Summary & Overview
CPT 0410U: Avantect Pancreatic Cancer Test, 5hmC Profiling and WGS
Headline: New PLA CPT code 0410U designates the Avantect™ Pancreatic Cancer Test, a blood‑based assay using 5‑hydroxymethylcytosine (5hmC) profiling and whole‑genome sequencing to evaluate patients at high risk for pancreatic cancer.
Lead: CPT code 0410U identifies a single‑manufacturer laboratory test—Avantect™ from ClearNote™ Health—that analyzes 5hmC biomarkers and performs whole‑genome sequencing on a blood specimen to aid earlier detection of pancreatic cancer in high‑risk patients. As a Proprietary Laboratory Analyses (PLA) code, 0410U applies only to this specific test.
Why it matters: Early detection of pancreatic cancer remains a national clinical priority due to typically late-stage presentation and poor prognosis. A PLA code such as 0410U provides a clear billing identifier for a novel, manufacturer‑specific diagnostic that may influence coverage policies, prior authorization workflows, and lab reporting.
Payers covered: Analysis highlights national payers including Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
What readers will learn: The publication outlines the clinical purpose of CPT code 0410U, the service context and typical sites of service, payer landscape and potential coverage considerations, and how this PLA code fits into laboratory billing practice. It also summarizes common billing modifiers associated with laboratory procedural reporting. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0410U is a Proprietary Laboratory Analyses (PLA) code assigned to the Avantect™ Pancreatic Cancer Test from ClearNote™ Health. The test profiles 5–hydroxymethylcytosine (5hmC) biomarkers and uses whole–genome sequencing on a patient blood specimen to evaluate individuals at high risk of developing pancreatic cancer. The assay is intended to help identify pancreatic cancer earlier than some common testing methods and to indicate potential follow–up diagnostic pathways.
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Service type: Diagnostic laboratory testing using biomarker profiling and whole–genome sequencing
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Typical site of service: Clinical laboratory or outpatient phlebotomy site
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with a family history of pancreatic cancer and new-onset, unexplained diabetes presents to a gastroenterologist after imaging and routine laboratory tests are inconclusive. The clinician identifies the patient as high risk for pancreatic neoplasm based on age, familial predisposition, and clinical features (weight loss, epigastric pain, or recent diabetes). After counseling about diagnostic options, the clinician orders the Avantect™ Pancreatic Cancer Test (Proprietary Laboratory Analyses code 0410U) to evaluate circulating 5–hydroxymethylcytosine (5hmC) patterns and whole-genome sequencing from a peripheral blood specimen.
The clinical workflow: the outpatient clinic or oncology infusion/lab collection site collects a blood specimen following the test manufacturer’s kit instructions and ships it to ClearNote™ Health. The laboratory performs the proprietary 5hmC biomarker profiling and sequencing, generates a report indicating risk stratification for pancreatic cancer, and returns results to the ordering provider. Based on results, the provider determines next steps such as cross-sectional imaging (CT or MRI), endoscopic ultrasound with possible biopsy, referral to surgical oncology, or routine surveillance.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default; no modifier | Use when no special circumstances apply to the billed service |