bladder cc-by-Ed Uthman,   flickr

The Israeli company Nucleix has developed a simple, inexpensive urine test to monitor bladder cancer, which has the highest lifetime treatment cost per patient of all types of cancer.

Bladder EpiCheck is expected to be available in Europe in the third quarter of 2016, says Nucleix President and Chief Operating Officer Opher Shapira. Right now, the product is undergoing advanced clinical trials in the Netherlands, Germany, Spain and Israel.

“We expect to earn the CE mark this summer, and probably next year we will start clinical trials in the US and then apply for FDA approval, ” he tells ISRAEL21c.

Shapiro explains that because bladder cancer has a high rate of recurrence, patients must be monitored invasively every few months after initial treatment. Nucleix therefore saw a market need for a noninvasive “liquid biopsy” assay using body fluids rather than body tissues.

“A urine test is very simple and painless, and if there is a tumor there are many markers present in the urine, ” says Shapira. “We had wonderful results in our own tests on 200 patients, and to get regulatory clearance we have to replicate those results on hundreds of patients.”