Phased regulation essential for valuation says new European diagnostics group
This article was originally published in Scrip
Diagnostics development needs to have clear regulatory milestones akin to the preclinical, and Phase I, II, and III of drug development, says the coordinator of a new European group of small diagnostics companies launched yesterday (30 September 2010). "Investors backing companies developing biomarker-based diagnostics for personalised medicine need a clearer indication of when the value is created," says Frederic Druck, coordinator of the European Medical Diagnostic Cluster (EMDC). "At present, whether a test is valuable or not depends on a consensus of key opinion leaders – the medical profession users of the product. Diagnostics need a common language so that investors can understand how the value milestones can be created," he says.
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