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). |
22 | Increased procedural services | Use when documentation supports substantially greater work, time, or complexity in performing the laboratory analysis or reporting beyond typical test processes.
52 | Reduced services | Use when the full test is partially performed or truncated and documentation explains the reduction in service.
53 | Discontinued procedure | Use when the test process was started but discontinued due to patient or specimen issues, with documentation supporting the discontinuation.
59 | Distinct procedural service | Use when another unrelated procedure is billed on the same day and needs to be reported as distinct from the molecular test (payer rules may vary).
76 | Repeat procedure by same physician/lab | Use when the identical molecular analysis is repeated by the same performing lab for the same patient.
77 | Repeat procedure by another physician/lab | Use when the identical molecular analysis is repeated by a different performing lab.
90 | Reference (outside) laboratory | Use when the performing lab refers the specimen or analysis to an outside (reference) laboratory.
91 | Repeat clinical diagnostic laboratory test — same method | Use when the molecular test is repeated on the same day using the same method for verification purposes.
Q0 | Clinical diagnostic laboratory test (FDA-cleared/approved) | Use when payer requires Q0 for FDA-cleared/approved in vitro diagnostic tests (verify payer policy for PLAs).
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RH0000X | Hematology & Oncology | Medical oncologists commonly order tumor molecular profiling for treatment planning and trial eligibility. |
208800000X | Gastroenterology | Gastroenterologists and interventional endoscopists obtain pancreatic tissue samples and may initiate testing. |
207L00000X | Pathology | Anatomic and molecular pathologists oversee specimen handling, sequencing, and interpretation of molecular test results. |
363LF0001X | Clinical Laboratory Director | Laboratory directors manage CLIA-certified molecular testing workflows and result validation. |
208M00000X | Diagnostic Radiology | Interventional radiologists perform image-guided pancreatic biopsies that provide tissue for sequencing. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C25.9 | Malignant neoplasm of pancreas, unspecified | Primary indication for molecular subtype analysis to characterize pancreatic ductal adenocarcinoma. |
C25.4 | Malignant neoplasm of endocrine pancreas | Differentiation of tumor subtype may be relevant when confirming exocrine versus endocrine lineage and guiding testing selection.
C25.7 | Malignant neoplasm of pancreas, overlapping sites | Used when tumor spans multiple anatomic regions of the pancreas and molecular profiling is ordered for prognosis or trial eligibility.
C78.7 | Secondary malignant neoplasm of liver and intrahepatic bile duct | Common site of pancreatic cancer metastasis; molecular subtype information may inform systemic therapy choices.
Z85.07 | Personal history of malignant neoplasm of pancreas | Used in surveillance or recurrence workup where molecular profiling may be considered for recurrent disease.
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0510U | PurIST assay: algorithmic analysis of 16 genes from previously sequenced RNA whole–transcriptome data to report molecular subtype probabilities for pancreatic cancer | Primary PLA code for the PurIST proprietary molecular subtype analysis performed by Tempus AI Inc. |
88235 | Morphology evaluation; in situ hybridization (per specimen) | May be performed on biopsy material as part of ancillary molecular or cytogenetic evaluation before or alongside transcriptome testing.
88360 | Immunohistochemistry or immunocytochemistry, per specimen; initial single antibody stain | Performed on tissue specimens to characterize tumor markers that complement molecular subtype data.
81479 | Unlisted molecular pathology procedure | Occasionally used if another molecular analysis beyond the specific PLA is performed and no specific CPT exists; billing depends on payer rules.
0022U | Gene expression profiling test (example PLA) | Other PLA codes for molecular profiling may be performed alongside or as alternative assays; relationship depends on clinical and payer selection.