Cytyc Corporation and Abbott Laboratories announced a collaboration and co-promotion agreement for the development and marketing of the ThinPrep UroCyte Slide Preparation System. Initial efforts will focus on modifying Cytyc's proprietary ThinPrep sample preparation technology to be used in conjunction with UroVysion, a DNA probe-based test for detection of bladder cancer recurrence. Both companies will promote this new system following completion and regulatory clearance of the co-developed product.
According to the National Cancer Institute, bladder cancer is the fifth most common cancer in the United States, with more than 600,000 Americans living with the disease, and 57,000 new cases and approximately 12,500 deaths each year. Bladder cancer has the highest recurrence rate of any cancer. It is estimated that as many as 70 per cent of cases will recur and, of those that do recur, as many as 30 per cent progress to a dangerous tumour.
"Clearly, the need to detect recurrence is vital," said Marek Skacel, MD, associate staff pathologist, Cleveland Clinic Foundation. "The ThinPrep UroCyte Slide Preparation System is an important advance. I believe that the laboratories that perform the UroVysion test will improve their efficiencies in terms of time and effort, while shortening the time to deliver the UroVysion result to the urologist treating the bladder cancer patient."
The most commonly employed methods for detecting bladder cancer recurrence are cystoscopy and urine cytology. However, on average, urine cytology can produce ambiguous or unclear results 45 per cent of the time. A variety of biomarker-based tests have attempted to address this situation. The UroVysion Bladder Cancer Recurrence Kit is the first and only FDA-cleared molecular urine cytology test that uses DNA probes to identify chromosomal abnormalities in patients previously diagnosed with bladder cancer (chromosomal change is the earliest event associated with cancer). In combination with cystoscopy, UroVysion offers the best available combination for detection of recurrent bladder cancer: the physician uses the cystoscope to visually detect cancer, while UroVysion identifies those bladder cells that exhibit chromosomal abnormalities - a key indicator of cancer.
"With UroVysion, we get the best available method to detect recurrence because it reliably identifies those DNA cellular changes that other non-invasive methods simply can't," said Steve Jones, MD, Section of Urological Oncology, Cleveland Clinic Foundation.
"Cytyc's ThinPrep technology is not only an improved method for cytology application but, importantly, has been shown to be an excellent platform for adjunctive testing, which we believe will help accelerate adoption of our UroVysion test and significantly improve medical care for patients with bladder cancer," said Rollie Carlson, Ph.D., vice president and general manager, Vysis Products, Abbott Laboratories."