Summary & Overview
CPT 0421U: Colosense™ Fecal Molecular Colorectal Cancer Risk Test
CPT code 0421U denotes a Proprietary Laboratory Analyses (PLA) test reserved for Colosense™ by Geneoscopy Inc., a fecal molecular diagnostic that quantifies RNA expression of eight genes plus fecal hemoglobin and uses an algorithm to report positive or negative colorectal cancer risk. As a PLA code, 0421U applies only to this single manufacturer’s test, which matters for coding precision, payer recognition, and billing audit clarity nationwide. Nationally, PLA codes like 0421U are tracked for utilization, coverage determinations, and clinical validation as they represent proprietary assays that can influence screening pathways for colorectal cancer.
Key payers covered in typical analyses include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of the clinical purpose and laboratory service model, payer coverage considerations, available benchmarking and reimbursement context, and implications for coding and billing workflows. The publication outlines how the assay’s algorithmic result and unique PLA designation affect documentation, claims reporting, and interactions with laboratory and payer processes. Data limitations: Data not available in the input on utilization volumes, reimbursement amounts, and payer-specific coverage policies.
Billing Code Overview
CPT code 0421U is a Proprietary Laboratory Analyses (PLA) code specific to a single commercial test: Colosense™ from Geneoscopy Inc. The test is a fecal-based molecular assay that measures RNA expression of eight named genes and assesses fecal hemoglobin level. An integrated algorithmic analysis of those inputs generates a reported risk result of positive or negative for colorectal cancer.
Service type: Laboratory — molecular diagnostic stool assay
Typical site of service: Clinical laboratory or reference laboratory with receipt of patient fecal specimen; sample collection may occur at home with subsequent lab processing
Clinical & Coding Specifications
Clinical Context
A 58-year-old average-risk patient with intermittent rectal bleeding and a family history of colorectal cancer requests noninvasive screening. A primary care physician orders the Colosense™ fecal test (0421U) provided by Geneoscopy Inc. The patient collects a stool sample at home using the manufacturer kit and returns it to the designated laboratory or mails it per kit instructions. The laboratory performs RNA expression analysis of the eight specified genes and measures fecal hemoglobin, runs the proprietary algorithm, and issues a report indicating risk of colorectal cancer positive or negative. Results are routed to the ordering clinician who documents test interpretation, discusses risk and next steps (for example, colonoscopy referral if positive), and files the report in the medical record. Typical site of service is outpatient ambulatory care with sample collection at home and analysis in a clinical laboratory specializing in molecular diagnostic testing.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default primary identifier (no modifier) | Use when no specific modifier applies to the laboratory PLA service |
26 |