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.

Nucleix President and COO OpherShapira. Photo: courtesy
Nucleix President and COO OpherShapira. Photo: courtesy

“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.”

The urine test has been shown to have 90 percent sensitivity, 83% specificity and 97% negative predictive value. “Negative predictive value is especially good for monitoring; if we say there is no cancer, you can trust it,” says Shapira.

The company, based in Rehovot, saw a high level of interest from urologists following its presentation to the American Urology Association in San Diego last May.

That was followed by a $3 million fundraising round led by Aurum Ventures MKI, the tech investments arm of Morris Kahn, and existing shareholder Zohar Zisapel, a well-known Israeli entrepreneur and private investor. Its previous round in 2014 raised $5.5 million mainly from OrbiMed, Zisapel and other private investors. Since Nucleix was founded in 2008, the company has raised a total of about $13 million.

The fresh capital will be used toward clinical trials, as well as to expand the workforce from its current 16 employees and initiate marketing of Bladder EpiCheck, the company’s first product.

Bladder cancer is the fifth most common cancer in the world and the fourth most common cancer among men, with more than 200,000 new patients diagnosed annually. In the United States, 800,000 bladder cancer patients are subjected to a lifelong cycle of testing and monitoring.

“This additional round will further strengthen our ability to execute our plan of becoming a world leader in epigenetics in general and in cancer diagnosis and monitoring specifically,” commented Nucleix chairman and CEO Elon Ganor.

Finding changes in pattern inside cells

Ganor founded Nucleix together with two Weizmann Institute of Science PhDs — Danny Frumkin (VP research) and Adam Wasserstrom (VP development) – with a focus on forensic medicine, but they later shifted to bioinformatics.

Their novel technology to detect areas of DNA changes in cancerous tissue led to the development of proprietary markers and an assay to identify them.

The test “reads” changes in the methylation pattern of DNA against a large background of normal signals coming from healthy cells. Methylation, aprocess that activates or deactivates specific genes, is a powerful tool to distinguish between cell types. Cancer cells are always characterized by changes in methylation pattern.

“We are developing two other applications based on the core technology, for lung and colorectal cancer,” says Shapiro. These will use blood samples.

“As far as we know, ours is the best technology available for detecting changes in liquid biopsies,” he says. “Some companies have colorectal cancer tests using stool or blood, but we believe ours is superior.”

Dan J. Gelvan, managing director for life sciences at Aurum Ventures MKI, said, “We are excited to join this great company and are hopeful that this not only will turn into a great financial success, but also make a sustainable and significant contribution to mankind.”

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