Summary & Overview
CPT 0335U: IriSight™ Prenatal Whole Genome Analysis — Proband
CPT code 0335U designates the IriSight™ Prenatal Analysis – Proband, a proprietary whole genome sequencing test from Variantyx Inc. performed on fetal samples to detect genetic variants linked to fetal or pregnancy clinical findings and rare heritable disorders. As a PLA code, 0335U applies exclusively to this single manufacturer's test, which has implications for coding accuracy, laboratory billing, and payer recognition nationally.
Key payers included in the analysis are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise explanation of the test’s clinical purpose and service setting, the implications of PLA designation for reimbursement and prior authorization workflows, and what to expect when billing this code to major national payers.
This publication provides national-level benchmarks and policy context relevant to proprietary laboratory tests, outlines common payer considerations for coverage and claims processing, and summarizes clinical context for prenatal whole genome sequencing. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0335U is a Proprietary Laboratory Analyses (PLA) code for the IriSight™ Prenatal Analysis – Proband offered by Variantyx Inc. The test is a whole genome sequencing analysis performed on a fetal sample to identify genetic variants that may be related to clinical fetal or pregnancy symptoms or that could indicate rare heritable disorders.
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Service type: Whole genome sequence analysis for prenatal/fetal genetic evaluation
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Typical site of service: Clinical diagnostic laboratory processing fetal specimens (prenatal diagnostic setting)
Data not available in the input for associated taxonomies, ICD-10 diagnoses, and related codes.
Clinical & Coding Specifications
Clinical Context
A pregnant patient at 18–24 weeks gestation, referred by a maternal-fetal medicine specialist after an ultrasound identifies fetal structural anomalies or when there is a family history suggestive of a rare heritable disorder. A fetal sample (amniotic fluid via amniocentesis or chorionic villus sampling) is collected and sent to Variantyx Inc. for IriSight™ Prenatal Analysis – Proband reported under 0335U. The laboratory performs whole genome sequencing of the fetal sample to identify single-nucleotide variants, insertions/deletions, copy-number variants, and other genomic findings that may explain observed fetal or pregnancy symptoms. Results are returned to the ordering clinician with a diagnostic report that may include pathogenic, likely pathogenic, and variants of uncertain significance relevant to fetal phenotype, guiding prenatal counseling and pregnancy management. Typical workflow steps: ordering by prenatal/genetics provider, informed consent and pre-test genetic counseling, invasive sample collection in an ambulatory surgical center or hospital, specimen transport to the performing lab, sequencing and bioinformatics analysis, post-test genetic counseling to review results with the patient and obstetric team.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | When reporting only the physician interpretation of results separate from the laboratory technical component (rare for PLA tests billed by performing lab). |