BioCheetah has signed an exclusive licensing and commercialisation agreement with Nippon Kayaku for the development and marketing of a new bladder cancer diagnostic assay kit in Japan.

Blood in the urine (haematuria) is a symptom of bladder cancer, the tenth most common cancer globally.

As part of the agreement, Nippon Kayaku will receive exclusive rights from BioCheetah to develop and market the urinary biomarkers-based VECanDx enzyme-linked immunosorbent assay (ELISA) kit in the country.

BioCheetah will proceed with clinical trials in France, Singapore and China while Nippon Kayaku will handle trials, regulatory applications, and product distribution and sales in Japan.

Nippon Kayaku will make upfront and milestone payments to BioCheetah following the agreement signing and product commercialisation in Japan.

Named VECanDx ELISA, the non-invasive urine test is developed by BioCheetah for adults experiencing haematuria or with a previous history of bladder cancer.

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It is designed to measure the protein expression levels of five new biomarkers using detection antibodies.

Software is later used to analyse the measurements to generate a single risk score, indicating the presence or absence of bladder cancer.

Cystoscopy is the existing gold standard for diagnosing bladder cancer. It is an invasive diagnostic procedure that requires anaesthesia and may have several side effects.

BioCheetah aims to address the diagnostic gap in bladder cancer by offering specific and non-invasive diagnostic tests.

BioCheetah, a Singapore-based A*STAR/IMCB spin-off diagnostic company, is focused on the development of new biomarkers and detection antibodies for applications in diagnostics.

Japan-based Nippon Kayaku is expanding its focus on generic anti-cancer drugs, biosimilar products and medical devices to ensure the ongoing delivery of necessary pharmaceuticals, devices and diagnostic drugs.