Completed GMP Manufacture of Midkine Test
Tuesday, August 02, 2011
• GMP production of MK ELISA completed
• Equivalent performance achieved
• Important milestone in CE marking
Sydney, Australia, 2 August 2011
Cellmid Limited (ASX: CDY) 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.
Cellmid Limited (ASX: CDY)
Cellmid is an Australian biotechnology company developing innovative novel therapies and diagnostic tests for inflammatory diseases, heart attack and cancer. Cellmid holds the largest and most comprehensive portfolio of intellectual property related to midkine and midkine antagonists globally. The Company’s most advanced clinical development program is for the treatment of acute myocardial infarction (AMI) utilising the midkine protein. Cellmid is also developing anti-midkine antibodies for the treatment of inflammatory and autoimmune disorders. In addition, Cellmid is commercialising midkine as a biomarker for cancer diagnosis. Elevated midkine concentration in the blood and other body fluids is strongly indicative of cancer. Cellmid’s first product, the MK-ELISA, is a blood test that sensitively and accurately measures serum midkine levels.
Midkine is a multifunctional growth factor that is highly expressed during embryonic development. Midkine modulates many important biological interactions such as cell growth, cell migration and cellular adherence. These functions are relevant to cancer, inflammation, autoimmunity, ischemia, nerve growth/repair and wound healing. Midkine is barely detectable in healthy adults and only occurs as a consequence of the pathogenesis of a number of different disorders. Midkine expression is often evident very early in disease onset, even before any apparent physical symptoms. Accordingly, midkine is an important early marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only present in a disease context, targeting midkine does not harm normal healthy tissues.
AsureQuality is a commercial company 100% owned by the New Zealand government. From modern, purpose-built GMP facilities in Melbourne, Australia AsureQuality contract manufactures diagnostic kits and reagents to each customer’s specification. AsureQuality’s clients include one of the world's largest veterinary diagnostic companies, based in Switzerland. In addition, AsureQuality has partnered with many companies in the Australian biotechnology industry.
Maria Halasz, CEO
T +612 9299 0311
CELLMID LIMITED ACN 111 304 119 ASX I CDY
Level 6, 40 King Street, Sydney NSW 2000 AUSTRALIA
TELEPHONE +61 2 9299 0311 FACSIMILE +61 2 9299 2198
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