Excellent news indeed. With approval they can concentrate on completing licensing and sales deals which I would anticipate they have already had pre approval discussions with several parties.
The assay approval is a big one. This will open up the diagnostic labs that don’t typically have a mass spec but do have all the assay lab equipment and are the large providers of assay testing in hospital and to the GP’s/Specialist in large high throughput labs. Assays also being typically much cheaper the likelihood of take up in somewhere like the USA with the user pays system should find it much easier to get rolling being more wallet friendly. For doctors easier to add to a single request slip, for example if you are diabetic the doctor wants some blood tests they can just add the Promarker test to the slip and all sorted, easy. Also being cheaper countries like Australia much greater chance to have such a test covered by Medicare, small price to pay to save big money long term makes good sense (but governments are not good at seeing that kind of benefit )
Look forward to the push into the US and rest of world in fact now European approval is done. Many other countries will accept the CE with little further testing, just the typical overly complicated and lengthy paper approval and local expert review process..haha.
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Ann: CE Mark for Proteomics' PromarkerD Immunoassay Kit, page-4
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