Publications & Guidelines

Clinical Validation

Our tests have been clinically validated, peer reviewed and included in major medical guidelines, proving the significance of our science for physicians and patients.

 

Breast Cancer

A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer.
S Paik, S Shak, G Tang, C Kim, J Baker, M Cronin, FL Baehner, MG Walker, D Watson, T Park, W Hiller, ER Fisher, DL Wickerham, J Bryant, N Wolmark
N Engl J Med. 2004 Dec 30;351(27):2817-26.

Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer.
S Paik, G Tang, S Shak, C Kim, J Baker, W Kim, M Cronin, FL Baehner, D Watson, J Bryant, JP Costantino, C Geyer Jr., DL Wickerham, N Wolmark
J Clin Oncol. 2006 Aug 10;24(23):3726-34.

A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients. 
LA Habel, S Shak, M Jacobs, A Capra, C Alexander, M Pho, J Baker, MG Walker, D Watson, J Hackett, N Blick, D Greenberg, L Fehrenbacher, B Langholz, CP Quesenberry
Breast Cancer Res. 2006;8(3):R25.

Clinical significance of the 21-gene signature (Oncotype DX) in hormone receptor-positive early stage primary breast cancer in the Japanese population.
Toi M, Iwata H, Yamanaka T, Masuda N, Ohno S, Nakamura S, Nakayama T, Kashiwaba M, Kamigaki S, Kuroi K; Japan Breast Cancer Research Group-Translational Research Group.
Cancer. 2010 Jul 1;116(13):3112-8.

Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study.
Dowsett M, Cuzick J, Wale C, Forbes J, Mallon EA, Salter J, Quinn E, Dunbier A, Baum M, Buzdar A, Howell A, Bugarini R, Baehner FL, Shak S.
J Clin Oncol. 2010 Apr 10;28(11):1829-34.

Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, estrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomized trial.
Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, Ravdin P, Bugarini R, Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI, Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, Hayes DF; Breast Cancer Intergroup of North America.
Lancet Oncol. 2010 Jan;11(1):55-65.

A multigene expression assay to predict local recurrence risk for ductal carcinoma in situ of the breast.
Solin LJ, Gray R, Baehner FL, Butler SM, Hughes LL, Yoshizawa C, Cherbavaz DB, Shak S, Page DL, Sledge GW Jr, Davidson NE, Ingle JN, Perez EA, Wood WC, Sparano JA, Badve S.
J Natl Cancer Inst. 2013 May 15;105(10):701-10.

A population-based validation study of the DCIS Score predicting recurrence risk in individuals treated by breast-conserving surgery alone.
Rakovitch E, Nofech-Mozes S, Hanna W, Baehner FL, Saskin R, Butler SM, Tuck A, Sengupta S, Elavathil L, Jani PA, Bonin M, Chang MC, Robertson SJ, Slodkowska E, Fong C, Anderson JM, Jamshidian F, Miller DP, Cherbavaz DB, Shak S, Paszat L.
Breast Cancer Res Treat. 2015 Jul;152(2):389-98.

Multigene Expression Assay and Benefit of Radiotherapy After Breast Conservation in Ductal Carcinoma in Situ.
Rakovitch E, Nofech-Mozes S, Hanna W, Sutradhar R, Baehner FL, Miller DP, Fong C, Gu S, Tuck A, Sengupta S, Elavathil L, Jani PA, Bonin M, Chang MC, Slodkowska E, Anderson JM, Cherbavaz DB, Shak S, Paszat L.
J Natl Cancer Inst. 2017 Jan 29;109(4): djw256.

 

Colon Cancer

12-Gene Recurrence Score Assay Stratifies the Recurrence Risk in Stage II/III Colon Cancer with Surgery Alone: The SUNRISE Study
Yamanaka T, Oki E, Yamazaki K, Yamaguchi K, Muro K, Uetake H, Sato T, Nishina T, Ikeda M, Kato T, Kanazawa A, Kusumoto T, Chao C, Lopatin M, Krishnakumar J, Bailey H, Akagi K, Ochiai A, Ohtsu A, Ohashi Y, Yoshino T
J Clin Oncol; 2016

Validation of the 12-gene colon cancer recurrence score in NSABP C-07 as a predictor of recurrence in patients with stage II and III colon cancer treated with fluorouracil and leucovorin (FU/LV) and FU/LV plus oxaliplatin.
Yothers G, O'Connell MJ, Lee M, Lopatin M, Clark-Langone KM, Millward C, Paik S, Sharif S, Shak S, Wolmark N.
J Clin Oncol. 2013 Dec 20;31(36):4512-9.

Biologic determinants of tumor recurrence in stage II colon cancer: validation study of the 12-gene recurrence score in cancer and leukemia group B (CALGB) 9581.
Venook AP, Niedzwiecki D, Lopatin M, Ye X, Lee M, Friedman PN, Frankel W, Clark-Langone K, Millward C, Shak S, Goldberg RM, Mahmoud NN, Warren RS, Schilsky RL, Bertagnolli MM.
J Clin Oncol. 2013 May 10;31(14):1775-81.

Validation study of a quantitative multigene reverse transcriptase-polymerase chain reaction assay for assessment of recurrence risk in patients with stage II colon cancer.
Gray RG, Quirke P, Handley K, Lopatin M, Magill L, Baehner FL, Beaumont C, Clark-Langone KM, Yoshizawa CN, Lee M, Watson D, Shak S, Kerr DJ.
J Clin Oncol. 2011 Dec 10;29(35):4611-9.

 

Prostate Cancer

Patient-specific meta-analysis of two clinical validation studies to predict pathologic outcomes in prostate cancer using the 17-gene Genomic Prostate Score.
Brand TC, Zhang N, Crager MR, Maddala T, Dee A, Sesterhenn IA, Simko JP, Cooperberg MR, Srivastava S, Rosner IL, Chan JM, Febbo PG, Carroll PR, Cullen J, Lawrence HJ.
Urology. 2016; 89:69-75.

A 17-gene assay to predict prostate cancer aggressiveness in the context of Gleason grade heterogeneity, tumor multifocality, and biopsy undersampling
Klein EA, Cooperberg MR, Magi-Galluzzi C, Simko JP, Falzarano SM, Maddala T, Chan JM, Li J, Cowan JE, Tsiatis AC, Cherbavaz DB, Pelham RJ, Tenggara-Hunter I, Baehner FL, Knezevic D, Febbo PG, Shak S, Kattan MW, Lee M, Carroll PR.
Eur Urol. 2014;66(3):550-60.

A biopsy-based 17-gene Genomic Prostate Score predicts recurrence after radical prostatectomy and adverse surgical pathology in a racially diverse population of men with clinically low- and intermediate-risk prostate cancer
Cullen J, Rosner IL, Brand TC, Zhang N, Tsiatis AC, Moncur J, Ali A, Chen Y, Knezevic D, Maddala T, Lawrence HJ, Febbo PG, Srivastava S, Sesterhenn IA, McLeod DG.
Eur Urol. 2014;68(1):123-31.

Treatment Guidelines

The Oncotype DX Breast Cancer Assay is the only multi-gene breast cancer assay considered standard of care and incorporated into major international breast cancer treatment guidelines based on its proven ability to predict chemotherapy benefit for patients with early stage breast cancer.

2015 NCCN Clinical Practice Guidelines in Oncology: Breast Cancer1
  • The current NCCN Guidelines include the Oncotype DX Breast Cancer Assay to quantify the risk of recurrence as a continuous variable and predict responsiveness to adjuvant therapy (i.e., endocrine therapy and/or chemotherapy) for patients with ER-positive, HER2-negative, > 0.5 cm tumors that are node-negative or N1mi (≤ 2 mm axillary node metastasis)
  • The Oncotype DX Recurrence Score result can be considered for select patients with 1-3 involved ipsilateral axillary lymph nodes to guide the addition of combination chemotherapy to standard hormone therapy

2007 Update of Recommendations for Use of Tumor Markers in Breast Cancer2
  • The Oncotype DX Breast Cancer Assay is included for use in patients newly diagnosed with ER-positive, node-negative invasive breast cancer to predict risk of recurrence in patients treated with tamoxifen
  • The Oncotype DX Breast Cancer Assay may be used to identify which patients with ER-positive, node-negative invasive breast cancer are likely to benefit from tamoxifen and those who may not require adjuvant chemotherapy

2015 International Expert Consensus on the Primary Therapy of Early Breast Cancer3
  • The 14th St. Gallen International Breast Cancer Conference Expert Panel, for the third time, recognized the Oncotype DX Breast Cancer Assay as the only multigene test that is validated to predict chemotherapy benefit, in addition to providing prognostic information
  • Additionally, 43.8% of the panel supported the prognostic value of the Oncotype DX Breast Cancer Assay beyond 5 years as it relates to extending hormonal therapy in years 5-10

2013 Recommendations for Adjuvant Chemotherapy Decisions in Early-Stage Breast Cancer4
  • The Oncotype DX Breast Cancer Assay is the only multigene assay recommended as an option for guiding adjuvant chemotherapy treatment decisions for qualified patients with early-stage, node-negative invasive breast cancer
    • The analytical and clinical validity and clinical utility of the test is supported by “the most robust evidence base”
    • The test would be a cost-effective use of National Health Service (NHS) resources in people at intermediate risk5 of distant recurrence, when the decision to prescribe chemotherapy remains unclear

2015 ESMO Clinical Guidelines for Primary Breast Cancer6
  • The Oncotype DX Breast Cancer Assay Recurrence Score result may be utilized to gain additional prognostic and/or predictive information to complement pathology assessment and to predict response to adjuvant chemotherapy, particularly in patients with ER-positive early-stage breast cancer
  • The Oncotype DX Breast Cancer Assay may be used to determine individual recurrence risk and predict benefit from chemotherapy, in cases of uncertainty regarding indications for adjuvant chemotherapy
  • The Oncotype DX Breast Cancer Assay may be used in conjunction with clinicopathological factors to help in treatment decision-making in some cases of difficult decision, such as grade 2, ER-positive, HER2-negative and node-negative breast cancer

 

 

* NCCN is a registered trademark of the National Comprehensive Cancer Network; ASCO is a registered trademark of the American Society of Clinical Oncology. NCCN and ASCO do not endorse any therapy or product.

1NCCN clinical practice guidelines in oncology. V.2.2015.
2Harris et al. J Clin Oncol. 2007.
3Coates et al. Ann Oncol. 2015.
4NICE diagnostics guidance 10. 2013.
5Intermediate risk of distant recurrence is defined as Nottingham
6Senkus et al. Ann Oncol. 2015.

Oncotype DX: The Only Genomic Breast Cancer Test with Prospective Outcomes Data

Watershed TAILORx trial finds 99% of women with low Oncotype DX Recurrence Scores® are free of breast cancer recurrence after five years of hormone therapy alone. Learn more about this historic study published in the New England Journal of Medicine.

Nature Partner Journals publish five-year outcomes results from SEER Registry demonstrating Oncotype DX accurately identifies early-stage breast cancer patients with excellent survival. Read the study in the Nature Partner Journal.

Decision Impact

Numerous studies from around the world consistently demonstrate that Oncotype DX changes physician treatment recommendations 30-40% of the time, underscoring its significant impact in clinical practice.

 

Breast Cancer

Clinical Utility of the 12-Gene DCIS Score Assay: Impact on Radiotherapy Recommendations for Patients with Ductal Carcinoma In Situ.
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.
Ann Surg Oncol. 2016 Oct 4. [Epub ahead of print]

Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER1) node-negative breast cancer.
J. Albanell, A. Gonzalez, M. Ruiz-Borrego, et al.
Ann Oncol.

Impact of the 21-Gene Recurrence Score Assay Compared With Standard Clinicopathologic Guidelines in Adjuvant Therapy Selection for Node-Negative, Estrogen Receptor-Positive Breast Cancer.
Partin JF, Mamounas EP.
Annals of Surgical Oncology

The impact of the 21-gene recurrence score assay on decision making about adjuvant chemotherapy in early-stage estrogen-receptor-positive breast cancer in an oncology practice with a unified treatment policy.
Geffen DB, Abu-Ghanem S, Sion-Vardy N, Braunstein R, Tokar M, Ariad S, Delgado B, Bayme M, Koretz M.
Ann Oncol.

Physician Survey of the Effect of the 21-Gene Recurrence Score Assay Results on Treatment Recommendations for Patients With Lymph Node–Positive, Estrogen Receptor–Positive Breast Cancer
Ruth Oratz, MD, FACP, Benjamin Kim, MD, MPhil, Calvin Chao, MD, Stanley Skrzypczak, MS, Caron Ory, RN, MSN, Roberto Bugarini, DStat, and Michael Broder, MD, FACOG
Journal of Oncology Practice 2011.

Prospective Multicenter Study of the Impact of the 21-Gene Recurrence Score Assay on Medical Oncologist and Patient Adjuvant Breast Cancer Treatment Selection.
Shelly S. Lo,*Patricia B. Mumby, ­John Norton, ­Karen Rychlik, ­Jeffrey Smerage, ­Joseph Kash, ­Helen K. Chew, ­Ellen R. Gaynor, ­Daniel F. Hayes, ­Andrew Epstein, ­and Kathy S. Albain

Association Between the 21-Gene Recurrence Score Assay and Risk of Locoregional Recurrence in Node-Negative, Estrogen Receptor–Positive Breast Cancer: Results From NSABP B-14 and NSABP B-20. 
Eleftherios P. Mamounas,*­Gong Tang, ­Bernard Fisher, ­Soonmyung Paik, ­Steven Shak, ­Joseph P. Costantino, ­Drew Watson, ­Charles E. Geyer Jr, ­D. Lawrence Wickerham, ­and Norman Wolmark

The influence of a gene expression profile on breast cancer decisions.
Henry L, Stojadinovic A, Swain SM et al.
Journal of Surgical Oncology:319–323.

Does Oncotype DX recurrence score affect management of patients with early –stage breast cancer? 
Asad J, Jacobson A, Estabrook A et al.
Am J Manag Care. 2008;American Journal of Surgery:527–529.

Low Recurrence Score by the Oncotype DX Breast Cancer Assay Rarely Results in Recommendation for or Administration of Chemotherapy: A Pooled Analysis
P Hall, S Skrzypczak, G Palmer
Abstract #2601: Poster Session

Impact of a Commercial Reference Laboratory Test Recurrence Score on Decision Making in Early-Stage Breast Cancer
R Oratz, D Paul, AL Cohn, SM Sedlacek
3(4):182-186.

Development and Clinical Utility of a 21-Gene Recurrence Score Prognostic Assay in Patients with Early Breast Cancer Treated with Tamoxifen
S Paik
12(6):631-635.

A Retrospective Analysis of the Impact of Oncotype DX Low Recurrence Score Results on Treatment Decisions in a Single Academic Breast Cancer Center
H Liang, AM Brufsky, BB Lembersky, P Rastogi, VG Vogel
Abstract #2061 : Poster Session

Evaluation of Practice Patterns in the Treatment of Node-Negative, Hormone-Receptor Positive Breast Cancer Patients with the Use of the Oncotype DX Assay at the University of Pennsylvania
C Erb, KR Fox, M Patel, K Hook, A DeMichele, C Kaplan, S Domchek
Abstract #3082 : Poster Session

Prospective Multi-Center Study of the Impact of the 21-Gene Recurrence Score (RS) Assay on Medical Oncologist (MO) and Patient (PT) Adjuvant Breast Cancer (BC) Treatment Selection
SS Lo, J Norton, PB Mumby, J Smerage, J Kash, HK Chew, D Hayes, A Epstein, KS Albain
Abstract #577 : Poster Session

Roadmap for Developing and Validating Therapeutically Relevant Genomic Classifiers
R Simon
J Clin Oncol. 2005;23(29):7332-7341.

Impact of Oncotype DX™ on Decision Making in Breast Cancer Clinical Practice
R Oratz, D Paul, A Cohn, S Sedlacek
Abstract #2049 : Poster Session

Prospective Multi-Center Study of the Impact of the 21-Gene Recurrence Score Assay on Patient Satisfaction, Anxiety and Decisional Conflict for Adjuvant Breast Cancer Treatment Selection
PB Mumby, SS Lo, J Norton, J Smerage, K Joseph, HK Chew, D Hayes, KS Albain
Abstract #1092 : Poster Session

 

Prostate Cancer

The impact of a biopsy based 17-gene Genomic Prostate Score on treatment recommendations in men with newly diagnosed clinically prostate cancer who are candidates for active surveillance
Badani KK, Kemeter MJ, Febbo PG, Lawrence HJ, Denes BS, Rothney MP, Rothberg MB, Brown GA.
Urology Practice. 2015;2(4):181-9.

Utility of the Oncotype DX prostate cancer assay in clinical practice for treatment selection in men newly diagnosed with prostate cancer (PCa): a retrospective chart review analysis
Dall'Era M, Maddala T, Polychronopoulos L, Gallagher JR, Febbo PG, Denes BS.
Urology Practice. 2015;2(6):343–8.

Health Economics

Our tests have saved more than $3.5 billion in cancer treatment costs for more than 700,000 patients worldwide.



Does Oncotype DX recurrence score affect management of patients with early –stage breast cancer? 
Asad J, Jacobson A, Estabrook A et al.
Am J Manag Care. 2008;American Journal of Surgery:527–529.

Impact of a 21-Gene RT-PCR Assay on Treatment Decisions in Early-Stage Breast Cancer, An Economic Analysis Based on Prognostic and Predictive Validation Studies
GH Lyman, LE Cosler, NM Kuderer, J Hornberger
109(6):1011-1018.

21-Gene RT-PCR Assay in Lymph Node-Negative (LN-), Estrogen Receptor-Positive (ER+) Breast Cancer: An Economic Analysis Including Prognostic and Predictive Information
LE Cosler, NM Kuderer, J Hornberger, GH Lyman
Abstract #6024 : Poster Discussion

Roadmap for Developing and Validating Therapeutically Relevant Genomic Classifiers
R Simon
J Clin Oncol. 2005;23(29):7332-7341.

Economic Analysis of Targeting Chemotherapy Using a 21-Gene RT-PCR Assay in Lymph Node-Negative, Estrogen Receptor-Positive, Early-Stage Breast Cancer
J Hornberger, LE Cosler, GH Lyman
11(5):313-324.

A 21-Gene RT-PCR Assay in Lymph Node-Negative (LN-), Estrogen Receptor-Positive (ER+) Early-Stage Breast Cancer (ESBC): An Age-Specific Economic Analysis
GH Lyman, L Cosler, J Hornberger
Abstract #2081 : Poster Discussion

Economic Analysis of Targeting Chemotherapy (CT) Using a 21-Gene RT-PCR Assay in Lymph Node-Negative (LN-), Estrogen Receptor-Positive (ER+) Early-Stage Breast Cancer (ESBC)
LE Cosler, J Hornberger, GH Lyman
Abstract #6036 : Poster Session

Prognostic Role of a Multigene Reverse Transcriptase-PCR Assay in Patients with Node-Negative Breast Cancer Not Receiving Adjuvant Systemic Therapy
FJ Esteva, AA Sahin, M Cristofanilli, K Coombes, SJ Lee, J Baker, M Cronin, MG Walker, D Watson, S Shak, GN Hortobagyi
Abstract #17 : Oral Presentation

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