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. |