The biggest shift I have seen in the past 12 months is indeed the level of coverage midkine is getting. The MK antibody work may require a number of years to complete BUT it could have a huge impact IMHO when used as an adjunct with mainstream treatments for chemo resistant tumours.
Nearer term we have MK Elisa. My understanding is that CE approval is required to distribute into Europe as the test falls within the definition of "medical devices".
" 3. Medical Devices A "Medical Device" is defined in Directive (93/42/EEC) as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of : o diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap. o investigation, replacement or modification of the anatomy or of a physiological process. o control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means. more >>"
I also rough understanding that it is the responsibility of the importer to be assurred that the manufacturer has completed a required quality assurance assessment and has an appropriate quality monitoring and exception reporting process in place. SO basically as soon as a quality audit of AsureQuality?s fully accredited facility in Melbourne can be completed for this product line, imports into Europe could (conceivably) commence. I note that accredited Australian quality processes are accepted in Europe.
I'm not an expert on any of this and I'm not willing to pay for some of the guidelines (DYOR) but the link is here: http://www.ce-marking.org/
cheers
CDY Price at posting:
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