Summary & Overview
CPT 0525U: 3D Predict™ Ovarian Chemotherapy Response Assay
CPT code 0525U designates a Proprietary Laboratory Analyses (PLA) test — the 3D Predict™ Ovarian assay from Kiyatec® Inc. — that uses three-dimensional spheroid cell culture to predict ovarian, fallopian, or peritoneal tumor response to a panel of 11 chemotherapeutic drugs. Nationally, PLA codes like 0525U matter because they identify single-source, manufacturer- or lab-specific diagnostics that can affect coverage policy, lab utilization, and precision oncology workflows.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical context, how the service is typically delivered in laboratory and outpatient oncology settings, and the implications for treatment planning in ovarian and related cancers. The publication outlines reimbursement and coverage considerations at a national level, summarizes common modifiers and administrative details, and situates the test within the broader landscape of companion and predictive oncology diagnostics.
This report is intended to inform billing, coding, and policy teams about the nature of CPT code 0525U, its clinical purpose, and the operational settings where the service is performed. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0525U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the single commercial test 3D Predict™ Ovarian from Kiyatec® Inc. The assay uses 3D spheroid cell culture technology to evaluate how ovarian, fallopian, or peritoneal cancer cells respond to a panel of 11 chemotherapeutic agents, supporting personalized chemotherapy selection.
Service Type: Laboratory-based proprietary predictive chemotherapy response assay
Typical Site of Service: Clinical laboratory or specialty molecular diagnostics laboratory; sample collection typically occurs in outpatient oncology clinics or hospital outpatient settings
Clinical & Coding Specifications
Clinical Context
A typical patient scenario involves a woman with a recent diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who is being considered for systemic chemotherapy. Tissue or ascites-derived tumor cells are obtained at surgery or by image-guided biopsy and sent to the laboratory performing the 3D Predict™ Ovarian assay from Kiyatec® Inc. The assay cultures tumor cells in 3D spheroids and tests a panel of 11 chemotherapy agents to evaluate in vitro chemosensitivity and resistance. Results are returned to the treating gynecologic oncologist or medical oncologist to assist in selecting the most active agents or combinations for individualized treatment planning. Typical workflow steps include: specimen collection (operative or biopsy), specimen transport to the performing laboratory under proper chain-of-custody and temperature controls, laboratory processing and 3D culture, reporting of drug response profiles, and integration of results into the multidisciplinary treatment plan. Common sites of service are hospital outpatient laboratories, independent clinical reference laboratories, and academic pathology or molecular labs that handle specialized proprietary tests.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Standard primary procedure indicator | Use as the default when no other modifier applies and to indicate the primary service. |
22 | Increased procedural services | Use when there is a significantly greater complexity or effort in specimen processing or reporting beyond typical requirements. |
26 | Professional component | Use when billing only the professional component (interpretation and report) separate from the technical laboratory processing. |
52 | Reduced services | Use when testing is partially performed or a reduced service is provided compared with the full assay. |
53 | Discontinued procedure | Use if the laboratory testing was started but discontinued for documented clinical or technical reasons. |
TC | Technical component | Use when billing only the technical component (laboratory processing, culture, and assay) without the professional interpretation. |
59 | Distinct procedural service | Use when this proprietary assay is billed on the same day as other unrelated services to indicate distinct procedures. |
76 | Repeat procedure by same provider | Use when the same lab repeats the assay for the same patient for documented clinical reasons. |
77 | Repeat procedure by another provider | Use when a second laboratory repeats the assay performed earlier by a different provider. |
91 | Repeat clinical diagnostic laboratory test | Use for repeat testing of the same assay to confirm results when clinically indicated. |
QW | CLIA waived test (not applicable) | Not typically applicable; do not use for this complex PLA assay. |
Q0 | Investigational clinical service | Use only if the assay is performed under an investigational protocol that requires this modifier per payer policy. |
XE | Separate encounter (subset of 59) | Use to indicate a service performed during a separate encounter on the same date when payer requires a more specific modifier. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207VG0100X | Gynecologic Oncology | Treating specialist ordering and integrating assay results. |
| 207P00000X | Pathology | Pathologists overseeing specimen handling and interpretation when applicable. |
| 207L00000X | Medical Oncology | Medical oncologists ordering assay to guide systemic therapy choices. |
| 208D00000X | Clinical Laboratory | Laboratory directors and personnel performing the assay and technical components. |
| 207Q00000X | Surgical Oncology | Surgeons procuring tissue specimens and coordinating perioperative logistics. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C56.9 | Malignant neoplasm of ovary, unspecified | Primary indication for the 3D Predict™ Ovarian assay to evaluate chemosensitivity of ovarian tumor cells. |
C57.0 | Malignant neoplasm of fallopian tube | Applicable when tumor originates in the fallopian tube and tissue is tested for chemosensitivity. |
C48.1 | Malignant neoplasm of peritoneum | Primary peritoneal carcinoma cases use the assay to guide systemic chemotherapy selection. |
C79.31 | Secondary malignant neoplasm of ovary | Used when ovarian involvement is metastatic from another primary and chemosensitivity testing may inform treatment. |
Z85.43 | Personal history of malignant neoplasm of ovary | Relevant for recurrent disease assessment where repeat chemosensitivity testing may be considered. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88108 | Cytopathology, smears, interpretation | May be performed on cytology specimens (ascites or FNA) used to determine cellularity before sending material for the 3D assay. |
88305 | Surgical pathology, gross and microscopic examination | May be performed on resection or biopsy tissue that also supplies tumor for the 3D culture assay. |
36415 | Routine venipuncture for laboratory testing | May be performed when blood-based tests for baseline labs or paired correlative studies are required in the workup. |
84153 | Tumor marker assay (e.g., CA-125) | Commonly ordered alongside to monitor disease burden and correlate with chemosensitivity results. |
G0452 | Pharmacogenomic/pathology consultation code (example for molecular services) | May be used for formal molecular oncology consultation discussing assay results and therapeutic implications. |