Israeli firm BioLight Life Sciences Investments has received CE Mark approval for its non-invasive test, CellDetect, which is used for detecting bladder cancer in urine.
With the CE Mark, now BioLight will be able to sell the product across Europe and other territories.
According to BioLight, its CellDetect technology is capable of accurate diagnosis of cancerous and precancerous cells based on the combination of color and morphology, and the technology is capable of finding out cancerous cells in urine samples of patients with a history of the disease.
BioLight CEO Suzana Nahum Zilberberg said: "This CE Mark approval for the CellDetect bladder cancer test represents an important commercial milestone.
"Of the estimated 430,000 new cases of bladder cancer occurring worldwide in 2012, approximately 151,000, or 35%, were in Europe according to Cancer Research UK.
"There is a clear and urgent need for improved diagnostics in this important market, and we believe the CellDetect® technology answers that call, as well as the potential for diagnosing additional cancer indications."
BioLight has also received patent related to the core of the CellDetect technology from the European Patent Office. The validity of the patent will expire in March 2027.
The company’s cancer diagnostics subsidiary Micromedic Technologies has been given the responsibility to develop CellDetect technology.