Completed GMP Manufacture of Midkine Test
Cellmid Limited has completed technology transfer in relation to its midkine blood test (MK ELISA) and the test kits have been successfully produced in a GMP compliant environment in AsureQuality’s fully accredited facility in Melbourne.
Transitioning from a development phase to fully GMP compliant manufacture is an important milestone towards being able to produce commercial quantities of the MK ELISA. In addition, it is a substantial step in Cellmid’s application for regulatory approval (CE marking) of the kit.
The MK ELISA was originally developed by Cellmid in collaboration with BioGenes in Germany. The test is a highly accurate method for determining midkine levels in blood (serum) of individuals with a detection limit of 8 pg/mL (pg/mL = parts per trillion).
The MK ELISA is highly accurate in quantifying serum midkine concentrations between 25 and 1000 pg/mL (dynamic range). This is very important as most healthy adults have around 300pg/mL serum midkine levels or less.
With the current dynamic range Cellmid’s MK ELISA may be used to differentiate between healthy individuals and patients who suffer from cancer.
The commercially produced GMP compliant MK ELISA will be used to complete testing in Cellmid’s current in-house diagnostic programs, including CK3000 (testing of healthy individuals), CS5000 (testing of cancer patients) and CAN104 (veterinary cancer diagnostic program). In addition, it will be made available to collaboration partners and licensees.