Genomic Health, Inc.
301 Penobscot Drive
Redwood City, CA 94063
January 15, 2008
Dear Health Care Provider,
We at Genomic Health are pleased to inform you that the Oncotype DX Breast Cancer Assay is now
included in the 2008 NCCN Clinical Practice Guidelines in Oncology Breast Cancer. NCCN, an alliance
of 21 world-leading cancer centers dedicated to improving the quality and effectiveness of care
provided to patients with cancer, annually updates their comprehensive clinical practice guidelines for
treatment recommendations relying on evidence based consensus.
The NCCN expert panel announced at the 2007 San Antonio Breast Cancer Symposium the inclusion
of the Oncotype DX Breast Cancer Assay in their updated guidelines which were published online in
early 2008 at http://www.nccn.org. The NCCN Guidelines state:
“[T]he Panel considers the 21-gene RT-PCR assay as an option when evaluating patients with
primary tumors characterized as 0.6-1.0 cm with unfavorable features or >1cm, and node-
negative, hormone receptor-positive and HER2-negative. In this circumstance, the recurrence
score may be determined to assist in estimating likelihood of recurrence and benefit from
The Panel summarized that the data supporting this conclusion were based on the analysis of the
NSABP B-14 and B-20 trials. According to the Panel,
"[T]his assay system was able to quantify risk of recurrence as a continuous variable . . . and
to predict responsiveness to both tamoxifen and CMF or methotrexate/5-fluorouracil/leucovorin
chemotherapy." [The] Oncotype DX recurrence score may provide additional prognostic and
predictive information beyond anatomic staging and determination of ER/PR and HER2
The Oncotype DX Breast Cancer Assay is the only multi-gene expression assay included in the current
ASCO and NCCN breast cancer guidelines recommendations. These recommendations support the
use of Oncotype DX as an appropriate and powerful tool for use as part of breast cancer management.
These recommendations also differentiate Oncotype DX from other multi-gene expression assays,
which are not included in the guidelines recommendations. We look forward to continuing to offer you
and your patients the important information provided by the Oncotype DX Breast Cancer Assay.
Gary Palmer, MD MPH MBA
Vice President, Medical Affairs
Genomic Health, Inc.
NCCN Clinical Practice Guidelines in Oncology™ Breast Cancer. v.2.2008 (“NCCN Guidelines”)
http://www.nccn.org/professionals/physician_gls/PDF/breast.pdf (accessed January 9, 2008).
NCCN Guidelines at MS-15. The NCCN Guidelines Categories of Evidence and Consensus for this
recommendation is Category 2B.
Id. (citing Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated,
node-negative breast cancer. N Engl J Med. 2004; 351:2817-2826 and Paik S, Tang G, Shak S, et al.
Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive
breast cancer. J Clin Oncol. 2006;24:3726-3734.
NCCN Guidelines at MS-16.