Protocol amendment.

The AnchorDx UriFind™ Bladder Cancer Assay is designed to detect 2 DNA methylation biomarkers in urine specimens from patients 22 years or older suspected of having bladder cancer. Results from the assay are intended for use, in conjunction with current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients.

Inclusion Criteria:

Clinical Validation Group:

1. 55 years or older, gender is not limited
2. Suspected of bladder cancer and are scheduled for bladder biopsy or trans-uretheral resection of bladder tumor (TUBRT)
3. Can receive standard of care, including urine cytology, cystoscopy, or surgery for bladder cancer diagnosis
4. Can provide at least of 75 ml of urine (prior to cystoscopy or surgery)

Exclusion Criteria:

1. History of urinary cancer
2. Neoadjuvant therapy

The clinical validation group is to assess the safety and effectiveness of the AnchorDx UriFind™ Bladder Cancer Assay in an intended use population to establish the expected performance in the product labeling. The study also aims to provide performance evidence of the AnchorDx UriFind™ Bladder Cancer Assay in adequate number of early-stage and low-grade cases.