FAQs for Physicians
What is the Oncotype DX assay?
The Oncotype DX diagnostic assay predicts the likelihood of chemotherapy benefit for those patients and quantifies the likelihood of breast cancer recurrence in women with newly diagnosed, stage I or II, node-negative, estrogen receptor-positive breast cancer treated with tamoxifen. A recent study also indicated that the Oncotype DX assay may also be prognostic and predictive of added chemotherapy (CAF) benefit for postmenopausal women with node-positive, hormone-receptor-positive breast cancer treated with tamoxifen. The test analyzes the expression of a panel of 21 genes.
Has the Oncotype DX assay been approved for use in the U.S.?
Research and validation studies have already been performed on the 21-Gene Oncotype DX Breast Cancer Assay for the following indications: N-, ER+; Single Gene Reporting of ER/PR; N+. The Oncotype DX assay for these indications is currently commercially available. The Oncotype DX assay was developed and its performance characteristics were determined by Genomic Health, Inc. The laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. The Oncotype DX assay is used for clinical purposes, and it should not be regarded as investigational or for research. Oncotype DX assay results are adjunctive to the ordering physician’s workup.
Which patients are appropriate for the Oncotype DX Breast Recurrence Score?
The Oncotype DX Breast Recurrence Score is clinically validated for newly diagnosed breast cancer patients who are:
- Node-negative or node-positive (1-3)
- Hormone-receptor-positive (ER+ or PR+)*
- Human epidermal growth factor receptor 2 negative (HER2-)
* As of September 21, 2009, Genomic Health accepts all appropriate early stage breast cancer tumor samples regardless of IHC ER status to facilitate the accurate identification of patients who are ER-positive by either IHC or RT-PCR.
When should the Oncotype DX Breast Recurrence Score be used?
The Oncotype DX Breast Recurrence Score can be ordered as soon as resected tumor tissue is available for submission to Genomic Health. The Oncotype DX Breast Recurrence Score is intended for use in women newly diagnosed with early stage invasive breast cancer who are node-negative or node-positive (1-3), hormone-receptor-positive (ER+ or PR+), and human epidermal growth factor receptor 2 negative (HER2-). The test provides information that may be used to enhance treatment planning.
How accurate are the results of the Oncotype DX assay?
The Oncotype DX assay was developed in extensive laboratory and clinical studies and was validated in an independent clinical study with prospectively-defined endpoints. The results of the initial validation study of the Oncotype DX assay in stage I/II, node-negative, estrogen-receptor-positive breast cancer were published in The New England Journal of Medicine (December 30, 2004).
Is the Oncotype DX assay included in guidelines?
Both ASCO® (American Society of Clinical Oncology®) and NCCN® (National Comprehensive Cancer Network®) have included the Oncotype DX assay in their guidelines as an option to help determine whether patients with node-negative, estrogen-receptor-positive breast cancer will benefit from chemotherapy.
American Society of Clinical Oncology (ASCO) and ASCO are registered
trademarks of ASCO; National Comprehensive Cancer Network (NCCN) and NCCN are registered
trademarks of NCCN. ASCO and NCCN do not endorse any product of therapy.
How does the Recurrence Score® result correlate with a patient's likelihood of distant recurrence?
The Oncotype DX Assay Recurrence Score result is provided on a scale of 0 to 100. Each Recurrence Score result is calculated based on the results of the patient's tumor gene expression profile. For node-negative, estrogen-receptor-positive breast cancer patients treated with tamoxifen, the Recurrence Score result correlates to a specific likelihood of distant recurrence as observed in the clinical validation study as well as likelihood of chemotherapy benefit (CMF/MF). For node-positive, estrogen-receptor-positive post-menopausal patients treated with tamoxifen, the report form now includes the SWOG 8814 study which evaluated risk of recurrence or death vs the Recurrence Score result (both prognosis and likelihood of chemotherapy benefit [CAF]).
How was the gene panel for the Oncotype DX assay developed and validated?
The identification of the gene panel for the Oncotype DX assay started with an extensive analysis of the human genome. Following the identification of a large set of genes associated with breast cancer, three studies explored the expression of 250 genes in patient tumor samples that were obtained at the time of initial diagnosis. The results of these studies were analyzed and used to develop a 21-gene assay that incorporated the genes which consistently correlated with distant recurrence-free survival. This assay was then validated, using prospectively-defined endpoints, in an independent clinical study of over 650 patient tumor samples from the tamoxifen-alone arm of the landmark NSABP Study B-14.
Can the Oncotype DX assay provide information about chemotherapy benefit?
In addition to quantifying breast cancer recurrence risk, the Oncotype DX assay also assesses the benefit from chemotherapy.1
1. The data on chemotherapy benefit is derived from the NSABP Study B-20 which compared hormonal therapy alone versus CMF-based chemotherapy and hormonal therapy.
How do I order the Oncotype DX assay?
Materials necessary for sample collection and submission are provided in the Oncotype® Specimen Kit, which can be ordered through Genomic Health. Tumor samples are submitted to the Genomic Health Laboratory for analysis. Click here for more information about ordering the assay.
What type of tumor sample is required for the Oncotype DX assay?
The Oncotype DX assay is performed using formalin-fixed, paraffin-embedded invasive breast tumor tissue obtained by lumpectomy, mastectomy or core biopsy.
How much tumor tissue is required?
The Oncotype DX assay requires one tumor block and an H&E slide from the same block. When blocks are submitted, typically 35 to 65 microns of tissue will be used.
How are the results of the Oncotype DX assay reported?
The results of the Oncotype DX assay are presented as a Recurrence Score result (0-100). In addition to the individual test results, an overview of the clinical validation study is provided which correlates Recurrence Score result with likelihood of distant recurrence at 10 years for node-negative, ER-positive patients treated with tamoxifen. The node-negative report now includes results from the NSABP B-20 study of chemotherapy benefit according to the Recurrence Score result for node-negative, estrogen-receptor-positive patients treated with tamoxifen. The node-positive report includes results from the SWOG 8814 study of prognosis and chemotherapy benefit for node-positive, hormone-receptor-positive post-menopausal patients treated with tamoxifen. The final page of both reports displays the ER (Estrogen Receptor), PR (Progesterone Receptor) and HER2 Scores, based on the assessment of the expression of each of these genes. The report form itself is delivered via fax, overnight mail or secure online transfer. Click here for more information on reports.
What is the turnaround time for the Oncotype DX assay results?
Oncotype DX results are reported within 14 calendar days of receipt of the specimen, 90% of the time. The results of the test will be returned via fax, overnight mail or secure online transfer.
Is the Oncotype DX assay currently available?
The Oncotype DX assay is available and the Genomic Health laboratory is accepting patient samples. As of December 2007, the assay has been ordered by over 7,500 MDs for over 65,000 patients since January 2004. Click here for information about sample submission.
Is the Oncotype DX assay covered by health insurance?
Genomic Health is pleased that many payers representing more than 200 million lives covered have established favorable coverage policies for the Oncotype DX assay for node-negative, estrogen-receptor-positive patients. It is unknown at this time whether payers will cover the Oncotype DX assay for patients with node-positive breast cancer. Through our Genomic Access Program (GAP), authorized healthcare providers can request that a benefits investigation be performed for a patient to provide her with information about her specific coverage and potential financial responsibility. Click here for more information about insurance coverage and reimbursement.
How should international specimens be handled?
Genomic Health is able to accept specimens from outside the U.S. for the Oncotype DX Breast Cancer Assay. In addition to all other requirements for these specimens, payment is required prior to processing. Payment can be accepted in the form of valid credit card information, submitted on the Requisition Form or an international money order in U.S. dollars. A Customs Declaration is also required for the specimen to be accepted into the United States. A sample Customs Declaration can be found here. Oncotype Specimen Kits comply with international packaging regulations for diagnostic specimens (IATA 650 Packaging Instruction). Please contact our Customer Service Department, 866-ONCOTYPE (866-662-6897), in advance to discuss any special requirements.
Why do the Oncotype DX assay reports include quantitative estrogen receptor (ER) and progesterone receptor (PR) Scores?
Genomic Health's research has revealed that both ER and PR, as measured using RT-PCR by the Oncotype DX assay, have a wide range of expression across a continuum that is not reported by other methods that are commonly available. Based on this information, and given that the ER and PR scores are generated with the analysis that generates the Recurrence Score result, Genomic Health concluded that reporting the quantitative ER and PR Scores together with the Recurrence Score result as part of the Oncotype DX assay report was appropriate to provide additional insight into the biology of individual tumors. These data are included in reports generated on or after February 1, 2008.
How do the quantitative ER and PR Scores compare with measurements from my local pathology lab by IHC?
ER and PR by IHC measure protein expression by staining receptors on the cell surface. Quantitative ER and PR by RT-PCR measure the RNA expression of these genes. Several studies of invasive breast carcinomas have demonstrated high concordance between ER and PR by IHC and quantitative ER and PR by RT-PCR. ER and PR Scores constitute a precise, reproducible and alternate method to determine a patient’s ER and PR status.
What information do the quantitative ER and PR Scores provide?
The quantitative ER and PR Scores can:
- Help determine the likelihood that an individual patient will derive a substantial benefit from tamoxifen
- Provide additional information for clinical decision making for a patient whose ER protein expression is borderline positive by IHC or reported as uncertain
- Provide further insight into the Recurrence Score result
Why is Genomic Health reporting out quantitative HER2 scores?
Many clinicians who rely on Recurrence Score results for treatment planning have requested that Genomic Health also report a quantitative HER2 Score as a means to complement current testing and potentially provide further clarification of conflicting or ambiguous results. The Recurrence Score result remains the best tool for assessing prognosis and prediction of chemotherapy benefit.
What information does the quantitative HER2 score provide?
The quantitative HER2 score can provide a greater level of confidence in cases of equivocal IHC and/or FISH results or discordance between FISH and IHC.
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