15 Years From Discovery To The Clinic

The total number of novel biomarkers that have come to market in new IVD tests cleared or approved by the FDA over the last 12 years has been very low; an average of just 3 per year*. Is this cause for alarm? At first glance one would assume yes, but the next factor to understand is how long it ...

Documentation of Clinical Validation Inconsistently Provided by LDT Developers

by John Audette | Mar 18, 2015 | Marketing, LDT Regulation, News

A study described in a recent paper in the Journal of the National Cancer Institute analyzed the marketing of laboratory-developed tests (LDTs) for cancer by 55 different companies, academic institutions and other organizations.




Pharmacovigilance and Safety Biomarkers

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