Last Updated: April 22, 2026

Laboratory Developed Test (LDT)

The MDM™ (Microbial-Derived Metabolites) Gut & Brain Health test is a Laboratory Developed Test (LDT) that has been developed, validated, and is performed by Autism Diagnostics Lab. This test is designed to measure specific microbial-derived metabolites in biological samples that may be associated with autism spectrum disorder (ASD) and related neurodevelopmental conditions.

FDA Status and Regulatory Information

The MDM™ test has not been cleared, approved, or authorized by the U.S. Food and Drug Administration (FDA). As a Laboratory Developed Test, the MDM™ is regulated under the Clinical Laboratory Improvement Amendments (CLIA) as a high-complexity test. Our laboratories are CLIA-certified and meet all applicable regulatory requirements for performing laboratory-developed testing.

The FDA does not require premarket review or approval of Laboratory Developed Tests performed in a CLIA-certified laboratory. However, this means that the analytical and clinical validity of this test has not been independently evaluated by the FDA.

Not a Standalone Diagnostic Device

The MDM™ test is not intended to be used as a standalone diagnostic device for autism spectrum disorder or any other medical condition. The test results should be considered as one component of a comprehensive clinical evaluation and should never be used in isolation to make diagnostic or treatment decisions.

The test provides information about metabolomic biomarkers that may be associated with ASD, but it:

• Does not diagnose autism spectrum disorder
• Does not confirm or rule out ASD on its own
• Does not predict the severity or trajectory of symptoms
• Does not determine treatment efficacy or outcomes
• Should not replace established clinical diagnostic criteria and procedures

Interpretation by Qualified Healthcare Provider Required

All test results must be interpreted by a qualified healthcare provider who is familiar with the patient's complete medical history, clinical presentation, and other diagnostic findings. Healthcare providers who may appropriately interpret MDM™ test results include:

• Developmental pediatricians
• Child psychiatrists and psychologists
• Pediatric neurologists
• Licensed clinical specialists in autism and developmental disorders
• Other qualified medical professionals with relevant expertise

Parents, caregivers, and patients should not attempt to interpret test results without professional guidance. The metabolomic data provided in the test report requires specialized knowledge to understand its clinical significance and limitations.

Not a Substitute for Professional Medical Evaluation

The MDM™ test is not a substitute for comprehensive professional medical evaluation, clinical assessment, or established diagnostic procedures for autism spectrum disorder. Diagnosis of ASD requires:

• Comprehensive developmental and medical history
• Standardized behavioral observations and assessments
• Evaluation by qualified healthcare professionals
• Application of established diagnostic criteria (DSM-5, ICD-11)
• Consideration of differential diagnoses
• Multi-disciplinary clinical judgment

The MDM™ test may provide supplementary information but should never delay, replace, or supersede established clinical diagnostic procedures.

Test Limitations and Accuracy

Like all laboratory tests, the MDM™ test has inherent limitations that must be understood:

Analytical Limitations:

• Test results are dependent on proper sample collection, handling, and storage
• Sample degradation or contamination may affect results
• Metabolomic profiles can be influenced by diet, medications, and other factors
• Results represent a snapshot at a single point in time and may vary over time
• False positive and false negative results are possible

Clinical Limitations:

• The test has been validated in specific populations and may not perform equally across all demographic groups
• Sensitivity and specificity data are based on research studies and may vary in real-world clinical settings
• The relationship between metabolomic biomarkers and clinical outcomes is still being studied
• Individual variation in metabolic profiles is significant
• Results do not establish causation or mechanism of symptoms

Performance Characteristics:

Based on our validation studies, the MDM™ test has demonstrated sensitivity >90% and specificity of 100% in the study population. However:

• These statistics were derived from specific study populations and may not reflect performance in all clinical populations
• Individual patient results may not align with population-level statistics
• Performance may vary based on patient age, symptom severity, comorbidities, and other factors
• Ongoing monitoring and validation studies continue to refine our understanding of test performance

No Guarantee of Treatment Outcomes

Autism Diagnostics Lab makes no guarantees, warranties, or representations regarding treatment outcomes, clinical benefits, or health improvements that may result from using the MDM™ test or acting on its results.

The test provides information about metabolomic biomarkers but does not:

• Guarantee that any specific treatment or intervention will be effective
• Predict response to therapy or treatment outcomes
• Ensure improvement in symptoms or quality of life
• Replace the need for ongoing clinical monitoring and care
• Eliminate the need for other diagnostic or therapeutic interventions

Treatment decisions should be made by qualified healthcare providers based on comprehensive clinical evaluation, not solely on test results.

Research and Evolving Science

The field of metabolomics and its application to neurodevelopmental disorders is rapidly evolving. Our understanding of the relationship between metabolomic biomarkers and autism spectrum disorder continues to develop through ongoing research. Test methodologies, interpretation guidelines, and clinical recommendations may be updated as new scientific evidence emerges.

Individual Responsibility

By using the MDM™ test, you acknowledge that:

• You have read and understood this Medical Disclaimer
• You understand the limitations of the test
• You will share all test results with a qualified healthcare provider
• You will not make medical decisions based solely on test results
• You understand that the test is not FDA-approved and is a Laboratory Developed Test
• You accept responsibility for discussing results with your healthcare provider

Medical Emergency Disclaimer

Limitation of Liability

To the fullest extent permitted by law, Autism Diagnostics Lab, its affiliates, employees, directors, and agents shall not be liable for any direct, indirect, incidental, consequential, or special damages arising from the use of the MDM™ test, interpretation of test results, or any decisions made based on test results. This includes but is not limited to damages related to misdiagnosis, delayed diagnosis, treatment decisions, or health outcomes.

Questions and Additional Information

If you have questions about this Medical Disclaimer, the MDM™ test, its limitations, or how results should be interpreted, please contact us:

For medical questions about your specific situation or test results, please consult with your healthcare provider.