HUGE UPSIDE, IMO.CE (Conformité Européenne) Markregistration for PromarkerD (MS) as an IVD medicaldevice (in vitro diagnostic) indicates that it meets the essential requirementsof all the applicable European regulations and allows for its sale throughoutthe European Union(EU). The registration is for the mass spectrometry versionof the test, PromarkerD (MS), and lays the groundwork for future CE marking ofPromarkerD on other technology platforms such as the recently validatedPromarkerD immunoassay [ASX: 17 September]
The CE Mark registration follows the launchof PromarkerD in Spain, where diabetes affects 10 per cent of the adultpopulation or 3.6 million people [ASX: 13 September]. The PromarkerD (MS) testwas launched in September in partnership with clinical diagnostics provider Atturos(Ireland) [ASX: 12 September] and under an exclusive two-year licence agreementwith Patia Europe for the region of Spain
The World Health Organisation estimates theEuropean Region is home to 60 million adults with diabetes, and currentlyapproximately 1 in 3 have chronic kidney disease. PromarkerD could aid clinicaldecision-making by identifying at-risk individuals for earlier therapeuticintervention and help to minimise the effect of the disease.
ALSO, in 2020, results coming:
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