Emergence of Companion Diagnostics

As personalized medicine becomes a reality, more drugs will be marketed with a diagnostic test (companion diagnostics), which means a patient's treatment will be guided by his or her own genetic information. Currently, there are approximately 37 products that facilitate personalized treatment, mostly in cancer, and approximately 10 percent of labels approved by the FDA now contain pharmacogenomic information. In fact, studies of a gene called KRAS have recently resulted in the makers of Erbitux (Lilly/Imclone) and Vectibix (Amgen) requesting that the FDA limit the use of these drugs in colorectal cancer patients with a mutation of the KRAS gene because the drugs do not work for this population.

The emergence of companion diagnostics has opened the door to new marketing channels. One example of pharmaceutical marketing in the diagnostic space is the appearance of print advertising for therapeutic agents in the College of American Pathologists' official publication. Pathologists, molecular pathologists, and heads of molecular diagnostic laboratories will be new marketing targets for gene-based therapies. It is important that you familiarize yourselves with the media that can be used to reach companion diagnostics decision-making audiences.

Personalized medicine has the potential to replace traditional trial-and-error medicine. Marketers will need to be fluent in marketing companion drugs and diagnostic tests, including laboratory-developed tests, analyte-specific reagents (ASRs), and IVDMIAs (in vitro diagnostic multivariate index assays) such as the multi-gene, multi-pathway gene expression test (XDx AlloMap), which can be used to assist physicians in managing heart transplant patients for potential organ rejection. Clinical laboratory diagnostic testing will become as important as the drug entity as it identifies suitable patients for treatment. Will we soon hear the phrase "blockbuster diagnostic"?

Comparative effectiveness research, recently funded at $1.1 billion under the US government stimulus bill, will seek to identify which treatment protocols provide the best patient outcomes. Based on the role some diagnostic tests have played in identifying populations that would benefit from a particular drug, we may see diagnostic medicine—both laboratory- and imaging-based—gain as much importance as the drug itself, especially if the tenets of personalized medicine can be incorporated into this legislation.

What does this all mean for marketers? Just as new therapeutics will be much more specific in terms of intended patient subpopulations, equally targeted will be communications that speak to the therapeutic/diagnostic decision maker. Pharmaceutical and diagnostic companies will be able to contribute even more fully to informed decision-making, and not simply interact with physicians. Third party payers will need to be educated on new—and potentially more costly—treatments. Quality rather than quantity will be rewarded.

Simply put, medical marketers, regardless of past experience, will need to break out of their silos and greet the bright new day of personalized medicine.

Frequently Asked Questions

Who are the in vitro diagnostic test leaders today?

Roche, Siemens, Johnson & Johnson. Bayer has dropped from fourth to seventh.

Where will the next diagnostic breakthroughs originate?

Probably not from the large IVD players who are accustomed to developing assays for high throughput of high volumes of tests.

Where do I look for a companion diagnostic partner?

Look for companies with proprietary technologies; for example, Asuragen and its expertise in miRNA; or OncotypeDX testing from Genomic Health, whose IVDMIA test predicts recurrence of breast cancer.

What's the profile of the ideal companion diagnostic?

It is a molecular diagnostics test performed at the point-of-care, using a buccal swab, immersed in a room-temperature, ready-to-use amplification reagent that provides a definitive colorimetric endpoint, read by any operator as "yes" or "no," with sensitivity and precision at 100 percent and unquestioned clinical utility. This immediately triages the patient, who is protected by GIST legislation, to a dispensing unit for a one-time treatment.

Kathleen Dunn is president of KFDunn Life Sciences, a division of Aloysius Butler & Clark, and a member of the Personalized Medicine Coalition. She can be reached at kdunn@a-b-c.com