Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay

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:22 years or older, gender is not limitedSuspected of bladder cancer (including hematuria, inflammatory bladder, suspicious ultrasound results)Can receive standard of care, including urine cytology, cystoscopy, or surgery for bladder cancer diagnosisCan provide at least of 100 ml of urine (prior to cystoscopy or surgery)The assay specificity samples (some samples can overlap with non-cancer cases of the clinical validation group):Healthy volunteersGenitourinary benign diseasesGenitourinary cancer (non-bladder)Non-Genitourinary benign diseasesNon-Genitourinary cancerExclusion Criteria:1) History of urinary cancer 2) Neoadjuvant therapy-