2025 CPT code 0366U
(Active) Effective Date: N/A Revision Date: N/A Laboratory - Multianalyte assays with algorithmic analyses (MAAA) Proprietary Laboratory Analyses Feed
Analysis of 10 protein biomarkers (A1AT, ANG, APOE, CA9, IL8, MMP9, MMP10, PAI1, SDC1, and VEGFA) in urine via immunoassay; algorithm determines probability of recurrent bladder cancer.
Modifiers may be applicable depending on payer-specific requirements and the context of service delivery. Consult payer guidelines for specific modifier use.
Medical necessity for 0366U is established when a patient has a history of bladder cancer and is undergoing surveillance for recurrence. The test aids in risk stratification, enabling timely intervention and improved patient outcomes.
The clinical responsibility involves ordering the test for appropriate patients (those with a history of bladder cancer and on surveillance protocols, without chronic kidney disease), interpreting the results in conjunction with other clinical findings, and tailoring treatment strategies accordingly. The laboratory is responsible for performing the assay and reporting the results.
In simple words: This lab test checks for recurrent bladder cancer. It uses a urine sample to measure levels of 10 proteins, then uses a computer program to calculate the chance of the cancer coming back.
This CPT code 0366U, Oncuria® Monitor, represents a proprietary laboratory analysis (PLA) for the detection of recurrent bladder cancer.The test utilizes a multiplex immunoassay to measure the levels of ten specific protein biomarkers (A1AT, ANG, APOE, CA9, IL8, MMP9, MMP10, PAI1, SDC1, and VEGFA) in a urine specimen. An algorithm incorporates these biomarker levels along with patient demographics (age, race, gender) to calculate a probability score indicating the likelihood of bladder cancer recurrence. The test is performed by DiaCarta Clinical Lab, DiaCarta Inc.
Example 1: A 65-year-old male patient with a history of bladder cancer, currently in remission, undergoes routine surveillance.His physician orders the Oncuria® Monitor (0366U) test to assess the probability of recurrence., A 72-year-old female patient with a past history of bladder cancer is experiencing hematuria.Her urologist orders the 0366U test to help determine if the hematuria indicates recurrence., A 58-year-old patient recently completed bladder cancer treatment.Their oncologist uses the 0366U test as part of a comprehensive follow-up strategy to assess the risk of recurrence and adjust treatment plans as needed.
* Patient demographics (age, gender, race).* Complete medical history, including prior bladder cancer diagnosis and treatment details.* Urine specimen collection date and time.* Results of the Oncuria® Monitor test.* Clinician's interpretation of results and subsequent treatment plan.
** This code is subject to CLIA edits.Facilities must meet CLIA requirements for performing and billing for this test.The accuracy of the code's application is maintained by the original applicant (DiaCarta, Inc.).
- Payment Status: Active
- Modifier TC rule: No TC modifier is applicable to this code, as it represents a complete laboratory analysis.
- Specialties:Urology, Oncology
- Place of Service:Laboratory