity: 100%. In our validation studies, the test correctly identified all individuals without ASD (no false positives in the study population)

Possible False Positives:

A false positive result occurs when the test suggests metabolomic patterns associated with ASD in an individual who does not have ASD. While our validation studies showed 100% specificity, this does not guarantee the absence of false positives in all populations or circumstances. False positives may occur due to:

• Individual metabolic variations
• Dietary factors affecting metabolite levels
• Medications or supplements
• Gastrointestinal conditions affecting the microbiome
• Sample collection or handling issues
• Other medical conditions affecting metabolism

Possible False Negatives:

A false negative result occurs when the test does not detect metabolomic patterns associated with ASD in an individual who has ASD. With sensitivity >90%, approximately 10% or fewer of individuals with ASD in the study population had results that did not indicate ASD-associated patterns. False negatives may occur due to:

• Biological heterogeneity of autism spectrum disorder
• Individual metabolic differences
• Timing of sample collection
• Recent dietary changes or interventions
• Medication effects on metabolism
• Other factors affecting metabolite production

Other Important Limitations:

• Results represent metabolite levels at a single point in time and may vary over time
• The test has been validated in specific age groups and may perform differently in other populations
• Results must be interpreted in the context of complete clinical evaluation
• The scientific understanding of gut-brain metabolomics continues to evolve
• Results do not provide information about genetic factors
• The test cannot determine the severity of symptoms or predict outcomes

Risks and Benefits of Testing

Potential Benefits:

• Additional Information: The test may provide supplementary information to support clinical assessment
• Biological Insights: Results may identify metabolic imbalances that could inform treatment considerations
• Non-Invasive: Sample collection is simple and non-invasive (stool sample)
• Actionable Suggestions: The report includes potential interventions based on metabolomic findings
• Peace of Mind: For some individuals, additional testing provides reassurance or clarity

Potential Risks and Considerations:

• Emotional Impact: Test results may cause anxiety, stress, or emotional distress
• False Results: Possibility of false positive or false negative results leading to unnecessary concern or false reassurance
• Misinterpretation: Results may be misunderstood without proper professional interpretation
• Privacy Concerns: Health information will be collected, stored, and transmitted (though protected under HIPAA)
• Financial Cost: The test requires out-of-pocket payment ($349) and may not be reimbursed by insurance
• Delayed Diagnosis: Relying on test results without comprehensive clinical evaluation may delay proper diagnosis
• Unnecessary Interventions: Results might lead to interventions that are not medically necessary
• Uncertainty: Results may not provide definitive answers and may raise additional questions

Alternative Diagnostic Methods

Before deciding to use the MDM™ test, you should be aware of alternative and established methods for evaluating autism spectrum disorder:

Standard Clinical Evaluation:

• Comprehensive developmental history and assessment
• Standardized behavioral observation tools (ADOS-2, ADI-R)
• Evaluation by developmental pediatricians or child psychologists
• Multi-disciplinary team assessment
• Application of DSM-5 or ICD-11 diagnostic criteria

Other Assessments:

• Cognitive and developmental testing
• Speech and language evaluation
• Occupational therapy assessment
• Neurological examination
• Genetic testing (if indicated)
• Metabolic screening (if indicated)

The MDM™ test is not a replacement for these established diagnostic methods. It is intended to provide supplementary information that may be considered as part of a comprehensive clinical evaluation.

How Results Will Be Used

Your test results will be used in the following ways:

• Clinical Use: Results will be provided to you and your designated healthcare provider for clinical interpretation and consideration in the context of comprehensive evaluation
• Laboratory Quality Control: De-identified data may be used for internal quality assurance and test validation
• Research (with consent): If you provide separate authorization, de-identified data may be used for research to improve test performance and advance scientific understanding
• Regulatory Compliance: Data may be shared as required by law or regulation

Your results will NOT be:

• Shared with third parties without your authorization (except as required by law)
• Used for marketing purposes
• Sold to data brokers or other commercial entities
• Shared with employers, insurers, or schools without your authorization

Sample Collection and Handling Procedures

Understanding proper sample collection is essential for accurate results:

Sample Type:

The MDM™ test requires a stool sample collected using the sterile collection kit provided.

Collection Instructions:

• Follow all instructions provided in the collection kit carefully
• Collect sample at a consistent time of day when possible
• Avoid collection during acute illness, antibiotic use, or within 2 weeks of dietary changes (unless instructed otherwise by your healthcare provider)
• Store sample as instructed (typically refrigerated) until shipping
• Ship sample on the same day as collection or as specified in kit instructions
• Use provided shipping materials and follow shipping instructions

Sample Handling:

• Your sample will be processed in our CLIA-certified laboratory
• Samples are tracked using unique identifiers to protect privacy
• Samples are stored securely with controlled access
• Samples may be retained for quality control purposes or destroyed after testing as per our retention policy

Sample Integrity:

Results depend on proper sample collection and handling. If your sample is:

• Lost or damaged during shipping
• Improperly collected or stored
• Degraded or contaminated
• Insufficient in quantity

You may be asked to provide a new sample, or testing may not be possible.

Parental or Guardian Consent Requirement for Children

If the individual being tested is under 18 years of age, parental or legal guardian consent is required.

By consenting on behalf of a minor, you confirm that:

• You are the legal parent or guardian of the child being tested
• You have legal authority to consent to medical testing for the child
• You have read and understood this informed consent document
• You understand the purpose, limitations, risks, and benefits of the test
• You consent to sample collection, testing, and result reporting
• You will share results with the child's healthcare provider

Please see our Age Restriction and Parental Consent Policy for complete information about testing requirements for children.

Voluntary Nature of Testing

Testing is completely voluntary. You are under no obligation to proceed with the MDM™ test. Your decision whether or not to be tested will not affect:

• Your access to medical care
• Your relationship with healthcare providers
• Your eligibility for other services or evaluations
• Any other aspect of your care or rights

You should only proceed with testing if you:

• Have discussed the test with your healthcare provider
• Understand the purpose and limitations of the test
• Understand that results must be professionally interpreted
• Are comfortable with the risks and benefits
• Have had all your questions answered

Right to Refuse or Withdraw Consent

You have the right to:

• Refuse Testing: You may decline to proceed with testing at any time before sample collection
• Withdraw Consent Before Analysis: You may withdraw consent after sample collection but before laboratory analysis has been completed. Contact us immediately if you wish to withdraw consent.
• Decline to Receive Results: You may request not to receive test results (though this is not recommended as results may contain important health information)

Please note:

• Once laboratory analysis has been completed, results cannot be reversed, but you may choose not to receive or review them
• Refund policies apply to withdrawal requests (see our Refund Policy for details)
• If you withdraw consent, any samples collected will be destroyed in accordance with our policies

Questions and Additional Information

Before consenting to testing, make sure all your questions have been answered. You may ask questions about:

• The testing procedure and sample collection
• What the test measures and how results are interpreted
• Test accuracy, limitations, and potential errors
• Risks and benefits of testing
• Alternative diagnostic approaches
• How results will be used and protected
• Costs, billing, and refund policies
• Any other concerns you may have

For medical questions or to discuss whether this test is appropriate for your situation, please consult with your healthcare provider.

Consent Statement