Cellmid Limited has signed an important option agreement with listed Japanese company Fujikura Kasei Co Ltd (Fujikura), a major supplier of latex particles used in medical diagnostics.
Under the terms of the Option to License agreement Cellmid will supply its proprietary anti-midkine diagnostic antibodies for validation on Fujikura’s latex platform. Cellmid will receive an initial fee and a further payment should Fujikura elect to exercise its license option. Cellmid will also receive royalties on any future midkine diagnostic products sold by Fujikura.
The license agreement will proceed on condition that Fujikura is able to reach a limit of detection (LOD) of 500 picogram/mL midkine in serum on its proprietary latex diagnostic platform. Cellmid’s highly sensitive MK-ELISA detects midkine to a limit of 8 picogram/mL, and Fujikura is planning to achieve a LOD close to that level on its latex platform using the same antibody pair.
Healthy individuals usually have serum midkine levels below 500 picogram/mL. A latex based test with a 500 picogram/mL LOD means that the test will be able to identify individuals with elevated midkine levels, which may lead to the development of a number of cancer diagnostic products. Fujikura has regulatory and product development programmes in place to accelerate this path to market.
A latex based assay will be highly beneficial for the commercial launch of any midkine diagnostic product, as it is widely used and accepted in pathology laboratories. It is also preferred as it can easily be automated, reducing processing costs.
“We are very excited about this opportunity as the midkine diagnostic platform lends itself to multiple, high value product development opportunities,” said Fujikura’s Head of Medical Project Division, Dr Hideyuki Kuroda.
Cellmid CEO Maria Halasz said she was confident the partner company’s expertise in latex based diagnostics would ensure success in achieving the required LOD for a midkine test.
“Fujikura is the ideal partner for us as they have a strong focus on building their medical diagnostic business and consider midkine an important part of this commercial expansion,” she said.
Midkine has been extensively validated as an early marker for a range of cancers and has also been shown to be useful in prognosis and disease management.