Evaluating Bladder CARE™, a New Non-Invasive Urine Test, for Bladder Cancer Detection in Inconclusive Cases

Prospective Evaluation of Bladder CARE™ Assay Utility for the Diagnosis of Bladder Cancer in Patients With Atypical Cytology or Equivocal Cystoscopy

The goal of this observational study is to learn about the performance of the Bladder CARE™ Assay in patients suspected of having bladder cancer with atypical cytology or equivocal cystoscopy results. The main question it aims to answer is:

• Does the Bladder CARE™ Assay detect bladder cancer in patients who have inconclusive cytology or cystoscopy results?

Participants will provide one voided urine specimen on the day of, and prior to, the routine, scheduled standard of care initial or repeat cystoscopy procedure. A medical records review will occur at two follow-up timepoints, (6 months and 12 months after the urine specimen collection), to document oncology-urinary-related clinical outcomes.

Inclusion Criteria:

1. Patients ≥ 18 years of age at time of informed consent.
2. Subject or the subject's legally authorized representative provides written informed consent.
3. Subject is willing to follow all study procedures and available for the duration of the study.
4. Patients with atypical cytology or equivocal cystoscopy results within 3 months before screening.
5. Subject is scheduled for initial or repeat cystoscopy, with or without pathology.
6. Subject is willing to provide one voided urine specimen of at least 80 ml on the same day, but prior to scheduled initial or repeat cystoscopy, with or without pathology.

Exclusion Criteria:

1. Pregnant or planning to become pregnant at the time of screening.
2. Positive cystoscopy within 3 months of screening indicating presence of bladder cancer.
3. Genitourinary manipulation (flexible or rigid cystoscopy, catheterization, urethral dilation, URS, ureteral stent) within 14 days before urine specimen collection.
4. History of augmentation cystoplasty.
5. History of continent cutaneous diversion or ileal conduit.
6. History of orthotopic bladder substitution or orthotopic neobladder.
7. Concomitant use of an investigational drug which has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of urine specimen.
8. New or recurrent NMIBC (non-muscle invasive bladder cancer) diagnosis within three months of study enrollment.
9. An active malignancy (bladder or other) diagnosis within 3 months of study enrollment.
10. Patients with a history of NMIBC have undergone intravesical or infusion therapy and completed treatment less than 6 weeks prior to study enrollment.