Analytical Validation of the Oncotype DX Genomic Diagnostic Test for Recurrence Prognosis and Therapeutic Response Prediction in Node-Negative, Estrogen Receptor–Positive Breast Cancer | Zendy

Maureen Cronin | Zendy; Chithra Sangli | Zendy; MeiLan Liu | Zendy; Mylan Pho | Zendy; Debjani Dutta | Zendy; Anh Nguyen | Zendy; Jennie Jeong | Zendy; Jenny Wu | Zendy; Kim M. Clark-Langone | Zendy; Drew Watson | Zendy

Open Access

Analytical Validation of the Oncotype DX Genomic Diagnostic Test for Recurrence Prognosis and Therapeutic Response Prediction in Node-Negative, Estrogen Receptor–Positive Breast Cancer

Author(s) -

Maureen Cronin,

Chithra Sangli,

MeiLan Liu,

Mylan Pho,

Debjani Dutta,

Anh Nguyen,

Jennie Jeong,

Jenny Wu,

Kim M. Clark-Langone,

Drew Watson

Publication year - 2007

Publication title -

clinical chemistry

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.705

H-Index - 218

eISSN - 1530-8561

pISSN - 0009-9147

DOI - 10.1373/clinchem.2006.076497

Subject(s) - breast cancer , medicine , oncology , reproducibility , estrogen receptor , cancer , statistics , mathematics

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.

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