Posts Tagged ‘personal genomics’

Consumer Genomic Testing Challenges Physicians to Stay within the Guidelines

April 12th, 2012
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Practice guidelines help physicians and other health care providers deliver consistent and information-based medical advice to their patients. But health care is changing radically: Genomic testing costs dipping below $2,000, patients and consumers accessing information over the web and even ordering tests for themselves, and the general awareness of genetic information in treatment decisions, are all factors at the base of this sea change. These dynamics are leading to greater consumer demand for this personalized genomic information, and possibly to consideration of health care options based on that information.
How do we balance guidelines focused on standardizing physician behavior with individual consumer demands for testing?
A new study at Brigham and Women’s Hospital and the University of Michigan has begun to plumb the depth of this new consumer interest in genomics. The Personal Genomics (PGen) study is one of the first interdisciplinary inquiries to examine why people want genomic testing now. It will survey 1,000 volunteers. Then, physicians, scientists, attorneys, genetic counselors, psychologists and bioethicists – many of whom hope the study will guide public policy and business practices in this area – will analyze the results.
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Tapping Personalized Health Care’s Potential

April 6th, 2011
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“Translating the knowledge we are gaining from gene discoveries into practical clinical and public health applications will be critical for realizing the potential of personalized health care and improving the health of the nation.”
— Muin J. Khoury, M.D., Ph.D., Director, Office of Public Health Genomics, Centers for Disease Control & Prevention
There are several interesting and exciting developments in personalized health that extend well beyond clinical medicine and into areas of science, ethics, government policy and regulation, patient advocacy, and business.   In January of this year, the Ewing Marion Kauffman Foundation published The Personalized Health Project—Identifying the gaps between discovery and application in the life sciences, and proposed solutions. This report provides insights from key thought leaders as to how far we have come, where there are gaps and barriers, and how far away we are from reaching the goal of implementing personalized health care solutions.
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Point/Counterpoint: On FDA Regulation of DTC Genetic Tests

March 10th, 2011
Posted by reporter Emma Hitt wrote yesterday, “A U.S. Food and Drug Administration advisory committee has agreed that direct-to-consumer (DTC) clinical genetic tests should have more oversight from the U.S. Food and Drug Administration (FDA).”
The recommendation came after the FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee met for two days in Washington, DC. The Panel discussed several issues – from potential risks of incorrect results for DTC testing performed without medical counseling to claims associated with various DTC genetic tests.
We’ve long been interested in this subject area and we followed some of the live coverage of the panel via Twitter posts from the likes of @RDGene @aliciaault @likesky3 @genomicslawyer and @dgmacarthur using the hashtag #FDADTC. Subsequently, we read perspectives surrounding the Panel’s deliberations via blog posts by @dnalawyer and @dgmacarthur, which you may want to check out.
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After the Conference Ends: Thoughts Following Tri-Con 2011

March 3rd, 2011
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Now that the Molecular Med Tri-Con 2011 has ended and attendees are back at their offices, labs, practices, and/or hospitals – or perhaps have landed at their next business meeting or conference destination – it’s a good time to reflect on some of my general observations from the event.
The conference covered so much information that it would be impossible to review every topic. Following are a few areas that captured my attention and remain in my thoughts:


  • STEM CELLS – There was a lot of focus on induced pluripotent stem cells (iPSC), in particular how to better characterize and understand those cells. Pluripotent stem cells can differentiate, or change, to become any one of the many types of cells that make up an organism. These cells are already being used for applications such as drug testing and drug screening. Once they are induced to re-differentiate, iPSC can provide good models for disease: what some conference speakers referred to as a “disease in a dish.” Some discussion among presenters focused on the idea of isolating cells from patients, producing iPSC, and then reintroducing the produced cells into the patient to replace cells that have been damaged or lost as a result of disease – an elegant form of cell-based therapy. Although widespread use of this approach is likely a ways off, I’m both optimistic of the therapeutic potential and somewhat cautious because of regulatory hurdles and potential safety issues (including some data showing tumor production in animals). Read the rest of this entry »

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Adding DNA to the ABCs of Med School

February 3rd, 2011
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Last week, GenomeWeb News reported (free subscription required for full access) that a multi-disciplinary team from Tufts University had “urged gradual and calculated incorporation of genomic material into medical school training programs” after the team had looked at potential consequences of introducing genomics-related training into the curriculum at Tufts University School of Medicine.
According to the GenomeWeb article, several medical school faculty members were voluntarily genotyped using 23andMe tests. Medical students then analyzed the collected information. Based on a year’s plus analysis and implementation of the program, the researchers called for inclusion of personal genomics-related training and information within medical schools.
The lead study author wrote, “We strongly advocate that genomic analysis and personalized medicine is a necessity for modern medical school education… Our experiences illustrate that adding this material to a medical school curriculum is a complex process that deserves careful thought and broad discussion within the academic community.”
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