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Top 10 Most-Read 'PGx Reporter' Stories of 2009: ACLU/Myriad Suit, BRCA Testing, DTC Genomics, FDA Relabeling Figure Big

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By Turna Ray 

In May 2009, the American Civil Liberties Union challenged the constitutionality of gene patenting in the US in an ambitious case that took on the exclusive licensee of BRCA gene patents Myriad Genetics, patent holder University of Utah Research Foundation, and the US Patent and Trademark Office. The story, analyzing the ACLU's claim that the plaintiff's patents are not only illegal but also violate the US Constitution by restricting the free flow of information, was the most widely read story on Pharmacogenomics Reporter last year.

Myriad's exclusive licensing practices for patents covering numerous BRCA mutations associated with increased risk for developing hereditary breast and ovarian cancer has long been a lightening rod for controversy in the life sciences industry. As such, stories on Myriad or BRCA mutations were popular among readers in 2009, including an article on the direct-to-consumer genomics firm 23andMe's offering of BRCA testing and another article featuring Myriad's advice to doctors about genetic counseling associated with its BRACAnalysis test.

In general, DTC genomics firms such as 23andMe and Navigenics sparked controversy and garnered readers' interest as players in the nascent industry attempted to make their offerings more affordable while struggling to keep afloat in a tough economic climate; faced ethical questions about inking collaborations with physicians groups in the face of questionable clinical utility of gene risk data; and tried to align clinical standards and iron out distinct rules with state health regulators. Articles exploring these issues and the value of personal gene risk data ranked in the top 10 most-read stories of last year.

In terms of federal regulation, last year the US Food and Drug Administration made headlines by updating the labels of several high-profile drugs with gene-response data, most notably for the anti-platelet agent Plavix and for the class of EGFR-inhibiting monoclonal antibody colorectal cancer drugs, including Vectibix and Erbitux. However, as the FDA has repeatedly noted, its task of updating drug labels is often challenged by imperfect data.

Thus, any update by the agency to drug labels with pharmacogenomics data usually raised a flurry of questions. As such, stories on the impact of FDA's protracted labeling update for Vectibix and Erbitux on drug makers and FDA's lack of dosing recommendations for Plavix generated a high volume of reads.

Finally, in 2009, big pharma ramped up collaborations with small and large diagnostics shops to develop companion tests for their drugs. The increase in Rx/Dx collaborations, thought to be the linchpin of PGx-guided medicine, had some industry observers proclaiming the death of the blockbuster model. But one article in the top 10, analyzing the confluence of events leading up to recent Rx/Dx collaboration deals, suggests that such proclamations may be premature as big pharma still hopes for the blockbuster home run.


1.Myriad's BRCA Patents Not Only Illegal, but Also Unconstitutional, ACLU Lawsuit Alleges

2.23andMe Adds BRCA Breast/Ovarian Cancer Testing to Service

3.Lack of FDA Guidance on KRAS Testing Creates Confusion; Pharmas See Lower Sales

4.Myriad Avoids Genetic Counseling 'Bottleneck' For BRCA Testing By Helping Docs Do It Themselves

5.Navigenics Launches Cheaper Annual Genomic Service; Will Doctors Bite?

6.Mass General Hospital to Genetically Test All Cancer Patients within One Year

7.FDA Updates Plavix Label with PGx Data, but Does Not Provide Dosing Recommendations

8.Conference Discussion Questions Big Pharma's True Motivations for Pursuing Personalized Medicine

9.DxS Submitting PMA Application for Class III TheraScreen KRAS Assay

10.Study Suggests Validity of Personal Genetic-Risk Data May Be Inflated

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