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    v1.0.31
    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0510u-pancreatic-cancer-molecular-subtyping-purist-tempus
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    CPT 0510U: PurIST Pancreatic Cancer Molecular Subtyping Assay

    CPT code 0510U is a Proprietary Laboratory Analyses (PLA) code for the PurIST? assay from Tempus AI Inc., a laboratory test that uses algorithmic analysis of 16 genes from previously sequenced RNA whole–transcriptome data to report the probability of molecular subtypes of pancreatic cancer; service type: genomic algorithmic analysis (proprietary molecular diagnostic assay); typical site of service: clinical diagnostic laboratory or reference lab using previously obtained sequencing data.

    For related coverage guidance, see recent payer policy updates: Minimal Residual Disease (MRD) Testing for Cancer, Biomarker Testing Mandate, Prenatal (Fetal) Diagnostic Testing.

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    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.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    0510UPurIST assay: algorithmic analysis of 16 genes from previously sequenced RNA whole–transcriptome data to report molecular subtype probabilities for pancreatic cancerPrimary 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.

    Related Modifiers

    8 rows

    ModifierDescriptionWhen to Use
    22Modifier –22 (Increased Procedural Services) is used when a reported procedure is substantially more extensive than normally required. The CPT Manual and CMS state it may be appended only when the…- When to use: Append modifier -22 to a procedural CPT code when the service performed is substantially more extensive than the usual service described by that code — i.e., the procedure required…
    52Modifier ‑52 (Reduced Services) indicates that a service or procedure was partially reduced or omitted at the provider’s discretion, allowing reporting of the basic procedure number with a qualifier…- Use modifier -52 when a physician or qualified health professional electively reduces or omits part of a procedure or service (for example, performing fewer required views or omitting a portion of…
    53Modifier 53 (Discontinued Procedure) signals that a surgical or diagnostic service was begun by the physician but terminated because of extenuating circumstances that threatened the patient’s…- Use modifier -53 when a physician/qualified healthcare professional has started a surgical or diagnostic procedure (e.g., anesthesia administered, incision or scope insertion) and then discontinues…
    59Modifier 59 indicates a distinct procedural service when two procedures that are not normally billed together are clinically and procedurally separate. The CPT definition (as reiterated by CMS)…- Use modifier -59 to report a distinct procedural service when documentation supports that the procedure reported is not normally billed together with another service on the same day because of a…
    76Modifier -76, Repeat Procedure or Service by Same Physician or Other Qualified Health Care Professional, is appended when the same provider performs an identical, medically necessary procedure or…- Use modifier -76 when the same physician or other qualified health care professional performs an identical procedure or service a second (or subsequent) time on the same date of service and the…
    77Modifier 77 indicates that a previously performed procedure or service was legitimately repeated by a different physician or other qualified health care professional. The AMA’s CPT definition…- Use modifier 77 when a basic procedure or service already performed is repeated by a different physician or other qualified health care professional (for example, a second provider independently…
    90Modifier ‑90 (Reference/Outside Laboratory) indicates that a laboratory test was performed by an entity other than the treating or reporting provider. The American Medical Association defines…- Use CPT modifier -90 when a laboratory test is performed by an outside/reference laboratory (an entity other than the treating or reporting physician or qualified professional) and the claim needs…
    91Modifier 91 — “Repeat Clinical Diagnostic Laboratory Test” — is appended when the exact same CPT laboratory test is performed more than once for the same patient on the same day because serial,…- Use modifier 91 when the exact same CPT laboratory test is performed more than once on the same patient on the same date because serial or repeated testing is medically necessary to monitor…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    207RH0000X
    208800000X
    207L00000X
    208M00000X
    246Q00000X
    405300000X
    2083T0002X
    225CA2400X

    Related Payer Policy Updates

    Specialty: Genetic & Molecular Testing1 / 3

    10 rows

    PolicyPayerEffective Date
    Minimal Residual Disease (MRD) Testing for Cancerregence2027-01-01
    Biomarker Testing MandateBlue Cross Blue Shield - Rhode Island2027-01-01
    Prenatal (Fetal) Diagnostic TestingBlue Cross Blue Shield - Rhode Island2027-01-01
    Oral Cancer Screening and TestingOscar Health2027-01-01
    RTM Testing for Alpha-1 Antitrypsin DeficiencyOscar Health2027-01-01
    Cytochrome P450 Genotype-Guided Treatment Strategy Corporate Medical Policybcbsvermont2027-01-01
    Polygenic Risk ScoreBlue Cross Blue Shield - Rhode Island2026-12-01
    Gene Expression Profiling for Cutaneous MelanomaBlue Cross Blue Shield - Rhode Island2026-12-01
    Genetic Testing for Macular Degenerationregence2026-11-01
    Pharmacogenetic Panel Testing (for Ohio Only)Colorado Rocky Mountain Health Plans2026-11-01

    Related Codes

    CPT-0001U-PRECISETYPE-HEA-MULTIPLEX-RBC-ANTIGEN-GENOTYPING

    CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

    CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

    CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

    CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

    CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

    CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

    CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression test

    CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

    CPT 0007U: ToxProtect Urine Drug Screen With DNA Authentication

    CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

    CPT 0008U: H. pylori Antibiotic Resistance Gene Panel

    CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

    CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

    CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

    CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

    CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

    CPT 0011U: Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

    CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

    CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcripts

    Showing 1–10 of 536

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    Frequently Asked Questions

    References

    1. 1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
    2. 2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
    3. 3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.
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