Posts Tagged ‘genetics’



Diversigen, Baylor Miraca Form Partnership

February 26th, 2016
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clinical_studies

The recent partnership between Diversigen and Baylor Miraca Genetics highlights the importance of both human genetics and the microbiome in drug development and ultimately in clinical decision making.

We are in the early days of understanding the scope of the impact of the microbiome but we already know of powerful associations in diseases as diverse as inflammatory bowel disease, diabetes and cancer.

We are excited about this partnership as it leverages real technical and interpretive expertise across across a broad array of genomes relevant to human health.

Read more about their partnership.

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Negative Headlines, Scientific Vulnerability and the Future of Genetic Tests

July 19th, 2011
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Though the life sciences industry is making great progress with genetic tests and targeted therapies, a recent article in the New York Times (“How Bright Promise in Cancer Testing Fell Apart”) exposes disturbing and cautionary insights into the application of this technology. The article revealed that research on the application of complex genetic tests to match cancer patients to the best available therapy may not be as promising as it seems.
 
The article describes a situation that emerged just over a year ago that raised serious doubts about a test developed by researchers at Duke University. The test used gene expression signatures to characterize tumors and to identify those most likely to respond to different drugs.
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Assessing the Evidence for Genomics

June 2nd, 2011
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Genomic research is accelerating at a rapid pace and improvements in technology are fueling these advances (as has previously been addressed within the Popper and Co. blog). We’re now entering a phase of evaluating how to incorporate translated genomic information into clinical testing. With this comes a critical need to verify how and when to use a test, how these tests can modify clinical care, and how this process translates into improved outcomes for patients.
 
In April, Margaret Piper, Ph.D., M.P.H., presented at the Personalized Medicine Partnerships Conference outside of Washington, DC.  Dr. Piper is director, genomic resources, at the Technology Evaluation Center of the Blue Cross and Blue Shield (BCBS) Association. Her presentation, “Assessing the Evidence for Genomics: Focus on the Patient,” centered on the impact of genomics on administrative processes and the adoption of new technologies into clinical care. As Dr. Piper noted, “We’re generating a lot of information that relates genomics to disease, but we’re only just starting to gather information on how to translate this into treatments and medical decision making.”
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Point/Counterpoint: On FDA Regulation of DTC Genetic Tests

March 10th, 2011
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Medscape.com 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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