Tag Archives: healthcare innovation

Was the FDA Right to Shut Down 23andMe’s Marketing?

My opinion: the FDA was right to act in November by asking 23andMe to stop marketing  its personal genome service.  Now, don’t get me wrong, I have been rooting for 23andMe to succeed at what they are doing in the … Continue reading

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FDA Tells 23andMe to Stop Marketing: Death Knell for DTC Genomics 1.0?

The FDA on Friday published a letter  addressed to 23andMe’s CEO, Anne Wojcicki, telling the company to cease marketing it’s Saliva Collection Kit and Personal Genome Service (PGS). In the letter, Alberto Gutierrez, Director of the Office of In vitro … Continue reading

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Where are we with Targeted Cancer Therapeutics?

In a recent project, I received a draft manuscript discussing targeted cancer therapeutics and companion diagnostics in which the writer made this statement: ”CML patients in treatment with Gleevec now have the same life expectancy as people without the disease, … Continue reading

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Gene Patents No More

As most of you know at this point, on Jun 13, 2013 the Supreme Court of the United States ruled essentially that native DNA sequences are not patentable subject matter.  The question ended up with the Supreme Court precisely because … Continue reading

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DTC Genomics Update

I have fallen a bit behind in posts about the DTC genomics field.  One change in my posts to note with respect to this subject, I am going to start using the term “personal genomics” to describe the field, since … Continue reading

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Lessons learned from tumor heterogeneity

My recent blog post, Tumor heterogeneity, revealed…, discussed the New England Journal of Medicine article by Gerlinger and colleagues describing the genetic heterogeneity found both within a patient’s individual tumor nodules and between spatially separate nodules.  There has been a … Continue reading

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An Academic—Industry Partnership to Study DTC Genomics

A GenomeWeb story today provides details of a study being performed by researchers at Brigham and Women’s Hospital and the University of Michigan on the motivations for getting and effects of DTC genomic testing. The study will look at the … Continue reading

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DTC Genomic Testing—What’s it good for anyways?

What is the fuss over DTC genomic/genetic testing all about anyways?  DNA is just a sequence of letters, isn’t it?  Lots of people are experiencing angst over the fact that these upstart companies would have the nerve to sequence part … Continue reading

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Are most published research findings false?

Many people are aware of the work of John Ioannidis regarding the analysis of research findings and the conclusions drawn from those analyses.  In particular, these concepts were described by him in a paper published in PLOS Medicine in 2005 … Continue reading

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Genomic Test for your Kid’s Sports Ability? Oh, Please!

The US FDA just sent out more letters to genomic testing firms asking them to explain why their testing kits should not be regulated.  The companies in question (and their target market) were Lumigenix (disease predisposition), American International Biotechnology Services … Continue reading

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