Medical Device Link.

Final Thoughts

With more focus on the increasing cost of healthcare, the potential of companion diagnostics continues to grow in importance. Diagnostic tests that determine an individual’s therapeutic responsiveness save scarce healthcare dollars and give patients better choices.

The year 1999 could be heralded as the official start of the personalized medicine movement, with several articles published on the topic in the popular media that year. However, even after a decade, there are few examples of personalized medicine in clinical use today. The most successful are the Her2/neu protein and the Trastuzumab antibody, and the BCR-ABL protein and the drug Imatinib (Gleevec).

The need for diagnostics to aid in drug discovery is not disputed. Challenges arise in balancing the complexity of new technology and the timing of diagnostic validation and broad-scale deployment during the drug development cycle. Being able to distinguish when a biomarker warrants corporate investment to produce a clinically useful companion diagnostic versus a more limited, research-use-only application is critically important yet difficult.

That the IVD industry is moving to embrace companion diagnostics can be seen in the past and future estimated market growth. The molecular diagnostics market is currently estimated at $3.8 billion of the $32 billion total IVD market. Molecular diagnostics are projected to have an annual growth rate of more than 17% in the next several years.

One of the best opportunities for companion diagnostics to prove significant value is where there is a convergence of high cost of therapy, a significant side-effect risk, and a life-saving therapeutic decision that must be made. Medco’s 2008 DrugTrend report stated that specialty drug spending has been the single largest contributor to overall increases in drug costs. Disproportionally contributing to this increased drug spending are cancer therapeutics, which experienced a 15% increase versus a 2% increase in Medco’s overall prescription drug spending. This cost increase, coupled with potentially debilitating drug side effects, make a compelling case for companion diagnostics in cancer therapeutics.

With unmet medical needs, positive market trends, cost drivers, interested policymakers, and available government money, many IVD companies are investing in personalized medicine. For example, DxS recently announced a collaboration with Exosome Diagnostics to focus on blood-based measurements of KRAS, EGFR, BRAF, and variants in other related genes utilizing discoveries in circulating nanovesicles made by researchers. There are many other examples of established and start-up diagnostic companies focusing resources to innovate and take advantage of the opportunities in companion diagnostics.

Drug companies also understand personalized medicine’s business and market importance. For example, AstraZeneca’s drug Iressa is used to treat non-small-cell lung cancer. Researchers noted that patients benefitting from Iressa therapy had variants within the EGFR gene mutations. Identifying the subset of patients that can benefit from treatment enables clinicians to prescribe Iressa for individuals who are appropriate candidates for the drug and avoid costly ineffective treatment of unqualified patients. This provides AstraZeneca with an excellent patient benefit and a new revenue opportunity.

Another model of personalized medicine can be seen in CLIA-approved laboratories benefiting from offering new tests that guide treatment decisions. Innovative cancer diagnostic applications in the form of laboratory-developed tests (LDT) are how Myriad Genetics, Genomic Health, and others have built their markets. With the growing success and visibility of LDTs, many debates have been sparked, and the regulatory landscape is becoming uncertain.

The IVD industry, through AdvaMed, is proposing risk-based regulation of IVDs that, regardless of the origin of the test, would triage the level of regulation under FDA’s jurisdiction as opposed to CLIA’s. Changes that increase the burden of regulation could have a negative impact on innovation and investment, thereby affecting current market acceleration that has resulted from the potential of comparative effectiveness research stimulus money and growing public awareness.

The ability to develop a diagnostic that will predict the efficacy of a drug requires successfully putting all the pieces together in an increasingly complex and uncertain environment. This challenge will continue. Whatever name it may go by—personalized medicine, tailored therapies, companion diagnostics, or theranostics—the time is right to show the profound difference it can make on the healthcare system and positive patient outcomes.

Tiffany P. Olson is a consultant and director on several diagnostic company boards and the former president and CEO of Roche Diagnostics Corp. She can be reached at olson_tiffany@msn.com.