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| Frequently Asked Questions The following is a list of frequently asked questions about the Oncotype DX® Breast Cancer Assay. What is Oncotype DX? Which patients are appropriate for the Oncotype DX assay? When should Oncotype DX be used? How accurate are the results of Oncotype DX? Is Oncotype DX recommended in guidelines? How does the Recurrence Score™ correlate with a patient's likelihood of distant recurrence? How was the gene panel for Oncotype DX developed and validated? Can Oncotype DX provide information about chemotherapy benefit? How do I order the Oncotype DX assay? What type of tumor sample is required for Oncotype DX? How much tumor tissue is required? How are the results of Oncotype DX reported? What is the turnaround time for Oncotype DX results? Is Oncotype DX currently available? Is Oncotype DX covered by health insurance? How should international specimens be handled? Why do the Oncotype DX reports include quantitative estrogen receptor (ER) and progesterone receptor (PR) Scores? How do the quantitative ER and PR Scores compare with measurements from my local pathology lab by IHC? What information do the quantitative ER and PR Scores provide? Q: What is Oncotype DX? A: Oncotype DX is a diagnostic assay that quantifies the likelihood of breast cancer recurrence in women with newly diagnosed, stage I or II, node-negative breast cancer treated with tamoxifen or node-positive, hormone receptor positive breast cancer in post-menopausal women who will be treated with tamoxifen. The test also predicts the likelihood of chemotherapy benefit for those patients. A recent study also indicated that the Oncotype DX assay is also 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. Q: Which patients are appropriate for the Oncotype DX assay? A: Oncotype DX is clinically validated for newly diagnosed breast cancer patients who are either:
A: Oncotype DX can be ordered as soon as resected tumor tissue is available for submission to Genomic Health. Oncotype DX is intended for use in women newly diagnosed with early stage invasive breast cancer who are either Stage I/II node negative, estrogen-receptor positive or postmenopausal, node positive, hormone receptor positive and provides information that may be used to enhance treatment planning. Q: How accurate are the results of Oncotype DX? A: Oncotype DX was developed in extensive laboratory and clinical studies and was validated in an independent clinical studies with prospectively-defined endpoints. The results of the initial validation study of Oncotype DX in Stage I/II, node negative, estrogen-receptor positive breast cancer were published in The New England Journal of Medicine (December 30, 2004). Q: Is Oncotype DX recommended in guidelines? A: Both ASCO (American Society of Clinical Oncology) and NCCN (National Comprehensive Cancer Network) have included Oncotype DX in their guidelines as an option to help determine whether patients with node negative, estrogen receptor positive breast cancer will benefit from chemotherapy. Q: How does the Recurrence Score correlate with a patient's likelihood of distant recurrence? A: The Oncotype DX Recurrence Score is provided on a scale of 0 to 100. Each Recurrence Score 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 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 (both prognosis and likelihood of chemotherapy benefit (CAF). Click here to review the Oncotype DX report form. Q: How was the gene panel for Oncotype DX developed and validated? A: The identification of the gene panel for Oncotype DX 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. Q: Can Oncotype DX provide information about chemotherapy benefit? A: In addition to quantifying breast cancer recurrence risk, Oncotype DX also assesses the benefit from chemotherapy.1 Click here for more information about chemotherapy benefit.2 Q: How do I order the Oncotype DX assay? A: 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. Q: What type of tumor sample is required for Oncotype DX? A: Oncotype DX is performed using formalin-fixed, paraffin-embedded invasive breast tumor tissue obtained by lumpectomy, mastectomy, or core biopsy. Q: How much tumor tissue is required? A: The Oncotype DX assay requires either one tumor block OR six 10-micron sections of tissue (three in each of two tubes) and an H&E slide from the same block. When blocks are submitted, typically 35 to 65 microns of tissue will be used. Q: How are the results of Oncotype DX reported? A: The results of Oncotype DX are presented as a Recurrence Score (0-100). In addition to the individual test results, an overview of the clinical validation study is provided which correlates Recurrence Score 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 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) and PR (Progesterone Receptor) 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 to see the sample Node Negative report. Click here to see the sample Node Positive report. Q: What is the turnaround time for Oncotype DX results? A: The results of the Oncotype DX assay will typically be available within 10 to 14 days from the date the specimen is received at Genomic Health. The results of the test will be returned via fax, overnight mail, or secure online transfer. Q: Is Oncotype DX currently available? A: Oncotype DX is available and the Genomic Health Laboratory is accepting patient samples. As of December 2007, the assay has been ordered by over 7500 MDs for over 46,500 patients since January 2004. Click here for information about sample submission. Q: Is Oncotype DX covered by health insurance? A: Genomic Health is pleased that many payers representing more than 175 million lives covered have established favorable coverage policies for Oncotype DX for node negative, estrogen receptor positive patients. It is unknown at this time whether payers will cover Oncotype DX 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. Q: How should international specimens be handled? A: Genomic Health is able to accept specimens from outside the US 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 US 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. Q: Why do the Oncotype DX reports include quantitative estrogen receptor (ER) and progesterone receptor (PR) Scores? A: Genomic Health's research has revealed that both ER and PR, as measured using RT-PCR by Oncotype DX, 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, Genomic Health concluded that reporting the quantitative ER and PR Scores together with the Recurrence Score result as part of the Oncotype DX 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. Q: How do the quantitative ER and PR Scores compare with measurements from my local pathology lab by IHC? A: 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 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. Q: What information do the quantitative ER and PR Scores provide? A: The quantitative ER and PR Scores can:
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