Israeli startup Nucleix Ltd., a cancer detection screening company, has developed a urine test that it says can detect with high levels of accuracy the recurrence of bladder cancer in patients.
The company’s diagnostic kit studies a patient’s urine for changes in the DNA of the cells that could signal the repeated onset of cancer. “Ours is a noninvasive, very sensitive and cost effective liquid biopsy test,” said Dr. Opher Shapira, the CEO of Nucleix, in a phone interview.
A European study compared the company’s Bladder EpiCheck product to the procedures currently used to check recurrence of bladder cancer, and found that in 99.3% of cases when the test results were negative, the patients were indeed free of high-grade cancer. High-grade cancer cells tend to grow and spread more quickly than low-grade ones, and usually have a worse prognosis and need more a more aggressive treatment.
The results of the study were published in the European Urology Oncology journal. The single-arm, prospective, double-blind clinical study was performed in five leading urology centers in Europe on 440 patients who were recruited in their first year of followup.
“The results of the test mean that physicians who prescribe our urine test for patients and get a no-cancer result back from the lab can be assured their patients do not have high grade tumors,” said Shapira.
The results of the study give the company “full clearance” to market its product in the European market, he said. The urine test got the European CE Mark of approval last year and was launched by the firm in the European Association of Urology in Copenhagen in March. To date the product has been sold to hospitals and private labs in Italy, Spain and the Czech Republic. The test has also gotten the nod from Israeli regulators and Nucleix started marketing the product in Israel, Shapira said.
Bladder cancer, which ranks fifth among the most frequently diagnosed cancers in the EU, has a high disease recurrence rate — some 70% — requiring frequent followups. The standard followup procedure includes a cystoscopy, a procedure in which a tube with a camera is inserted through the opening of the urethra into the urinary bladder to visually inspect for the presence of cancer. This procedure is coupled with an urine analysis to inspect for cancerous cells and, if needed, a biopsy of the suspect area.
Bladder cancer is one of the most expensive cancers to treat on a per patient basis because of the high recurrence rate, costing the EU approximately €5 billion per year.
“With bladder cancer the problem is not early detection,” said Shapira, “since it usually has signs like blood in the urine. The main problem is monitoring for recurrence of the cancer, because it is a highly recurrent disease. The standard procedures for monitoring cause repeated discomfort in patients and are very costly to the health system.”
The firm has already started a clinical trial in the US seeking FDA approval for marketing the product in the US, he said.
The technology was developed by the founders of Nucleix, Dr. Adam Wasserstrom and Dr. Danny Frumkin, both PhDs in genetics from the Weizmann Institute of Science.
The Rehovot-based firm is also currently working on the final stages of the development of a blood test for the early detection of lung cancer, using the same genetic screening system.
“Lung cancer is a deadly cancer that is almost always detected too late. Early detection noninvasive tools are highly needed in the market,” Shapira said.
The firm hopes to start large- scale clinical trials of the product in Europe, the US and China soon.