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Top 10 PGx Reporter Stories in 2010: Scientific, Business, and Legislative Issues Loom Large


Originally published Jan. 3.

While 2010 produced a number of high-profile news stories in the personalized medicine space — such as Myriad's ongoing efforts to defend its gene patents and direct-to-consumer genomics firms' tribulations with the US Food and Drug Administration and Congress — the stories that captured the most interest among PGx Reporter's readership delved into the complex scientific challenges, business strategies, and legislative issues impacting the field of pharmacogenomics.

The most-read story in PGx Reporter in 2010 explored whether the market introduction of a new anticoagulant, Pradaxa, would relegate pharmacogenetic testing to dose warfarin to the history books before the strategy even sees a chance for adoption. Comparing the cost of genetic testing for a generic drug versus a brand-name treatment, pharmacogenomics experts honed in on the specific subpopulations of patients that might still benefit from PGx-guided warfarin dosing.

Another list topper was a PGx Reporter exclusive analyzing a legislative proposal under consideration by Republication Utah Senator Orrin Hatch that would recognize diagnostics as being distinct from other medical devices. The bill, which is still in the drafting process, would create a Center for Advanced Diagnostics Evaluation and Research responsible for ensuring the safety and efficacy of a new category of tests called "advanced personalized diagnostics," comprising both test kits and laboratory-developed tests.

And as the healthcare reform debate dominated Capitol Hill for the large part of the year, a report on how personalized medicine fit into the emerging healthcare paradigm was also well read.

Although readers were inundated with coverage of the FDA's sudden regulatory action against DTC genomics firms over the summer, they still paid close attention when the agency discussed regulatory strategies for drug/diagnostic combination products, or when it updated labeling for drugs such as Plavix and warfarin to inform patients and doctors of how genetic abnormalities can impact response to these treatments.

Furthermore, stories on the strategies of pharmacogenomics players — ranging from the investment of large pharma to the innovation of small diagnostic companies, adoption by doctors, and insurers' willingness to pay for health interventions based on emerging science — continued to capture readers' attention in 2010.

Coverage of Perlegen's struggles to keep afloat and another report on the pharma behemoth Pfizer's PGx strategy in oncology ranked among the best read stories of the year. And finally, readers were interested in an article exploring how pharmacy-benefit manager Medco is advancing new business models and driving personalized medicine adoption by departing from big pharma's traditional partnership strategy and linking with small diagnostic companies.

Top Ten PGx Stories in 2011:

1. When Might Warfarin PGx Be Better Than Pradaxa? Stakeholders Weigh In

2. FDA Issues Boxed Warning for CYP2C19-Linked Poor Metabolism of Plavix

3. Oncotype DX Study Underscores Challenges for Patients, Doctors in Interpreting Genomic Test Results

4. Draft Bill Proposes FDA Create New Division to Review 'Advanced Personalized Diagnostics'

5. Perlegen Defunct: PGx Firm Shutters Doors After R&D Disappointments, Mounting Losses

6. FDA Updates Warfarin Labeling with PGx-Guided Dosing Ranges

7. FDA Official Offers Advice on Regulatory Path for Companion Diagnostics

8. Personalized Medicine Poised to Become Part of US Healthcare Reform Plan

9. With Medco Around for Dx Shops Developing PGx Tests Independently, Who Needs Pharma?

10. Focusing on Personalized Medicine, Pfizer Reports PGx Data for Several Oncologics at ASCO

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.