For clinicians & referring physicians
An objective biological layer in an evaluation that often relies on
An objective biological layer in an evaluation that often relies on
subjective observation alone.
The MDM™ Urinary Metabolite Panel is a laboratory-based screening aid for children ages 2 and older, measuring metabolic and microbial markers associated with autism spectrum conditions.
Designed to complement developmental surveillance, standardized screening, and clinical evaluation — not to replace them. Intended as adjunctive decision support for physicians already working within AAP/CDC-aligned pathways.
Adjunctive screening tool
Not a standalone diagnostic
CLIA-certified processing
Quality systems and proficiency testing
HIPAA-compliant PHI handling
End-to-end encryption, auditable logs
Physician-ordered testing
Requisition-based, reviewed workflow
7–10 business day TAT
From specimen receipt to signed report
Test framing
What this test is — and explicitly is not.
We lead with scope because bounded claims are the only ones a clinician can defensibly recommend.
What it is
An adjunctive, laboratory-based metabolic screening panel.
An objective data layer in a workup that otherwise relies heavily on subjective behavioral interpretation.
A decision-support input when the clinical picture is ambiguous, caregiver concern is rising, and evaluation is weeks or months away.
A non-invasive specimen — first-morning urine collected at home, with age-appropriate collection aids.
A physician-ordered test with signed requisition, interpretive report, and a defined action pathway.
What it is not
Not a diagnosis, not a substitute for clinical evaluation.
Not a diagnostic of autism spectrum disorder. Formal diagnosis remains a clinical determination based on developmental evaluation.
Not a replacement for AAP/CDC-recommended developmental surveillance or standardized screening tools (M-CHAT-R/F, SWYC, ASQ-3, etc.).
Not a standalone decision-maker. A flagged result does not confirm ASD; a typical result does not rule it out.
Not intended for population screening — it is intended for use where developmental concern has already been raised.
Clinical use cases
Where MDM fits in your practice.
The panel is most defensible as a second-line tool after developmental concern has already been documented — not as a first-line screen in well-child visits.
Developmental concerns already documented
The family or caregiver has raised concern, an M-CHAT-R or equivalent is abnormal or borderline, and you are weighing how much urgency to bring to the evaluation pipeline.
Long queue for developmental evaluation
A multi-month wait for developmental pediatrics or neurology. MDM offers an interim objective data point that may help calibrate the family's expectations and your clinical urgency.
Ambiguous presentation
Clinical picture does not clearly meet DSM-5-TR criteria and subjective variables dominate. An additional objective layer may inform shared decision-making with the family.
GI symptoms alongside developmental concerns
Children with overlapping GI complaints — chronic constipation, bloating, selective eating — and concurrent developmental or sensory concerns where metabolic markers may add context.
Workflow fit
How MDM sits inside existing pathways.
Designed to be additive, not disruptive — the test is ordered after a concern has been surfaced through standard developmental surveillance.
1
Standard surveillance & screening continue
M-CHAT-R/F at 18 and 24 months, ASQ, or equivalent developmental screen — performed as you normally would per AAP guidance.
2
Concern surfaces; referral is placed
When screening is positive or clinical concern is raised, your usual referral to developmental pediatrics, neurology, or child psychiatry is placed.
3
MDM is ordered as an adjunct — if appropriate
During the wait for evaluation (often 4–12 months), MDM may be ordered to provide an interim objective data point that can inform timing and inform shared decision-making with the family.
4
Result is interpreted within the full clinical picture
MDM result is documented in the chart and reviewed alongside history, screening scores, and behavioral observation — never in isolation. Specialist evaluation remains the standard for diagnosis.
Guardrail: MDM is not intended as a first-line screen in routine well-child visits. Its clinical utility is greatest when used after a developmental concern has already been raised.
Laboratory & compliance
The lab infrastructure behind each result.
Physicians recommend laboratories, not marketing. These are the systems that underwrite every report.
Regulatory
CLIA-certified processing laboratory
Quality systems and proficiency testing aligned with CMS CLIA requirements for moderate/high-complexity testing.
Methodology
LC-MS/MS-based urinary metabolite quantitation
Targeted panel of metabolic and microbially-derived markers, internal standards, and lot-level QA.
QA / QC
Multi-level control strategy
Daily QC, proficiency testing participation, lot-to-lot verification, and documented corrective action procedures.
Specimen stability
Stabilized at collection; validated handling
Collection kit includes preservative; validated for transport up to the stated stability window.
Interpretive report
Signed by a reviewing medical director
Each report is clinically reviewed; a licensed laboratory director is accountable for reported results.
Data governance
HIPAA-compliant PHI handling
Encrypted transmission, access-controlled storage, and auditable clinician/patient access logs.
Evidence summary
Transparent about the evidence base — including what it doesn't yet include.
We have chosen to publish the study design, cohort characteristics, and publication status rather than lead with performance claims out of context.
Study design
Retrospective, case-control
Children with confirmed ASD vs. age-matched controls; targeted urinary metabolite panel.
Cohort & age range
Pediatric cohort, 2+ years
Details of cohort size and demographics available upon request in the clinician brief.
Comparator
Clinically-characterized controls
Compared against age-matched neurotypical controls; no asymptomatic general-population arm.
Performance reporting
Contextual, not global
We report sensitivity, specificity, and predictive values only within the clinical context in which the panel was validated.
Publication status
Preprint — peer review in progress
Current public-facing manuscript is a preprint on Research Square. We disclose this openly to clinicians.
Ongoing work
External & multicenter extension
Prospective, multi-site replication and expanded external validation currently underway.
A note on marketing claims. We have intentionally retired high-salience performance claims from clinician-facing materials. Where performance figures are shared, they are presented with full study context, population, and limitations. If you have encountered stronger consumer-facing language, please request the clinical brief — that is the version written for your review.
Known limitations, stated up front
- Validation to date is based on a contained clinical cohort; pending replication in larger, independent, multi-site populations.
- Intended for use in children where developmental concern is already present; general-population screening performance is not established.
- No single biomarker panel can confirm or exclude autism spectrum conditions; full developmental evaluation remains the clinical standard.
- External, peer-reviewed clinical validation literature is still accumulating; additional publications are in progress.
Sample report
A report you can actually use in a clinical conversation.
Designed for physician review first — clear limits, clear intended use, clear next steps. Parent-readable summary is separated from the clinical data.
Quantitative biomarker panelEach marker reported with reference range, population context, and measurement uncertainty.
Overall pattern summaryTypical / atypical / indeterminate — with plain-language explanation of what the pattern does and does not imply.
Clinical interpretationSigned narrative from the reviewing medical director framed in the context of the child's documented clinical concern.
Explicit intended-use statementEach report reiterates that results are adjunctive and that diagnosis requires full clinical evaluation.
Action-oriented next stepsConsistent with pathway guidance below; never prescriptive, always deferred to the ordering physician's judgment.
Clinical action pathway
Result-by-result guidance — aligned with standard clinical judgment.
These pathways describe how most clinicians choose to act on results. Final management remains entirely at your clinical discretion.
Atypical pattern
Biomarker pattern outside typical range
Consistent with additional developmental/behavioral context already documented in the chart.
- Escalate or expedite pending referral for formal developmental evaluation.
- Discuss family-facing supports (early intervention referral as appropriate) during the waiting period.
- Document that diagnosis is not being made on the basis of this result alone.
Indeterminate
Mixed or borderline pattern
Result does not clearly fall within typical or atypical ranges; interpretation depends heavily on clinical context.
- Proceed with planned developmental evaluation on original timeline — result neither accelerates nor de-escalates.
- Consider repeat surveillance at a defined interval if symptoms evolve.
- Discuss with the family that no single test resolves all uncertainty.
Typical pattern
Biomarker pattern within typical range
This does not rule out ASD; clinical judgment and ongoing surveillance remain primary.
- Continue developmental surveillance per AAP guidance; do not cancel referrals based on this result alone.
- Document as one negative adjunct data point — clinical concern, if still present, should still drive evaluation.
- Offer structured re-check at the next developmental checkpoint if caregiver concerns persist.
Ordering workflow
From requisition to clinical report — four steps.
Straightforward to integrate; low overhead on clinic staff.
01
Clinician creates account & orders kit
A single online requisition is signed; kit is dispatched within 1 business day, either to your clinic or directly to the family.
02
Family collects specimen at home
First-morning urine, preserved in collection kit. Prepaid expedited shipping back to the lab — no clinic logistics burden.
03
Laboratory processing & review
LC-MS/MS analysis, QA/QC, and clinical review by the reviewing medical director — typical TAT 7–10 business days.
04
Clinician-first report delivery
Signed interpretive report returned to the ordering physician before the family-facing summary is released. You decide when and how to share.
Who we work with
Clinicians who find MDM most useful.
We are selective about who we invite into this workflow. The clinicians below tell us MDM adds the most to their practice — and we are equally clear about when it is not the right tool.
Primary-care pediatricians
Especially those with many families on long specialty waitlists, seeking defensible interim data.
Integrative / functional pediatricians
Clinicians already comfortable with gut-brain axis literature and adjunctive metabolic testing.
Autism-focused private practices
Multidisciplinary teams seeking an objective lab layer alongside behavioral assessment tools.
Clinicians seeing GI + developmental overlap
Where gut-related findings and developmental concerns coincide, the metabolic framing is most intuitive.
Physician FAQ
The questions clinicians actually ask us.
Short, honest answers. If you need deeper materials for EBM review, request the clinical brief.
No. MDM is a laboratory-based adjunctive screening tool that reports urinary metabolite and microbial markers. Diagnosis of autism spectrum disorder remains a clinical determination based on developmental evaluation by a qualified clinician. A result, whether typical or atypical, should never be used in isolation.
MDM sits downstream of standard surveillance and screening. AAP and CDC recommend developmental surveillance at every well-child visit and standardized autism screening at 18 and 24 months using validated tools such as M-CHAT-R/F. MDM does not replace these steps. It is positioned as an adjunct to consider after screening has surfaced concern and while the family awaits formal evaluation.
The primary publicly indexed manuscript describing the panel is currently a preprint on Research Square and is in peer review. External and multi-site validation work is ongoing. We disclose this status on clinician-facing materials because we consider it essential information for anyone being asked to recommend the panel. We will update this page as peer-reviewed publications are released.
We have intentionally moved away from high-salience performance figures in clinician-facing materials. Where sensitivity, specificity, or predictive values are presented, they are contextualized with study design, population, and limitations. If you have encountered stronger language elsewhere, please request the clinical brief — that document is written for clinical review and includes the caveats a physician would need.
All PHI is handled under a HIPAA-compliant framework. Specimens, results, and interpretive reports are stored with encryption at rest and in transit, access is role-based and auditable, and results are shared only with the ordering physician and, at the physician's discretion, the family. No results are disclosed to insurance or third parties without explicit written authorization.
The test is ordered by a licensed physician via requisition. The reviewing medical director at the laboratory signs the interpretive report. Final clinical interpretation and any downstream management decisions remain with the ordering physician, consistent with standard laboratory testing workflow.
Yes. We strongly encourage clinicians to review a sample report before placing an order. You can request it directly from the Sample Report section above or from the final call to action on this page.
We provide a clinician brief on request that includes the intended use, methodology summary, known limitations, publication status, and links to the preprint and ongoing validation work. We can also arrange a short peer-to-peer call with our medical director for groups considering integration into clinical workflow.
A suggested framing: "This is an additional lab test that measures certain chemicals in your child's urine that have been associated with autism-related patterns. It is not a diagnosis and it is not a replacement for the specialist evaluation we have scheduled. It is one more objective data point that can help us think about timing and next steps while we wait." The clinician brief contains additional family-facing language you are welcome to adapt.
Clinical brief
Review the evidence package, a sample report, and the intended-use framework — before you decide whether this belongs in your practice.
We'll send a concise, clinician-only packet. No marketing, no family-facing copy — just the materials you would need to form your own judgment.
What you'll receive
- Clinician brief: intended use, methodology, known limitations, and publication status.
- A fully-anonymized sample report in the exact format a physician receives.
- Preprint link, ongoing validation summary, and proactive disclosure of what is and isn't yet peer-reviewed.
- Optional peer-to-peer consult with our reviewing medical director.
© Autism Diagnostics Lab — MDM™ Urinary Metabolite Panel. For clinicians. Laboratory results do not constitute medical advice or diagnosis. The information on this page is intended solely for licensed healthcare professionals.
For clinicians
Request the clinical brief
A clinician-only packet — methodology, evidence package, sample report, and intended use framework.
