Genomic Health Announces Presentation of Eight Oncotype DX® Studies at the 2015 CTRC-AACR San Antonio Breast Cancer Symposium

New "Big Data" SEER Study Establishes Oncotype DX as the Only Multi-gene Breast Cancer Test with Prospective Outcomes Data in Tens of Thousands of Patients!

Genomic Health, Inc. 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:

1) 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.

2) 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.

3) 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.

4) 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.

5) 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.

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