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...
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. The analysis concludes that a large...
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