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Oncotype DX
Oncotype DX, is a commercial diagnostic test that estimates the likelihood of disease recurrence in women with early-stage hormone estrogen receptor (ER) positive only breast cancer (''prognostic'' significance). There is emerging evidence that such tests may also provide information about the likely benefit from chemotherapy (''predictive'' significance).
Oncotype DX analyzes a panel of 21 genes within a tumor to determine a Recurrence Score. The Recurrence Score is a number between 0 and 100 that corresponds to a specific likelihood of breast cancer recurrence within 10 years of the initial diagnosis, though the score is not validated, though the buckets of Low, Intermediate or High Risk are when the patient receives / abides to 5 years of Tamoxifen. With this information, it may be possible for doctors and patients to make more informed decisions about breast cancer treatment options. Oncotype DX is performed by Genomic Health in its CLIA-certified, CAP-accredited reference laboratory.
The test was initially developed for women with early-stage invasive breast cancer with ER+ cancers whose lymph nodes do not contain tumor (node-''negative''). Typically in these cases, treatment with anti-hormonal therapy, such as tamoxifen or aromatase inhibitors, is planned, and the test can help define whether chemotherapy should or should not be added to that anti-hormone treatment.
==Cost and cost-effectiveness==
The current list price of Oncotype DX is $4,175.00. Several studies indicate that the use of the Oncotype DX test is cost-effective in lymph node-negative patients for the United States, Canada and Japan by providing additional information to help doctors tailor treatment to the individual patient.〔Hornberger J, Cosler LE, Lyman GH. Economic analysis of targeting chemotherapy using a 21-gene RT-PCR assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer. Am J Manag Care. 2005;11(5):313-24. PMID 15898220〕〔Tsoi DT, Inoue M, Kelly CM, Verma S, Pritchard KI. Cost-Effectiveness Analysis of Recurrence Score-Guided Treatment Using a 21-Gene Assay in Early Breast Cancer. Oncologist. 2010 Apr 26. PMID 20421264〕〔Kondo M, Hoshi SL, Ishiguro H, Yoshibayashi H, Toi M. Economic evaluation of 21-gene reverse transcriptase-polymerase chain reaction assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer in Japan. Breast Cancer Res Treat. 2008 Nov;112(1):175-87. PMID 18075786〕〔Lyman GH, Cosler LE, Kuderer NM, Hornberger J. 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. Cancer. 2007 Mar 15;109(6):1011-8. PMID 17311307〕 The cost-effectiveness of Oncotype DX in lymph node-positive patients remains highly uncertain.〔Hall PS, McCabe C, Stein RC, Cameron D. J Economic evaluation of genomic test-directed chemotherapy for early-stage lymph node-positive breast cancer. ''J Natl Cancer Inst''. 2012 Jan 4;104(1):56-66. PMID 22138097〕
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