When the American Urological Assocation (AUA; Linthicum, Maryland) has its annual meeting in Atlanta beginning Friday, among the presenters will be a representative from Abbott Molecular (Des Plaines, Illinois) to report results of a new study on its UroVysion DNA test for bladder cancer.

The UroVysion diagnostic received initial clearance from the FDA as a Vysis (Downers Grove, Illinois) product in August 2001 to monitor for the recurrence of bladder cancer. Abbott ultimately acquired Vysis in December 2001 following the initial announcement of the acquisition in October of that year.

"It's not a screening test … it's for detection of bladder cancer in patients who are suspected of having bladder cancer," Timothy Stenzel, MD, PhD, medical director of Abbott Molecular and senior author of a paper that will be presented at the conference on UroVysion, told Diagnostics & Imaging Week.

"We did an analysis of almost 700 patients, and we showed that each single probe increased the sensitivity in a very significant way," he said, noting that not all the chromosomes identified with probes on the assay demonstrate a change in all cases of bladder cancer.

Abbott will be making several presentations at the AUA annual meeting. In a study published in Urology in March by Stephen Jones, MD, of the Glickman Urological Institute of the Cleveland Clinic Foundation (Cleveland), Jones found that FISH (fluorescence in situ hybridization) technology outperformed cytology in "all stages and grades" of urothelial cancer and it "detected malignancy" before cystoscopy was able to identify lesions.

"It is apparent that we are in the early phases of realizing the potential of molecular diagnostics," the abstract for the study explained.

In January 2005, the test received FDA clearance – in addition to monitoring for the recurrence of bladder cancer – for detecting bladder cancer in patients who present with blood in the urine.

Now, Abbott wants to make the test the "gold standard" as the only DNA-based test of its kind for bladder cancer.

"The reason we believe we can make this the gold standard is that the tried and true method [up to now] has been cytology and ancillary tests to help the urologist," Stenzel said. "But in all studies across all grades across all stages of bladder cancer, molecular cytology – this FISH test" maintains a very high specificity, much like cytology."

Stenzel added that "sales are doubling about every year on the product, so it's growing quite fast.

"We're confident that all urologists are now aware of this new DNA-based diagnostic test, and we have a lot of repeat customers," Stenzel said. "We [also] have a lot of people who are just trying it out now to see if they like it."

Abbott has a dedicated sales force "to help educate" urologists, he said.

"We're very hopeful about this product," he said, but also acknowledged that it can take a long time to change physician behavior.

Abbott's FISH technology is designed to detect subtle buy key genetic changes in bladder cells. The test measures DNA on four different chromosomes, since there is a genetic basis for bladder cancer.

Stenzel described UroVysion as "really a combination test," since it is slide-based and measures both morphologic changes and changes seen with fluorescent light. That combination allows someone to look to determine whether the nuclei are abnormal, as well as "counting the chromosomes in those nuclei."

Stenzel said it's the "only molecular test that's FDA-approved and measures specific chromosome events."

When it comes to reimbursement for the test, Abbott has had some "pushback" from "some, very small" segments regarding the number of probes, according to Stenzel.

The American Cancer Society (Atlanta) estimates that in 2006 there will be about 61,000 new cases of bladder cancer diagnosed in the U.S, the majority predominantly male: 45,000 men vs. 17,000 women. It estimates about 600,000 in the U.S. living with diagnosed bladder cancer.

About 50% of patients will experience a recurrence within two years after an initial diagnosis. Therefore, the high rate of recurrence requires that patients be monitored frequently for potential recurrence.

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