Journal Article
. 2007 Apr;53(6).
doi: 10.1373/clinchem.2006.076497.

Analytical validation of the Oncotype DX genomic diagnostic test for recurrence prognosis and therapeutic response prediction in node-negative, estrogen receptor-positive breast cancer

Maureen Cronin 1 Chithra Sangli  Mei-Lan Liu  Mylan Pho  Debjani Dutta  Anhthu Nguyen  Jennie Jeong  Jenny Wu  Kim Clark Langone  Drew Watson  
  • PMID: 17463177
  •     122 citations


Background: Oncotype DX is a clinically validated, high-complexity, multianalyte reverse transcription-PCR genomic test that predicts the likelihood of breast cancer recurrence in early-stage, node-negative, estrogen receptor-positive breast cancer. The Recurrence Score (RS) provides a more accurate, reproducible measure of breast cancer aggressiveness and therapeutic responsiveness than standard measures. Individualized patient management requires strict performance criteria for clinical laboratory tests. We therefore investigated the analytical performance of the assay.

Methods: Assays used a pooled RNA sample from fixed paraffin-embedded tissues to evaluate the analytical performance of a 21-gene panel with respect to amplification efficiency, precision, linearity, and dynamic range, as well as limits of detection and quantification. Performance variables were estimated from assays carried out with sample dilutions. In addition, individual patient samples were used to test the optimized assay for reproducibility and sources of imprecision.

Results: Assay results defined acceptable operational performance ranges, including an estimated maximum deviation from linearity of <1 cycle threshold (C(T)) units over a > or =2000-fold range of RNA concentrations, with a mean quantification bias of 0.3% and CVs of 3.2%-5.7%. An analysis of study design showed that assay imprecision contributed by instrument, operator, reagent, and day-to-day baseline variation was low, with SDs of <0.5 C(T).

Conclusion: The analytical and operational performance specifications defined for the Oncotype DX assay allow the reporting of quantitative RS values for individual patients with an SD within 2 RS units on a 100-unit scale.

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BMC Cancer, 2020 Aug 12; 20(1). PMID: 32778063    Free PMC article.
Identification of a Six-lncRNA Signature With Prognostic Value for Breast Cancer Patients.
Erjie Zhao, Yujia Lan, +5 authors, Jing Hu.
Front Genet, 2020 Aug 28; 11. PMID: 32849766    Free PMC article.
Novel semi-automated algorithm for high-throughput quantification of adipocyte size in breast adipose tissue, with applications for breast cancer microenvironment.
Frank L Lombardi, Naser Jafari, +4 authors, Gerald V Denis.
Adipocyte, 2020 Jul 08; 9(1). PMID: 32633194    Free PMC article.
Identification of a novel subgroup of endometrial cancer patients with loss of thyroid hormone receptor beta expression and improved survival.
Daniel G Piqué, John M Greally, Jessica C Mar.
BMC Cancer, 2020 Sep 08; 20(1). PMID: 32894083    Free PMC article.
Examination of the Biomark assay as an alternative to Oncotype DX for defining chemotherapy benefit.
Jinkyoung Kim, Aeree Kim, Chungyeul Kim.
Oncol Lett, 2019 Jan 25; 17(2). PMID: 30675242    Free PMC article.
Clinical analysis of 21-gene recurrence score test in hormone receptor-positive early-stage breast cancer.
Lizhe Zhu, Nan Ma, +5 authors, Yu Ren.
Oncol Lett, 2019 Jun 13; 17(6). PMID: 31186766    Free PMC article.
Molecular characterization of breast cancer needle core biopsy specimens by the 21-gene Breast Recurrence Score test.
Debbie M Jakubowski, Helen Bailey, +7 authors, Frederick L Baehner.
J Surg Oncol, 2020 Jun 05;. PMID: 32497318    Free PMC article.
Prognostic biomarkers related to breast cancer recurrence identified based on Logit model analysis.
Xiaoying Zhou, Chuanguang Xiao, +6 authors, Lili Lin.
World J Surg Oncol, 2020 Sep 27; 18(1). PMID: 32977823    Free PMC article.
Multifocal/Multicentric Ipsilateral Invasive Breast Carcinomas with Similar Histology: Is Multigene Testing of All Individual Foci Necessary?
Anne Grabenstetter, Edi Brogi, +4 authors, Hannah Y Wen.
Ann Surg Oncol, 2018 Oct 10; 26(2). PMID: 30298311    Free PMC article.
Cancer biomarker discovery and translation: proteomics and beyond.
Ventzislava A Hristova, Daniel W Chan.
Expert Rev Proteomics, 2018 Dec 18; 16(2). PMID: 30556752    Free PMC article.
Clinical target sequencing for precision medicine of breast cancer.
Junko Tsuchida, Jami Rothman, +3 authors, Toshifumi Wakai.
Int J Clin Oncol, 2019 Jan 04; 24(2). PMID: 30604156
[Molecular subtypes of urothelial carcinoma of the bladder-background and clinical relevance].
Philipp Erben, Christoph Becker, +3 authors, Fachgruppe Molekulare Urologie der Arbeitsgruppe urologische Forschung (AuF) der Deutschen Gesellschaft für Urologie.
Urologe A, 2020 Nov 27; 60(1). PMID: 33242119
Nucleic Acid Quantitation with Log-Linear Response Hybridization Probe Sets.
Lucia R Wu, John Z Fang, Dmitriy Khodakov, David Yu Zhang.
ACS Sens, 2020 Jun 02; 5(6). PMID: 32475109    Free PMC article.
How Canadian Oncologists Use Oncotype DX for Treatment of Breast Cancer Patients.
Xiaofu Zhu, Susan Dent, +5 authors, Xinni Song.
Curr Oncol, 2021 Feb 10; 28(1). PMID: 33557029    Free PMC article.
HER2 testing in breast cancers: comparison of assays and interpretation using ASCO/CAP 2013 and 2018 guidelines.
Lauren E McLemore, Constance T Albarracin, +8 authors, Hui Chen.
Breast Cancer Res Treat, 2021 Apr 05; 187(1). PMID: 33813685