June 27, 2013
As the field of molecular diagnostics advances and new companies offering genomic-based
breast cancer tests emerge, a number of you have approached us with questions about how
these efforts compare to Oncotype DX®
and our work at Genomic Health. We’d like to take this
opportunity to highlight the important distinctions that should be taken into consideration as you
evaluate these companies and their products.
The Oncotype DX Recurrence Score®
was developed to answer the specific question of which
estrogen receptor positive (ER+) breast cancer patients need chemotherapy in addition to
hormonal therapy. To validate it for this specific purpose, Genomic Health and its collaborators
obtained practice-changing results from landmark clinical studies that included patients
randomized to treatment (so that both prognosis and prediction could be obtained) and followed
for long term outcomes. To date, it is the only test validated to predict who benefits from
chemotherapy, and the only test included in all major breast cancer guidelines (ASCO,NCCN)
for treatment decision making. As a result, it has been broadly adopted by the physician
community, widely reimbursed in the United States, and used to guide treatment in more than
350,000 breast cancer patients around the world.
Additionally, recent data presented at major medical meetings showed clinically meaningful
differences between patient results generated by the Oncotype DX breast cancer test and the
Mammaprint test, which unlike Oncotype DX was developed using a largely untreated patient
population that did not reflect the established standard of care of hormone therapy for patients
with estrogen receptor positive disease. Specifically, these results revealed that patients
stratified as high-risk by Mammaprint with high ER expression may lead physicians to
inappropriately offer treatment with chemotherapy.
We realize there is a lot of information in the market right now that can lead to confusion, and
we encourage you to ask the following questions when talking to companies who claim to offer
tests similar to Oncotype DX.
• What specific clinical question was the test developed to answer and is it relevant
to current practice?
• Were multiple randomized studies, including treated and untreated patients,
conducted to validate and reproduce the test’s ability to answer this question?
• What comprises test volume – is it commercial or research use?
• Are they getting paid routinely by private payors without appeal?
• For tests in kit form, like the one Nanostring is developing, what measures are
taken to ensure high, reproducible quality at local labs?
• Have they conducted prospectively designed, randomized trials with long term
clinical outcomes (i.e., 10 years or longer)?
• What is the pipeline opportunity and how is the company investing in it to drive
We would be happy to schedule a call to discuss this information in more detail.
Chief Operating Officer