Summary & Overview
CPT 0510U: Pancreatic Cancer Molecular Subtyping (PurIST?, Tempus AI Inc.)
CPT code 0510U designates a Proprietary Laboratory Analyses (PLA) test for PurIST? by Tempus AI Inc., an algorithmic assay that analyzes 16 genes from previously sequenced RNA whole–transcriptome data to estimate molecular subtypes of pancreatic cancer. As a PLA code, 0510U applies to a single commercial test and is intended to enable distinct tracking and reimbursement for this proprietary molecular diagnostic.
This code matters nationally because molecular subtyping can inform prognosis, clinical trial selection, and precision oncology workflows for pancreatic cancer — conditions driving growth in laboratory-developed and proprietary molecular tests. Key payers discussed in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
Readers will find a concise briefing on the clinical purpose of the assay, typical sites of service, and the implications of the PLA designation. The publication provides benchmarks and coverage patterns where available, summarizes relevant policy and coding considerations for proprietary molecular assays, and places the test in clinical context for oncology and pathology departments. Data not available in the input is explicitly noted where applicable.
Billing Code Overview
CPT code 0510U is a Proprietary Laboratory Analyses (PLA) code specific to a single test: PurIST? from Tempus AI Inc. The test uses algorithmic analysis of 16 genes from previously sequenced RNA whole–transcriptome data to report the probability of different molecular subtypes of pancreatic cancer.
Service Type: Laboratory — molecular/proprietary algorithmic analysis
Typical Site of Service: Clinical laboratory or pathology service that performs or analyzes previously sequenced whole–transcriptome RNA data; results are reported to ordering clinicians.
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with a pancreatic mass identified on imaging undergoes diagnostic workup including core needle biopsy with RNA whole–transcriptome sequencing. The treating oncology team orders the proprietary PurIST assay (0510U) from Tempus AI Inc. to analyze previously sequenced RNA whole–transcriptome data for expression of a 16-gene signature. The test reports probabilities for molecular subtypes of pancreatic ductal adenocarcinoma to inform prognosis and potential eligibility for subtype-driven clinical trials. Typical workflow: tissue acquisition and sequencing at a CLIA-certified lab; generation of whole-transcriptome RNA data; submission of sequencing files to Tempus for algorithmic analysis; reporting of subtype probabilities to the ordering oncologist. Typical site of service is a CLIA-certified molecular diagnostics laboratory with specimen acquisition occurring in an outpatient oncology clinic, hospital outpatient department, or interventional radiology suite. Common patient scenarios include newly diagnosed pancreatic adenocarcinoma, locally advanced disease under consideration for neoadjuvant therapy, or recurrent disease where molecular subtype may affect trial selection or prognosis estimation.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Placeholder / Not a standard CMS modifier for billing; included per input | Use only if payer-specific guidance requires this placeholder modifier (rare). |