REDWOOD CITY, Calif.,
June 1, 2015 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today announced results
from multiple Oncotype DX® studies presented at the 2015 American
Society of Clinical Oncology (ASCO) Annual Meeting. The
presentations reinforce the robustness of the Oncotype DX tests
across invasive breast cancer, ductal carcinoma in situ (DCIS) and
prostate cancer, which, to date, have helped guide treatment
decisions for more than half a million patients worldwide.
Two DCIS Studies Reinforce Independent Value of Oncotype
DX DCIS Score™
A secondary analysis from the second large validation study
conducted by the Sunnybrook Health Sciences Centre in Ontario evaluated the DCIS Score™ result as a
predictor of local recurrence in 718 patients treated with
breast-conserving surgery (BCS) alone with any surgical margin
width. The analysis showed that, in all patients regardless of
margin status, the DCIS Score result was significantly associated
with the 10-year risk of local recurrence (p<0.001). These
results underscore the value of the DCIS Score result in providing
unique tumor biology information that is not readily apparent by
margin status alone.
A separate secondary analysis evaluated the correlation between
the DCIS Score result and clinicopathologic features, such as age,
tumor size, nuclear grade and multifocality. The results from 571
women with DCIS who had BCS alone and clear margins showed that the
DCIS Score result quantifies risk of local recurrence independent
of clinicopathologic features, reconfirming previous findings from
the ECOG-ACRIN Cancer Research Group clinical validation study.
"To accurately assess a patient's individual risk for cancer
returning, we now have a tool like Oncotype DX that can provide
important biological information beyond the traditional measures
that had been available to physicians before," said Michael Alvarado, M.D., breast cancer surgeon,
the University of California, San
Francisco Helen Diller Family Comprehensive Cancer
Center. "Multiple studies and my own personal experience with
this test clearly demonstrate that Oncotype DX provides important
information about the risk of local recurrence based on the biology
of the tumor beyond what is apparent by traditional measures such
as age, size, or grade."
Baseline Characteristics from NCI-Sponsored Trial
Assigning IndividuaLized Options for Treatment (Rx), or TAILORx,
Confirmed Consistency of Oncotype DX Recurrence Score® Results
Across Race and Ethnicity
An analysis of the study population enrolled in the TAILORx
trial examined baseline patient characteristics, including race,
ethnicity and body mass index (BMI), as well as their Recurrence
Score results. The results showed no significant difference in
Recurrence Score result distribution among Caucasian,
African-American, Hispanic or Asian patients despite the clinical
differences between those groups of patients. These data are
consistent with prior studies that have shown that the Recurrence
Score result provides information beyond that provided by clinical
and pathologic features.
Coordinated by the ECOG-ACRIN Cancer Research Group, TAILORx is
designed to evaluate the effect of chemotherapy in women with
mid-range Recurrence Score results, as previous studies have
confirmed chemotherapy benefit for those with high Recurrence Score
disease and minimal, if any, benefit for patients who have low
Recurrence Score disease. TAILORx is one of the largest breast
cancer adjuvant treatment trials, with more than 10,000 patients
enrolled from 1,500 sites in the United
States, Canada,
Ireland, Peru and Australia. Investigator reporting of the
TAILORx long-term outcome results for patients in the mid-range
group is anticipated in 2016-2017.
Study of Oncotype DX Genomic Prostate Score Underscores
Value of Analyzing Gene Groups in Prostate Cancer
In prostate cancer, a study of 3,500 patient tumor samples
processed in Genomic Health's commercial laboratory highlighted the
importance of utilizing multiple biological pathways to predict
tumor behavior. In this study, each of the four gene groups
incorporated in the Oncotype DX Genomic Prostate Score (GPS) showed
large variations in expression and meaningfully affected the GPS
results, underscoring the importance of analyzing distinct genes
across multiple pathways to provide more accurate risk assessment
than currently available clinical risk factors and help improve
treatment decision making.
"These scientific presentations reinforce the Company's
successful approach to understanding risk assessment and, more
importantly, emphasize our commitment to enabling physicians to
individualize treatment plans for their patients," said
Phil Febbo, M.D., chief medical
officer, Genomic Health. "The data we presented at ASCO further
demonstrate the clinical actionability that our Oncotype DX tests
provide, allowing physicians and their patients to make more
informed cancer treatment decisions."
About Oncotype DX®
The Oncotype DX® portfolio of
breast, colon and prostate cancer tests applies advanced genomic
science to reveal the unique biology of a tumor in order to
optimize cancer treatment decisions. The Oncotype DX prostate
cancer test identifies which clinically low risk patients are
eligible for active surveillance, as well as those who may
benefit from immediate treatment by predicting disease
aggressiveness. With half a million patients tested in more
than 80 countries, the Oncotype DX testing has redefined
personalized medicine by making genomics a critical part of cancer
diagnosis and treatment. To learn more about the Oncotype DX
prostate cancer test,
visit: www.OncotypeDX.com or www.myprostatecancertreatment.org.
About Genomic Health
Genomic Health, Inc. (NASDAQ:
GHDX) is the world's leading provider of genomic-based diagnostic
tests that address both the overtreatment and optimal treatment of
early-stage cancer, one of the greatest issues in healthcare today.
The company is applying its world-class scientific and commercial
expertise and infrastructure to lead the translation of massive
amounts of genomic data into clinically-actionable results for
treatment planning throughout the cancer patient's journey, from
diagnosis to treatment selection and monitoring. The company
is based in Redwood City, California, with
European headquarters in Geneva, Switzerland. For more
information, please visit, www.GenomicHealth.com and
follow the company on
Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating to the benefits of the test to
physicians, patients and payors. Forward-looking statements are
subject to risks and uncertainties that could cause actual results
to differ materially, and reported results should not be considered
as an indication of future performance. These risks and
uncertainties include, but are not limited to: the ability of test
results to change treatment decisions; the risks and uncertainties
associated with the regulation of the company's tests; the results
of clinical studies; the applicability of clinical study results to
actual outcomes; the risk that the company may not obtain or
maintain sufficient levels of reimbursement, domestically or
abroad, for its existing tests and any future tests it may develop;
the risks of competition; unanticipated costs or delays in research
and development efforts; and the other risks set forth in the
company's filings with the Securities and Exchange Commission,
including the risks set forth in the company's quarterly report on
Form 10-Q for the year ended March 31, 2015. These
forward-looking statements speak only as of the date
hereof. Genomic Health disclaims any obligation to update
these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype
DX, Recurrence Score, and DCIS Score are trademarks or registered
trademarks of Genomic Health, Inc. All other trademarks
and service
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SOURCE Genomic Health, Inc.