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Posts From the monthly archives: "July 2014"

The Personalized Medicine Coalition (PMC) has released the results of a public opinion survey, and it is clear that more needs to be done to inform the average U.S. citizen about personalized medicine’s benefits. Only 40% of respondents had heard the term “personalized medicine,” and only 11% had discussed personalized medicine options with…(Read More)

Continuing our series of interesting biomarkers to watch in various therapeutic areas we now present 10 biomarkers to watch in the Metabolic and Endocrinology (ME) therapeutic area (see previous posts for Oncology and Cardiovascular). These biomarkers were selected using the same approach as for the prior lists, whereby the only bias applied to the list…(Read More)

Genetic Engineering News just published a report describing personalized medicine’s progress, and it includes the results of a survey of “hundreds of respondents derived from a broad geographic swath … and broad affiliations.” A key finding from this survey is that personalized medicine is being driven primarily by improvements in drug development, namely speed of…(Read More)

Target Selection: The Universal Challenge A never-ending challenge for companies that develop IVDs, LDTs, and RUO products is identifying the most marketable biomarkers, both to guide sales and marketing strategies for existing products, and to guide investment in the development of new products. Biomarkers being used in clinical trials provide some of the best…(Read More)

Five U.S. Senators have signed a letter urging the Office of Management and Budget (OMB) to released a draft guidance on LDT regulation. OMB apparently has 90 days to review regulatory policies but has held the FDA’s draft guidance on LDTs “for several years.” While FDA has hinted in the past that it…(Read More)