Genomic Health Announces Oral Presentation of Positive Results from Second Large, Independent Clinical Validation Study of Oncotype DX® in DCIS Breast Cancer at 2014 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS)

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Results from First Clinical Study Using NGS-based Proprietary Liquid Biopsy Platform to Detect Presence of Breast Cancer Also Will Be Presented

REDWOOD CITY, Calif., Sept. 26, 2014 /PRNewswire/ -- Genomic Health, Inc. GHDX today announced that results from a second large, independent clinical validation study of Oncotype DX® in patients with a pre-invasive form of breast cancer known as DCIS (ductal carcinoma in situ) will be featured as an oral presentation at the 37th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), which is being held December 9-13, 2014.

The results of the study, which was conducted by the Ontario DCIS Study Group in Canada, demonstrated that the Oncotype DX DCIS Score predicted the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast.

The oral presentation, (Abstract: S5-04; Rakovitch E et al) titled "A large prospectively-designed study of the DCIS score: Predicting recurrence risk after local excision for ductal carcinoma in situ patients with and without irradiation," will take place on December 12 at 10:15 a.m. Central Time in the Exhibit Hall D of the Henry B. Gonzalez Convention Center.

Results of additional Oncotype DX studies will be presented as follows:

Thursday, December 11

  • Abstract: P3-06-35
    Poster Session 3: "Association of estrogen receptor (ER) levels and prediction of antiproliferative effect of hormone therapy (HT) in lower ER-expressing tumors."
    Authors: Dixon JM, Turnbull A, Renshaw L, Rothney MP, Loman CA, Arthur L, Thomas JS, Young O, Murray J, Williams L, Sing AP, Cameron D.
    Location: Exhibit Halls A-B
    Time: 5-7 p.m. CT

Friday, December 12

  • Abstract: P4-02-08
    Poster Session 4: "Global quantitative measures using next-generation sequencing for breast cancer presence outperform individual tumor markets in plasma."
    Authors: Beasley EM, Abramson RD, Alexander GE, Chan D, Bradley K, Collin F, Crager M, Dei Rossi A, Dorado J, Friedman A, Gibb WJ, Jeong J, Jones C, Ku CJ, Ma Y, Morlan J, Qu K, Rao A, Scott A, Tezcan H. 
    Location: Exhibit Halls A-B
    Time: 7:30- 9 a.m. CT

  • Abstract: P4-11-01
    Poster Session 4: "Prognostic impact of discordance between different risk assessment tools in early breast cancer (Recurrence Score, Central Grade, K167): Early outcome analysis from the prospective phase III WSG-PlanB trial."
    Authors: Nitz U, Gluz O, Kates RE, Hofmann D, Kreipe HH, Christgen M, Shak S, Clemens M, Kraemer S, Aktas B, Kuemmel S, Reimer T, Kusche M, Heyl V, Lorenz-Salehi F, Just M, Liedtke C, Wuerstlein R, Harbeck N.
    Location:  Exhibit Halls A-B
    Time: 7:30- 9 a.m. CT

Saturday, December 13

  • Abstract: P6-08-06
    Poster Session 6: "The Multidisciplinary Application of Genomics in Clinical Practice (MAGIC) survey: Identification of early stage hormone receptor-positive (HR +), HER2-breast cancer (BC) patients for whom multigene assays may be valuable."
    Authors: Aapro M, Bargallo Rocha JE, De Laurentiis M, Elizalde R, Landherr L, Linderholm B, Mamounas T, Markopoulos C, Martin M, Neven P, Petrovsky A, Rea D, Rouzier R, Smit V, Svedman C, Thomssen C.
    Location: Exhibit Hall C
    Time: 7:30- 9 a.m. CT

About Genomic Health
Genomic Health, Inc. 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 screening and surveillance, through diagnosis, treatment selection and monitoring.  Genomic Health's lead 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 and has been shown to predict the likelihood of recurrence in ductal carcinoma in situ (DCIS).  In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multi-gene expression test developed for the assessment of risk of recurrence in patients with stage II and stage III disease, and the Oncotype DX prostate cancer test, which predicts disease aggressiveness in men with low risk disease. As of June 30, 2014, more than 19,000 physicians in over 70 countries had ordered more than 465,000 Oncotype DX tests.  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. To learn more about OncotypeDX tests, visit: www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the attributes and focus of the company's product pipeline; the applicability of clinical study results to actual outcomes; the ability of any potential tests the company may develop to optimize cancer treatment; and the ability of the company to develop and commercialize additional tests in the future. 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 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; our ability to develop and commercialize new tests and expand into new markets domestically and internationally; 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; the company's ability to obtain capital when needed 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 June 30, 2014. 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.

Logo - http://photos.prnewswire.com/prnh/20130425/SF01493LOGO

SOURCE Genomic Health, Inc.

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