A Guide to Understanding UroVysion and Cytology for Bladder Cancer

By Jane Meggitt

Early bladder cancer detection can make all the difference in the patient’s outcome. Fortunately, symptoms of bladder cancer often cause patients to seek prompt medical attention. Unfortunately, bladder cancer often recurs, so regular surveillance testing is a necessity.


The UroVysion® Bladder Cancer Kit, manufactured by Abbott Molecular of Des Plaines, Illinois,  is a fluorescence in situ hybridization (FISH) assay designed to detect frequent chromosomal abnormalities in bladder cancer. These abnormalities include polysomy for chromosomes 3, 7, and/or 17 and homozygous loss of band 21 on the short arm of chromosome 9 (9p21) in urine samples, as per Abbott Molecular.

The FDA originally approved UroVysion® initially for recurrent bladder cancer surveillance. Later, its use was extended for bladder cancer testing in patients with hematuria, or blood in the urine. It remains the sole molecular test for the initial diagnosis of bladder cancer as well as recurrence monitoring.

Abbott Molecular states that UroVysion® possesses a greater sensitivity in bladder cancer detection than cytology across all stages and grades. The test has the ability to detect tumors before they are visible based on chromosomal abnormality identification.

UroVysion® Study Results

Over the past decade, dozens of independent peer-reviewed studies and publications have attested to UroVysion®’s clinical efficacy.

For example, one study published in the October 2013 edition of Cancer Cytopathology of 1,835 paired urine samples with clinical and histologic correlation in the detection of urothelial cell carcinoma (UCC) in the same urine sample. The cases were divided into hematuria and surveillance groups. The former had no history of UCC, while the latter, as surveillance patients, did have such a history.

The study included “histologic and/or cystoscopic follow‐up within four months of the original tests” and three years of clinical follow-up. Of these 1,835 samples, 296 had atypical cytology. Of these, 95 were proven to have UCC. Sixty-one of the primarily higher-grade UCC were positive after using UroVysion® testing.

The study concludes, “In accordance with most of the previous studies, our data showed that UroVysion® test had higher sensitivity and lower specificity compared with cytology, although the sensitivity of UroVysion® was slightly lower than that in earlier studies.” While more sensitive than cytology in detecting UCC, UroVysion® also had more false positives.

Bladder Cancer Detection

Each year in the United States, approximately 73,000 new cases of bladder cancer are detected. Roughly 14,000 people succumb to the disease annually. Bladder cancer also has a high recurrence rate, ranging from 15 to 61 percent at one year and 31 to 78 percent at five years post-treatment. Because the recurrence rate is so high, bladder cancer patients require lifelong surveillance.

Bladder cancer symptoms include:

  • Blood in the urine
  • Changes in bladder habits
  • Painful urination
  • Frequent urination
  • Difficulty urinating

If bladder cancer remains undetected and spreads, symptoms may include:

  • Inability to urinate
  • Edema in the feet
  • Appetite loss
  • Weight loss
  • Bone pain
  • Fatigue
  • Pain on one side of the lower back

Doctors may recommend those at high risk for developing bladder cancer have regular screenings. These risk factors include a history of bladder cancer, exposure to certain chemicals, or birth defects associated with the bladder.

Bladder Cancer Testing

Testing for bladder cancer involves urine cytology. In this test, the pathologist analyzes cells from a urine sample under a microscope to look for any abnormalities. Many of the symptoms common in early bladder cancer mimic those of urinary tract infections. The presence of yeast or bacteria in the culture is generally indicative of infection, which should respond to antibiotic therapy. The pathologist looks for any pre-cancer or cancer cells in the sample.

When the UroVysion® test is positive but there are no other signs or symptoms of bladder cancer recurrence, the positive result may indicate that other cancers of the urinary tract are present. These include renal, prostate, urethra and ureter cancers.

Contact Us

At Yosemite Pathology and Precision Pathology, we offer a complete spectrum of bladder and cytology services. Our board-certified pathologists have received subspecialty fellowship training in urologic pathology. We offer urine cytology evaluation by Paris System, backed by reflex UroVysion® FISH molecular testing. Our turnaround time is 24 to 48 hours. We also provide advanced IT support and logistics. For more information about our services, contact us today.

Jane Meggitt’s work has appeared in dozens of publications, including USA Today, Zack’s, Financial Advisor, nj.com, The Houston Chronicle and The Nest. She is a graduate of New York University.


UroVysion Bladder Cancer Kit | Abbott Molecular

Tests for Bladder Cancer

Bladder Cancer Signs and Symptoms

Evaluation of UroVysion and Cytology for Bladder Cancer Detection: A Study of 1,835 Paired Urine Samples with Clinical and Histological Correlation (nih.gov)

Additional UroVysion Information | Abbott Molecular