Genomic Health: Launching a Paradigm Shift ... and an Innovative New Test

By Robert Chess, Lyn Denend, Stefanos Zenios
2006 | Case No. OIT49

In late October 2003, Randy Scott and the Genomic Health team had just received the results of Genomic Health’s first pivotal trial. The company’s product, Oncotype DX, a first-of-its-kind genomic assay that quantified the likelihood of breast cancer recurrence, had exceeded the standard measures of patient age, tumor size, and tumor grade in predicting recurrence outcomes. The results of the study would be presented at the 2003 San Antonio Breast Cancer Symposium in December and published in the New England Journal of Medicine in December of 2004. Scott and his team now faced the challenge of determining how and when to launch this groundbreaking product. Convinced of the benefits of (and need for) Oncotype DX, the team was eager to get to product to market as quickly as possible. Having spent nearly $30 million on research, development, and validation over more than three years (and anticipating that it might take as long as 18 to 24 months for the company to gain consistent reimbursement for the product), Scott also felt some urgency to get to market. However, as a result of extensive market research performed earlier in the year, Genomic Health realized it had less than 10 percent awareness in the physician community, and even less among consumers. When asked about what factors would influence their adoption, physicians overwhelmingly cited clinical validation studies-and lots of them-as being most important. While the result of the first pivotal trial were impressive, it was unlikely that a lone study would be persuasive to the many skeptics within the oncology field who felt that the legitimate use of genomics in making treatment decisions was still 10 to 20 years in the future. Furthermore, while initial market feedback had indicated adequate interest in a test that accurately predicted recurrence, physicians were increasingly telling the Genomic Health team that they wanted more information, including data that predicted how patients would respond to chemotherapy. While Oncotype DX was capable of producing this kind of data, this variable had not been included in the initial study so no clinical data was available to support this claim. Finally, while Genomic Health had been working on the reimbursement issue for the last six months, it still lacked firm commitments from any payers to reimburse Oncotype DX. This case explores the decisions the Genomic Health team had to make in defining the marketing plan, pricing, and reimbursement strategies that would give it the greatest chance of success in brining its new product to market.

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