Singapore-based diagnostic firm BioCheetah has entered into an exclusive licensing and commercialisation agreement with Nippon Kayaku for VECanDx ELISA, a bladder cancer diagnostic assay kit, in Japan.
Developed by BioCheetah, VECanDx ELISA is a proprietary non-invasive, urinary biomarkers-based urine test for individuals with haematuria or a history of bladder cancer.
The kit, based on the Enzyme-Linked Immunosorbent Assay (ELISA), quantifies the levels of protein expression of five new biomarkers using proprietary detection antibodies.
The presence or absence of bladder cancer is then determined by analysing the readings using proprietary software to create a single risk score.
Under the partnership, BioCheetah will give Japan-based Nippon Kayaku the exclusive rights to develop and market the assay kit in Japan.
BioCheetah will continue to finish clinical trials in Singapore, France, and China, while Nippon Kayaku will handle clinical trials, regulatory applications, product distribution, and sales in Japan.
The Japanese firm will pay BioCheetah milestones and an upfront fee after the deal is signed and the product is commercialised in Japan.
Cystoscopy is currently the gold standard in bladder cancer diagnosis. It is said to be an invasive diagnostic procedure that needs anaesthesia and comes with several side effects.
BioCheetah, a diagnostic company, plans to fill this unmet diagnostic gap by offering non-invasive diagnostic tests that are specific and sensitive for the detection of bladder cancer.
The firm has developed a line of new biomarkers and detection antibodies for diagnostic usage.
Its VECanDx ELISA test is presently available as a lab-developed test (LDT). It is anticipated to be launched soon as in vitro diagnostic (IVD) for clinical applications.
BioCheetah said its other pipeline products consist of point-of-care test (POCT) kits. The company also operates an ISO13485 pilot manufacturing site in Singapore.
