Test to detect bladder cancer Cysview coming

Cysview, a fluorescence-based test to detected bladder cancer, is coming.

Cysview cystoscopy is the first approved drug-device procedure for improved detection of bladder cancer.

It is designed to induce fluorescence in the malignant cells in the bladder during a cystoscopic procedure, making it easier for the urologist to detect bladder cancer.

Cysview is the first product in a new diagnostic class known as photodynamic detection (PDD) agents. Cysview must be used with a blue light cystoscopy system from Karl Storz procedure for detection of papillary bladder cancer.

Data from the pivotal 305 trial showed that Cysview cystoscopy significantly improves detection of papillary bladder cancer.

This could allow more complete resection of bladder cancer and significantly improve disease-free survival when compared to white light cystoscopy, according to professor H Barton Grossman, professor Department of Urology at the Maryland. Anderson Cancer Center in Houston, Texas, and the lead investigator of the trial.

Photocure, a Norwegian pharmaceutical company specialising in dermatology and cancer, has received US Food and Drug Administration’s approval for Cysview.

Photocure will now receive a 10 million milestone payment from GE Healthcare, its US licensee, and will be eligible for undisclosed royalties once the product has been launched.

Cysview is already sold in 21 European countries and Korea under the brand name Hexvix by Photocure and its licensee GE Healthcare.

Bladder cancer is the fourth most common type of cancer in men and the eighth most common in women in the US.

More than 70,000 people in the US were diagnosed with cancer of the bladder in 2009, with an estimated 14,000 people dying from the disease, according to the National Cancer Institute.

Bladder cancer is usually very difficult to detect. The most common, initial sign is red-colored urine, which calls for urine cytology and cystoscopy.

Photocure develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications.

Besides Hervix, Photocure has developed a proprietary light source, which is used in combination with the Visonac cream.