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Breast cancer genomic assays:
facts you need to know
Featuring: The Oncotype DX Breast Cancer Assay, proven to be both
predictive and prognostic of adjuvant chemotherapy benefit
®
ER-positive, Node-positive, Node-negative
Guidelines
Economic Utility
Clinical Utility
Consensus on analytic and clinical
Cost neutral/saving, cost-effective,
Impacts treatment
validity and clinical and economic utility
better resource utilization
decision making
Clinical Validity
Analytic Validity
Outcome
Reproducible
endpoints
and repeatable
Oncotype DX®
Breast Cancer
Assay
70-Gene
Assay
BCI
EPClin
PAM50 ROR
The Oncotype DX Breast Cancer Assay meets all the established
criteria accepted by the scientific and medical community.1,2
®
Only the Oncotype DX Breast Cancer Assay 3-7
is included in all major guidelines
®
Oncotype DX Breast Cancer Assay
®
Prognosis and Prediction of Adjuvant Therapy Benefit
ESMO
NCCN
St. Gallen
ASCO
®
NICE
®
70-Gene Assay
Prognosis only
ESMO
St. Gallen
BCI
Prognosis only
None
EPClin
The Oncotype DX Breast Cancer Assay is included
®
Prognosis only
None
PAM50 ROR
Prognosis only
in all major clinical guidelines due to its demonstrated
ability to be both prognostic and predictive of adjuvant
chemotherapy benefit and its impact on treatment decisions.
None
The Oncotype DX Breast Cancer Assay
is unmatched for its quantity and
quality of clinical evidence
®
With its demonstrated clinical utility, only the Oncotype DX
assay has been validated in 6 separate studies and is both
prognostic and predictive of adjuvant therapy benefit.
clinical evidence and
utility studies with over
patients
9,000
8,9,10
ER-positive, Node-positive, Node-negative
The Oncotype DX Breast Cancer Assay
is second to none
®
The Oncotype DX Breast Cancer Assay
demonstrates cost-effectiveness and
positive health economic impact in
over 20 studies from around the world.9
®
$
covered by
The Oncotype DX Breast Cancer Assay
is covered by many major insurance
plans, and 100% covered by Medicare.
®
95%
of private insurance
companies in the U.S.11
Over a 10-year track record
testing for invasive breast cancer
and 3-year track record for DCIS
+
500,000
*
patients tested
using the Oncotype DX assays
worldwide
12
*majority of patients tested
for invasive breast cancer
Learn more about the Oncotype DX Breast
Cancer Assay at breast-cancer.oncotypedx.com
®
1. Simon. J Natl Cancer Inst. 2009. 2. Hayes. Sci Transl Med. 2013. 3. NCCN Breast cancer guidelines. V1. 2015.
4. Harris et al. J Clin Oncol. 2007. 5. NICE Diagnostics Guidance 10. 2013. 6. Senkus et al. Ann Oncol. 2013.
7. Goldhirsch et al. Ann Oncol. 2013. 8. Levine et al. ASCO 2014. 9. Burke et al. EBCC 2014. 10. Vacirca et al. ASCO
2013. 11. Genomic Health® data on file; image is for illustration only. 12. Genomic Health® data on file.
NCCN and NCCN Guidelines are trademarks of the National Comprehensive Cancer Network. ASCO is a trademark of
the American Society of Clinical Oncology. NCCN and ASCO do not endorse any therapy or product.
Genomic Health and Oncotype DX are registered trademarks of Genomic Health, Inc.
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