What New Her2 Tests Say about Personalized Medicine
This article was originally published in Start Up
Traditional diagnostic tests for Her2 (the target of the drug Herceptin) have well-documented failings. In July, Monogram Biosciences launched a new Her2 test, and two months later, Genomic Health added Her2 status information to its breast cancer test. They believe that more comprehensive, multianalyte tests may better guide therapy and yield a pharmacoeconomic benefit, even at eight to 10 times the cost. These developments point to the need for a more nuanced approach to the management of cancer as a chronic disease and a more nuanced view of personalized medicine.
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Qiagen has bought up DxS, a private UK-based provider of molecular tests including one for the mutant oncogene KRAS. Like the June 2009 deal by Labcorp. for Monogram Biosciences, it shows how IVD companies with very different business models are moving towards a common ground in personalized medicine and disease management.
For most diagnostics companies, the prospect of premium pricing has been an elusive dream. The health care landscape is peppered with expensive novel drugs priced to underscore their clinical impact on patient care. A similar strategy for pricing novel diagnostics with significant clinical impact makes sense, especially since many of them are driving the decisions to deploy novel drugs in the first place. Now, strong system economics arguments are becoming more mainstream and payors are beginning to reward companies with reimbursement of their premium priced tests, based upon rigorous clinical arguments supporting the diagnostics' benefits to clinical decision-making and compelling economic arguments customized to each major payer.
Since the initial approval of Herceptin ten years ago, it has become the poster child for personalized medicine. But for almost as long as the drug has been on the market there have been questions about the diagnostics used with the drug and the degree to which they correlate with clinical response. Spurred by testing guidelines in 2007, there's a new-found focus on the nitty-gritty of laboratory conduct and test concordance that could serve as a useful model for addressing the broad issues of drug-diagnostic convergence.