REDWOOD CITY, Calif.,
Nov. 16, 2015 /PRNewswire/ -- Genomic
Health, Inc. (Nasdaq: GHDX) today announced that the company will
present results from eight Oncotype DX® breast cancer
test studies at the 38th CTRC-AACR San Antonio Breast
Cancer Symposium (SABCS), taking place December 8-12, 2015 at the Henry B. Gonzalez
Convention Center. Presentations in invasive breast cancer,
ductal carcinoma in situ (DCIS) and next-generation sequencing
(NGS) include:
- Prospective outcomes results from a large population
observational study based on the NCI-funded Surveillance,
Epidemiology, and End Results (SEER) registry. The analysis
provides important new insights into long-term outcomes in more
than 38,000 breast cancer patients treated prospectively with
Oncotype DX Recurrence Score® results at diagnosis.
- Single gene analysis from the Trial Assigning
IndividuaLized Options for Treatment
(Rx), or TAILORx, one of the largest-ever adjuvant breast
cancer treatment trials, which was designed and conducted by the
ECOG-ACRIN Cancer Research Group under the sponsorship of the
National Cancer Institute. The first TAILORx results were
recently published in The New England Journal of Medicine.
The new analysis includes additional single gene results from
patients with Recurrence Scores less than 11 who received hormonal
therapy alone.
- Prospective clinical outcomes results from a large,
multi-center patient cohort from Clalit Health Services, the
largest Health Maintenance Organization in Israel, where Oncotype DX was used to identify
patients for treatment with hormonal therapy alone or with hormonal
therapy plus chemotherapy.
- A multi-center decision impact analysis evaluating the clinical
utility of the Oncotype DX DCIS Score™ in driving radiation
treatment recommendations by surgeons and radiation oncologists
across 13 sites in the United
States, providing a second independent study of the value of
individualized risk estimates in personalizing treatment planning
for patients with DCIS.
- Two studies, including an oral presentation, showcase Genomic
Health's leadership in using Next Generation Sequencing and
bioinformatics tools to produce and analyze "big data" in gene
discovery.
Following are details for each presentation (all times are in
Central Standard Time):
Thursday, December 10
- Abstract: P2-07-01
Poster Session 2: "Association of TILs with clinical
parameters, recurrence score, and prognosis in patients with early
HER2-negative breast cancer (BC) – A translational analysis of the
prospective WSG planB trial"
Authors: Liedtke C, Gluz O, Heinisch F, Feuerhake F, Kreipe
HH, Clemens M, Nuding B, Kraemer S, Reimer T, Svedman C, Shak S,
Nitz U, Kates RE, Harbeck N, Christgen M.
Location: Exhibit Halls A-B
Time: 7:30 - 9 a.m.
- Abstract: P2-08-01
Poster Session 2: "Prospective trial of endocrine therapy
alone in patients with estrogen receptor positive, HER2-negative,
node-negative breast cancer: Results of the TAILORx low risk
registry"
Authors: Sparano JA, Gray RJ, Makower DF, Pritchard KI,
Albain KS, Hayes DF, Geyer Jr CE, Dees EC, Perez EA, Olson Jr JA,
Zujweski J, Keane MM, Gomez Moreno HL, Reddi RP, Goggins TF, Mayer
IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Atkins JN, Berenberg
JL, Sledge Jr GW.
Location: Exhibit Halls A-B
Time: 7:30 - 9 a.m.
- Abstract: S3-02
Oral Presentation in General Session 3: "Molecular
predictors of outcome on adjuvant CAF plus tamoxifen (T) vs T in
postmenopausal patients (pts) with ER+, node+ breast cancer –
transcriptome expression analysis of the phase III trial
SWOG-8814"
Authors: Albain KS, Crager MR, Barlow WE, Baehner FL, Bergamaschi A, Rae JM,
Ravdin PM, Tripathy D, Gralow JR, Livingston RB, Osborne CK, Ingle
JN, Pritchard KI, Davidson NE, Carey LA, Cherbavaz DB, Sing AP,
Shak S, Hortobagyi GN, Hayes DF.
Location: Exhibit Hall D
Time: 9:45 a.m.
Friday, December 11
- Abstract: P5-17-03
Poster Session 5: "The 12-gene DCIS Score assay: Impact on
radiation treatment (XRT) recommendations utility"
Authors: Manders JB, Kuerer HM, Smith BD, McCluskey C,
Farrar WB, Frazier TG, Li L, Leonard CE, Carter DL, Chawla S,
Medeiros LE, Guenther JM, Castellini LE, Buchholz DJ, Mamounas EP,
Wapnir IL, Horst KC, Chagpar A, Evans SB, Riker AI, Vali FS, Solin
LJ, Jablon L, Recht A, Sharma R, Lu R, Sing AP, Hwang ES, White
J.
Location: Exhibit Halls A-B
Time: 5 - 7 p.m.
- Abstract: P5-13-03
Poster Session 5: "Fulvestrant plus anastrozole as
neoadjuvant therapy in postmenopausal women with hormone receptor
positive early breast cancer"
Authors: Khan QJ, Barr JA, Britt AS, Kimler BF, Connor CS,
McGinness M, Mammen JMV, Wagner JL, Amin A, Springer M, Baccaray S,
Fabian CJ, Sing AP, Sharma P.
Location: Exhibit Halls A-B
Time: 5 - 7 p.m.
- Abstract: P5-07-01
Poster Session 5: "Successful whole transcriptome analysis
of 25-year-old breast tumor samples from the phase III trial
SWOG-8814 by next generation sequencing (NGS): Standardized
analytical methods for exploratory and validation studies"
Authors: Cherbavaz DB, Hayes DF, Qu K, Crager MR, Barlow WR,
Goddard AD, Beasley EM, Jeong J, Collin F, Liu M-L, Rae JM, Ravdin
PM, Tripathy D, Gralow JR, Livingston RB, Osborne CK, Ingle JN,
Pritchard KI, Davidson NE, Carey LA, Sing AP, Baehner FL,
Hortobagyi GN, Shak S, Albain KS.
Location: Exhibit Halls A-B
Time: 5 - 7 p.m.
- Abstract: P5-08-02
Poster Session 5: "Real-life analysis evaluating 1594
N0/Nmic breast cancer patients for whom treatment decisions
incorporated the 21-gene Recurrence Score result"
Authors: Stemmer SM, Steiner M, Rizel S, Soussan-Gutman L,
Geffen DB, Nisenbaum B, Ben-Baruch N, Isaacs K, Fried G,
Rosengarten O, Uziely B, Svedman C, Rothney M, Klang SH, Ryvo L,
Kaufman B, Evron E, Zidan J, Shak S, Liebermann N.
Location: Exhibit Halls A-B
Time: 5 - 7 p.m.
- Abstract: P5-15-01
Poster Session 5: "Breast Cancer Specific Survival in 38,568
Patients with Node Negative Hormone Receptor Positive Invasive
Breast Cancer and Oncotype DX Recurrence Score Results in the SEER
Database"
Authors: Shak S, Petkov VI, Miller DP, Howlader N, Gliner N,
Howe W, Schussler N, Cronin K, Baehner FL, Penberthy L.
Location: Exhibit Halls A-B
Time: 5 - 7 p.m.
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
company's flagship product, the Oncotype DX breast cancer test, has
been shown to predict the likelihood of chemotherapy benefit as
well as recurrence in invasive breast cancer. Additionally, the
test predicts the likelihood of recurrence in a pre-invasive form
of breast cancer called DCIS. With half a million patients tested
in more than 90 countries, the Oncotype DX tests have redefined
personalized medicine by making genomics a critical part of cancer
diagnosis and treatment. To learn more about Oncotype DX breast
cancer tests, visit: www.OncotypeDX.com or
www.mybreastcancertreatment.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 international
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 quarter ended September 30, 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 marks are the property of their respective
owners.
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SOURCE Genomic Health, Inc.