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.

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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

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CPT 0525U: 3D Predict™ Ovarian Chemotherapy Response Assay

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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.

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.

Related Modifiers

8 rows

Modifier	Description	When to Use
22	Modifier –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…
26	Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…	- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
52	Modifier ‑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…
53	Modifier 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…
59	Modifier 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…
76	Modifier -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…
77	Modifier 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…
91	Modifier 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	Specialty	Notes
207P00000X	Emergency Medicine Physician	An emergency physician focuses on the immediate decision making and action necessary to prevent death or any further disability both in the pre-hospit…
207L00000X	Anesthesiology Physician	An anesthesiologist is trained to provide pain relief and maintenance, or restoration, of a stable condition during and immediately following an opera…
208D00000X	General Practice Physician	A physician who specializes in the general practice of diagnosing, treating, and managing patients with a variety of illnesses and conditions.
207Q00000X	Family Medicine Physician	Family Medicine is the medical specialty which is concerned with the total health care of the individual and the family. It is the specialty in breadt…
247200000X	Other Technician	A collective term for persons with specialized training in various narrow fields of expertise whose occupations require training and skills in specifi…
163WX0200X	Oncology Registered Nurse	Nursing Service Providers · Registered Nurse
246ZX2200X	Orthopedic Assistant	An Orthopaedic Assistant is a person who has been trained to work as a physician extender in both clinical and surgical environments. An Orthopaedic A…
183700000X	Pharmacy Technician	A person who works under the direct supervision of a licensed pharmacist and performs many pharmacy-related functions that do not require the professi…

CPT 0001U: PreciseType HEA Multiplex Erythrocyte Antigen Assay

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

CPT 0002U: Urine Metabolomic Polyp Risk Assay (PolypDX™)

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

CPT 0003U: Overa™ (OVA1 Next Generation) Ovarian Cancer Risk Assay

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

CPT 0005U: ExosomeDx Prostate (IntelliScore) Urine Gene Expression Risk 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 Panel, Gene Sequence Analysis

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: Cordant CORE™ 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 Transcript Testing

Showing 1–10 of 536

References

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.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.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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Clinical & Coding Specifications

Clinical Context

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.

Related Modifiers

8 rows

Modifier	Description	When to Use
22	Modifier –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…
26	Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…	- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
52	Modifier ‑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…
53	Modifier 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…
59	Modifier 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…
76	Modifier -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…
77	Modifier 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…
91	Modifier 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	Specialty	Notes
207P00000X	Emergency Medicine Physician	An emergency physician focuses on the immediate decision making and action necessary to prevent death or any further disability both in the pre-hospit…
207L00000X	Anesthesiology Physician	An anesthesiologist is trained to provide pain relief and maintenance, or restoration, of a stable condition during and immediately following an opera…
208D00000X	General Practice Physician	A physician who specializes in the general practice of diagnosing, treating, and managing patients with a variety of illnesses and conditions.
207Q00000X	Family Medicine Physician	Family Medicine is the medical specialty which is concerned with the total health care of the individual and the family. It is the specialty in breadt…
247200000X	Other Technician	A collective term for persons with specialized training in various narrow fields of expertise whose occupations require training and skills in specifi…
163WX0200X	Oncology Registered Nurse	Nursing Service Providers · Registered Nurse
246ZX2200X	Orthopedic Assistant	An Orthopaedic Assistant is a person who has been trained to work as a physician extender in both clinical and surgical environments. An Orthopaedic A…
183700000X	Pharmacy Technician	A person who works under the direct supervision of a licensed pharmacist and performs many pharmacy-related functions that do not require the professi…

CPT 0001U: PreciseType HEA Multiplex Erythrocyte Antigen Assay

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

CPT 0002U: Urine Metabolomic Polyp Risk Assay (PolypDX™)

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

CPT 0003U: Overa™ (OVA1 Next Generation) Ovarian Cancer Risk Assay

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

CPT 0005U: ExosomeDx Prostate (IntelliScore) Urine Gene Expression Risk 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 Panel, Gene Sequence Analysis

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: Cordant CORE™ 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 Transcript Testing

Showing 1–10 of 536

References

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.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.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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CPT 0525U: 3D Predict™ Ovarian Chemotherapy Response Assay

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Billing Code Overview

OpenPayer

CPT 0525U: 3D Predict™ Ovarian Chemotherapy Response Assay

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Billing Code Overview

Clinical & Coding Specifications

Clinical Context

Related Diagnoses

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Codes

References

Clinical & Coding Specifications

Clinical Context

Related Diagnoses

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Codes

References