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Posts From the monthly archives: "August 2014"

The number of publications that describe novel biomarkers for cancer has grown by an average of 24% over the last 5 years. As previously reported, this growth rate is essentially the same as for novel biomarkers across all diseases. This isn’t surprising since 26% of the nearly 4,000 clinical biomarkers listed in BiomarkerBase…(Read More)

There has been a significant surge in the number of new biomarkers described in the literature during 2014. Between 2008 and 2013, the annual growth rate in publications that describe new biomarkers was 25% per year. When looking at the average number of publications per day this year versus last year, the growth rate has…(Read More)

In response to congressional pressure, FDA has released a copy of its long-awaited draft guidance covering regulation of LDTs. FDA seems to have addressed many if not all of the concerns regarding negative impacts from LDT regulation, at least in writing the guidance. Actual implementation will be interesting to watch, but several things about…(Read More)