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Top PGx Reporter Stories of 2012 Highlight Increasing Challenges of Personalized Medicine Market


In 2012, PGx Reporter readers were most interested in stories that reflected the growing complexity of the personalized medicine market.

PGx Reporter's most read stories last year discussed incentives affecting adoption of molecular technologies; tracked the emerging regulatory framework for drug/test combination products; chronicled the changing landscape for gene patents; and followed how life sciences companies are changing their business strategies to focus more on developing products for individualized care.

For example, readers favored stories that highlighted the lessons learned from the approval of two personalized medicine products, Roche's Zelboraf and Pfizer's Xalkori. Similarly, Qiagen's experience taking its KRAS companion test for Erbitux through regulatory approval also ranked in the top 10.

However, even after garnering FDA approval for companion tests, diagnostic developers are still facing adoption challenges. This was a hot topic in 2012, particularly given Roche's experience with some hospitals that balked at having to switch from their standard Sanger sequencing-based lab tests for gauging BRAF mutations to Roche's FDA-approved companion test kit for Zelboraf. Both Roche, developer of the PCR-based Cobas test, and Quest, which offers Sanger sequencing-based lab testing, compared the two platforms' ability to gauge BRAF mutations in melanoma patients and came to somewhat divergent conclusions about which test is better.

Stories exploring the business strategy at Roche, fast becoming the premier personalized medicine-focused pharma company in the industry, were well read. Company officials have said that 60 percent of its pharma pipeline products are being developed with a companion diagnostic.

However, the most read story in 2012 was how a key sector of the healthcare industry, pharmacy-benefit managers, were reigning in their involvement in personalized medicine. After personalized medicine proponent Medco was acquired by Express Scripts, many of the leaders supporting PGx research studies left the company, and according to industry insiders, Express Scripts has no plans to conduct clinical utility research on molecular diagnostics at the level Medco was pursing. Following this, competing PBM CVS Caremark also scaled back some of its personalized medicine programs.

While most in the life sciences industry speak of molecularly targeted medicines as the future of healthcare, the popularity of that story underscores that personalized medicine is still very much an emerging field, and some sectors are still waiting to see where the chips falls.

1. Following Merger, Express Scripts May Cut Back Medco's Personalized Medicine Programs

2. FDA Official Says Personalized Medicine Regulation Taking Shape Following Zelboraf, Xalkori Success

3. Personalized Medicine in 2011: Some Successes, Slow Progress, Continued Economic Woes

4. Quest Study Finds Sanger-based BRAF Mutation Test More Sensitive than Roche's Cobas Test

5. Qiagen's Experience Developing KRAS CDx for Erbitux Yields Lessons for Rx/Dx Development

6. During Investor Day, Roche Highlights Personalized Medicine as Key Area for Future Growth

7. Invalidation of Prometheus Patents Stands to Impact Dx Industry, but Effect on Gene Patents Unknown

8. Pfizer Using Qiagen KRAS Test to Study Dacomitinib Head-to-Head Against Tarceva in NSCLC

9. Ventana's Growing Companion Dx Focus Mirrors Parent Roche's Investment in Personalized Rx

10. Pfizer, Roche Officials Share Lessons Learned from Rx/Dx Co-development of Xalkori and Zelboraf