Analytical validation of the Oncotype DX genomic diagnostic test for recurrence prognosis and therapeutic response prediction in node-negative, estrogen receptor-positive breast cancer - PubMed (original) (raw)
. 2007 Jun;53(6):1084-91.
doi: 10.1373/clinchem.2006.076497. Epub 2007 Apr 26.
Affiliations
- PMID: 17463177
- 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 et al. Clin Chem. 2007 Jun.
Abstract
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.
Similar articles
- Does oncotype DX recurrence score affect the management of patients with early-stage breast cancer?
Asad J, Jacobson AF, Estabrook A, Smith SR, Boolbol SK, Feldman SM, Osborne MP, Boachie-Adjei K, Twardzik W, Tartter PI. Asad J, et al. Am J Surg. 2008 Oct;196(4):527-9. doi: 10.1016/j.amjsurg.2008.06.021. Am J Surg. 2008. PMID: 18809056 - Translating tumor biology into personalized treatment planning: analytical performance characteristics of the Oncotype DX Colon Cancer Assay.
Clark-Langone KM, Sangli C, Krishnakumar J, Watson D. Clark-Langone KM, et al. BMC Cancer. 2010 Dec 23;10:691. doi: 10.1186/1471-2407-10-691. BMC Cancer. 2010. PMID: 21176237 Free PMC article. - Gene-expression assays: new tools to individualize treatment of early-stage breast cancer.
Dobbe E, Gurney K, Kiekow S, Lafferty JS, Kolesar JM. Dobbe E, et al. Am J Health Syst Pharm. 2008 Jan 1;65(1):23-8. doi: 10.2146/ajhp060352. Am J Health Syst Pharm. 2008. PMID: 18159035 Review. - Association between partial-volume corrected SUVmax and Oncotype DX recurrence score in early-stage, ER-positive/HER2-negative invasive breast cancer.
Lee SH, Ha S, An HJ, Lee JS, Han W, Im SA, Ryu HS, Kim WH, Chang JM, Cho N, Moon WK, Cheon GJ. Lee SH, et al. Eur J Nucl Med Mol Imaging. 2016 Aug;43(9):1574-84. doi: 10.1007/s00259-016-3418-1. Epub 2016 May 21. Eur J Nucl Med Mol Imaging. 2016. PMID: 27209424 - Commercialized multigene predictors of clinical outcome for breast cancer.
Ross JS, Hatzis C, Symmans WF, Pusztai L, Hortobágyi GN. Ross JS, et al. Oncologist. 2008 May;13(5):477-93. doi: 10.1634/theoncologist.2007-0248. Oncologist. 2008. PMID: 18515733 Review.
Cited by
- Evaluating differences in optical properties of indolent and aggressive murine breast tumors using quantitative diffuse reflectance spectroscopy.
Rodriguez Troncoso J, Marium Mim U, Ivers JD, Paidi SK, Harper MG, Nguyen KG, Ravindranathan S, Rebello L, Lee DE, Zaharoff DA, Barman I, Rajaram N. Rodriguez Troncoso J, et al. Biomed Opt Express. 2023 Nov 2;14(12):6114-6126. doi: 10.1364/BOE.505153. eCollection 2023 Dec 1. Biomed Opt Express. 2023. PMID: 38420330 Free PMC article. - Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation.
Gonçalves-Reis M, Proença D, Frazão LP, Neto JL, Silva S, Pinto-Marques H, Pereira-Leal JB, Cardoso J. Gonçalves-Reis M, et al. Pract Lab Med. 2024 Feb 5;39:e00365. doi: 10.1016/j.plabm.2024.e00365. eCollection 2024 Mar. Pract Lab Med. 2024. PMID: 38371895 Free PMC article. - Invasive Breast Cancer with HER2 ≥4.0 and <6.0: Risk Classification and Molecular Typing by a 21-Gene Expression Assay and MammaPrint Plus BluePrint Testing.
Bai Q, Lv H, Bao L, Yang Y, Zhang X, Chang H, Xue T, Ren M, Zhu X, Zhou X, Yang W. Bai Q, et al. Breast Cancer (Dove Med Press). 2023 Aug 3;15:563-575. doi: 10.2147/BCTT.S420738. eCollection 2023. Breast Cancer (Dove Med Press). 2023. PMID: 37554155 Free PMC article. - Prognostic value of tumor necrosis based on the evaluation of frequency in invasive breast cancer.
Chen J, Li Z, Han Z, Kang D, Ma J, Yi Y, Fu F, Guo W, Zheng L, Xi G, He J, Qiu L, Li L, Zhang Q, Wang C, Chen J. Chen J, et al. BMC Cancer. 2023 Jun 9;23(1):530. doi: 10.1186/s12885-023-10943-x. BMC Cancer. 2023. PMID: 37296414 Free PMC article. - BrcaDx: precise identification of breast cancer from expression data using a minimal set of features.
Muthamilselvan S, Palaniappan A. Muthamilselvan S, et al. Front Bioinform. 2023 May 23;3:1103493. doi: 10.3389/fbinf.2023.1103493. eCollection 2023. Front Bioinform. 2023. PMID: 37287543 Free PMC article.
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical