11 Feb 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Cellmid has signed an important option agreement with listed Japanese company Fujikura Kasei, 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.
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. Cellmid has already licensed its patents for the early diagnosis, prognosis and disease monitoring of lung cancer (Celera-Quest) and bladder cancer (Pacific Edge Biotechnology). This latest agreement further validates the company's midkine diagnostic technology.