Summary & Overview

CPT 0170U: Clarifi™ Saliva-Based Small RNA Panel for Early ASD Identification

Headline: New PLA CPT code 0170U identifies a saliva-based molecular panel for early autism screening

Lead: CPT code 0170U designates the Clarifi™ Proprietary Laboratory Analyses (PLA) test from Quadrant Biosciences, a saliva-based assay that measures 32 small RNAs and uses algorithmic analysis to support earlier identification of children at risk for autism spectrum disorder (ASD).

CPT code 0170U represents a single-manufacturer, proprietary molecular diagnostic service with potential implications for pediatric screening and early intervention programs nationwide. The code matters because PLA codes are reportable, specific to one test, and inform reimbursement, utilization monitoring, and clinical adoption for novel diagnostics.

Key payers covered include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a compact synthesis of what the code represents, payer coverage landscape, benchmarking topics relevant to proprietary diagnostics, and clinical context around saliva-based RNA panels for ASD. The publication provides actionable benchmarking categories (coverage policies, prior authorization trends, coding and billing considerations, and typical sites of service) and flags where further payer-specific policy details are required.

This summary is intended for a national audience of coding professionals, laboratory managers, clinicians involved in ASD screening, and policy analysts who need a concise reference on CPT code 0170U and its role in integrating a novel saliva-based small RNA panel into clinical workflows.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicareCPT 0170UProprietary Laboratory Analysesmolecular diagnosticsautism spectrum disordersaliva-based testsmall RNA panelalgorithmic analysispediatric screening

Billing Code Overview

CPT code 0170U is a Proprietary Laboratory Analyses (PLA) code for the Clarifi™ test from Quadrant Biosciences, Inc. The test is a saliva-based molecular panel that evaluates 32 small RNAs and applies an algorithmic analysis of results to enable earlier identification and intervention for children with autism spectrum disorder (ASD).

Service type: Proprietary laboratory molecular diagnostic test with algorithmic analysis

Typical site of service: Clinical laboratory or outpatient specimen collection site (saliva collection)

Clinical & Coding Specifications

Clinical Context

A 24-month-old toddler is brought to a pediatric developmental clinic by concerned parents who report delayed spoken words, limited eye contact, repetitive behaviors, and atypical social interactions. After a structured developmental screening (for example, Modified Checklist for Autism in Toddlers, Revised — M-CHAT-R) yields positive concerns, the clinician orders the Clarifi™ saliva-based proprietary laboratory test to support earlier identification of autism spectrum disorder (ASD) as part of a multi-modal evaluation. The clinical workflow includes: collection of a saliva specimen at the clinic or via a home collection kit per manufacturer instructions; shipment to the performing laboratory (Quadrant Biosciences, Inc.); laboratory analysis of a panel of 32 small RNAs and algorithmic interpretation; and return of a report that the ordering clinician integrates with behavioral observations, standardized developmental assessments, and family history to inform care planning and referral to early intervention services or specialty evaluation.

Typical site of service is an outpatient pediatric clinic, developmental-behavioral pediatrics practice, or collection performed at home with courier pickup. The service type is a proprietary laboratory analysis (PLA) for a diagnostic aid in early ASD identification. Common patient scenario: young child with developmental concerns undergoing multi-disciplinary evaluation where the Clarifi™ test provides adjunctive biologic information to guide early intervention decisions.

Coding Specifications

Modifier	Description	When to Use
`00`

Taxonomy Code	Specialty	Notes
2080S0001X	Pediatric Medicine	Pediatricians commonly order developmental testing and adjunctive laboratory diagnostics
208U00000X	Developmental-Behavioral Pediatrics	Specialists in ASD diagnosis and management who integrate PLA test results into evaluations
207K00000X	Family Medicine	Family physicians who manage early childhood development and coordinate referrals
2084P0800X	Clinical Molecular Genetics	Laboratory directors and molecular diagnostics specialists involved in test interpretation and reporting
208D00000X	Neurology	Pediatric neurologists who evaluate neurodevelopmental disorders and may order adjunctive tests

ICD-10 Code	Description	Clinical Relevance
`F84.0`	Autistic disorder	Primary diagnostic code for autism spectrum disorder; Clarifi™ is used as an adjunctive test to support earlier identification in children with suspected ASD.
`F80.9`	Developmental speech or language disorder, unspecified	Language delay is a common presenting feature prompting ASD evaluation and consideration of adjunctive testing.
`F82`	Specific developmental disorder of motor function	Motor abnormalities can co-occur with ASD and prompt comprehensive developmental assessment where adjunctive biomarkers may be considered.
`R62.0`	Delayed milestone in childhood	General code for developmental delay often used during early screening and evaluation when ordering supportive diagnostic tests.
`F84.5`	Asperger syndrome	Historically related autism spectrum condition; may be used in older coding contexts for ASD-spectrum diagnoses considered during evaluation.
`Z00.129`	Encounter for routine child health examination without abnormal findings	May be used when developmental surveillance during routine visits identifies concerns leading to further testing like the Clarifi™ assay.
`F95.1`	Chronic motor or vocal tic disorder	Behavioral presentations overlapping with ASD features; included when differential diagnosis warrants broader evaluation.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0170U`	Clarifi™ test — saliva-based panel of 32 small RNAs with algorithmic analysis for earlier identification of ASD (Proprietary Laboratory Analyses code)	This is the primary PLA code reported for the Clarifi™ assay performed by Quadrant Biosciences, Inc.
`82270`	Assay of carcinoembryonic antigen (CEA); multiple analytes — example molecular lab assay (general molecular pathology code)	Represents typical laboratory analytical service codes used for reporting biomarker assays when PLA codes are not applicable; included for workflow context though not a direct substitute.
`99000`	Handling and/or conveyance of specimen for transfer from the physician's office to a laboratory	Used when an office ships the saliva specimen to the performing laboratory and the payer recognizes specimen handling charges.
`G0473`	Specimen collection for SARS-CoV-2 — illustrative sample collection code	Included as an example of specimen collection coding; actual specimen collection for saliva assays may be reported per payer rules or bundled with the lab fee.
`84443`	Thyroid stimulating hormone (TSH) — example single analyte lab code	Serves as an example of commonly reported lab assay CPT codes; included to illustrate how standalone analyte codes differ from PLA codes.

When billing 0170U, the PLA code itself captures the analytic and algorithmic reporting performed by the specific lab. Ancillary codes for specimen handling or office services may be reported per payer policy. Use payer rules to determine allowed accompanying codes and modifier requirements.

OpenPayer