With the increasing prevalence of ductal carcinoma in situ (DCIS) , there is a significant unmet need to determine which women with DCIS are at high risk of having either a DCIS or an invasive carcinoma local recurrence. The Oncotype DX® Breast Cancer Assay for DCIS patients is the first clinically validated genomic assay to provide an individualized prediction of the 10-year risk of local recurrence (DCIS or invasive carcinoma) to help guide treatment decision-making in women with ductal carcinoma in situ treated by local excision, with or without tamoxifen.
The Oncotype DX Assay for DCIS Patients:
- Is the first and only clinically-validated genomic assay for patients with DCIS.
- Predicts the risk of local recurrence (DCIS or invasive carcinoma) and predicts the risk of local invasive carcinoma.
- Helps guide personalized treatment based on tumor biology as determined by the DCIS Score™.
- The DCIS score was clinically validated in a prospectively designed study using patient samples from ECOG 51941.
- Offers additional information: the report includes quantitative ER and PR single gene expression values.
- Genomic Health is a CLIA-certified, CAP-accredited reference laboratory and is a leader in the field of cancer genomics.
Which Patients?
The Oncotype DX Breast Cancer Assay for DCIS patients provides clinical experience information:
- For women with ductal carcinoma in situ treated by local excision, with or without tamoxifen.
DCIS Score Result
DCIS is a heterogeneous disease. Currently there is no objective method to identify patients who are at a high risk of local recurrence or determine which recurrences will be invasive. It is important to have an accurate and reproducible assay that predicts the risk of recurrence for DCIS patients. Reflective of the continuum of DCIS tumor biology the DCIS Score quantifies: (1) the likelihood of local recurrence (DCIS or invasive carcinoma) at 10 years; and, (2) predicts specifically the risk of an invasive carcinoma local event at 10 years. The DCIS Score result provides you and your patients with an individualized score to help inform your treatment plan.
1. Hughes LL, Wang M, Page DL et al. (2009). “Local excision alone without irradiation for ductal carcinoma in situ of the breast: a trial of the Eastern Cooperative Oncology Group”. J Clin Oncol, 27: 5319-5324.
Downloadable Files
2011 SABCS Presentation on a Prospective Validation Study of the DCIS Score from ECOG E5194
The Oncotype DX Breast Cancer Assay for DCIS Patients
The Oncotype DX Breast Cancer Assay for DCIS is a multi-gene diagnostic assay designed to support personalized treatment planning for patients with DCIS following local excision. The assay provides an individualized estimate of the 10-year risk of local recurrence (DCIS or invasive carcinoma) to help guide treatment decision making in women with ductal carcinoma in situ treated by local excision, with or without tamoxifen.
The Oncotype DX Breast Cancer Assay is performed in the licensed Genomic Health laboratory where the assay was developed. All H&E’s are reviewed by board certified surgical pathologists and the DCIS tumor is marked for manual microdissection. The dissected, enriched tumor sample then undergoes RNA extraction. Next, the RNA is analyzed using a technique called real-time RT-PCR (reverse transcriptase-polymerase chain reaction). Finally, the DCIS Score result is calculated from the gene expression results.
Advantages of RT-PCR
The Oncotype DX Breast Cancer Assay analyzes the expression of a panel of 21 genes from a tumor specimen using a technique called RT-PCR. A high-throughput, real-time RT-PCR method was developed to analyze the expression of select genes. Unlike routine histopathologic H&E slide review or assessment of immunohistochemical stains for hormone receptors, RT-PCR is sensitive, specific, highly reproducible, and has a wide dynamic range. RT-PCR is a mature technology that is routinely utilized in several clinical applications including viral load testing for HIV.
To quantify gene expression, RNA is extracted from formalin-fixed, paraffin-embedded (FPET) tumor tissue and subjected to DNase I treatment. Total RNA content is measured and the absence of DNA contamination is verified. Reverse transcription is performed and is followed by quantitative TaqMan® (Roche Molecular Systems, Inc.) RT-PCR reactions in 384-well plates. The expression of each of 16 cancer related genes is measured in triplicate and then normalized relative to a set of five reference genes.
The Oncotype DX Breast Cancer Assay for DCIS patients standardized testing methods have been optimized to minimize variability due to:
- Sources of pre-analytic variability: delay to fixation, choice of fixative, duration of fixation, age of sample
Oncotype DX Assay Development
The Oncotype DX Breast Cancer Assay for DCIS patients was developed in four steps. Each of these steps is described in detail below.
- Optimization of methods for quantifying gene expression in formalin-fixed, paraffin-embedded tissue (FPET)
- Selection of 250 candidate genes from the human genome
- Testing of candidate genes to identify an optimal gene panel for clinical validation
- Prospective clinical validation of the gene panel and DCIS Score result calculation
Step 1. Optimization of methods for quantifying gene expression in formalin-fixed, paraffin-embedded tissue
The ability to work with FPET samples is critical in the U.S., as this is the standard method for tumor preservation and storage. When tissue is preserved in paraffin, the RNA is fragmented. However, the relative ratio of RNA between genes is unchanged. By utilizing RT-PCR techniques, the expression of most genes—relative to a set of reference genes—can be measured. To develop the Oncotype DX Breast Cancer Assay, Genomic Health researchers optimized RT-PCR technology 1) for high-throughput, real-time quantitation of specific RNA in FPET, and 2) to be reproducible regardless of the variability inherent in tumor blocks.
Step 2. Selection of 250 candidate genes from the human genome
Genomic Health researchers relied on numerous sources to identify 250 candidate genes—those possibly associated with breast cancer tumor behavior—from among the approximately 25,000 genes in the human genome.
Step 3. Testing of candidate genes to identify an optimal gene panel for clinical validation
The 250 candidate genes were analyzed in a total of 447 patients from three independent clinical studies in order to identify a panel of genes strongly correlated with distant recurrence-free survival. The selection of the 16 cancer genes used for the Oncotype DX Breast Cancer Assay was based on the results of the three clinical trials, which demonstrated a consistent and strong statistical link between these genes and distant breast cancer recurrence. Five reference genes were identified to normalize the expression of these cancer-related genes. The 21- gene panel described above has been optimized for the DCIS Score, which is calculated from a subset of the genes using a DCIS-specific algorithm and coefficients.
Step 4. Prospective clinical validation of the DCIS Score
The Oncotype DX Breast Cancer Assay gene panel and DCIS Score result calculation were validated in a large, independent, multicenter clinical trial (ECOG E5194). The endpoints and analysis plan were prospectively defined. The results of this study were presented at the San Antonio Breast Conference 2011 and the results of the ECOG E5194 clinical validation study will be published in the near future.
21-Gene Panel Used to Calculate Recurrence Score® Result
The Oncotype DX Breast Cancer Assay gene panel was selected from the published literature, a genomics database and experiments based on DNA arrays performed on fresh-frozen tissue. The DCIS Score is obtained by performing the Oncotype DX Breast Cancer Assay, using a distinct DCIS algorithm and coefficients that was pre-specified because of its ability to predict recurrence in patients with DCIS regardless of whether adjuvant tamoxifen therapy was given.
Development of the DCIS Score algorithm was based on published results for the Oncotype DX Breast Cancer Assay showing similarity in the expression profiles of the Recurrence Score genes between DCIS and Invasive Breast Cancer (IBC) when both are present within the same patient tumor. The DCIS Score algorithm was developed based on published data obtained from the Kaiser Permanente and NSABP B-14 studies in which the proliferation gene group, PR and GSTM1 were found to predict distant recurrence regardless of whether adjuvant tamoxifen therapy was given. This DCIS Score was subsequently validated as a predictor of local recurrence in patients from the ECOG E5194 study. These results were presented at the San Antonio Breast Conference 2011.
1. Hughes LL, Wang M, Page DL et al. (2009). “Local excision alone without irradiation for ductal carcinoma in situ of the breast: a trial of the Eastern Cooperative Oncology Group”. J Clin Oncol, 27: 5319-5324.
How do I order the Oncotype DX assay?
The tumor analysis requires formalin-fixed, paraffin-embedded tumor tissue. Over 90% of Oncotype DX Assay results are available within 7 to 10 days from the date laboratory processing begins.
U.S. Customers
Over 90% of Oncotype DX Assay results are available within 7 to 10 days from the date laboratory processing begins.
If you are a treating physician and would like to order the Oncotype DX assay, follow the steps below.
- Complete the Oncotype DX Assay Requisition Form or initiate an online order.
- If you want a Benefits Investigation for your patient, complete the Benefits Investigation section. If you don’t want a Benefits Investigation, mark "No Investigation" (for Medicare patients, this would be an appropriate box to select).
- If your patient is uninsured, please contact Genomic Health at
866-ONCOTYPE (866-662-6897).
- For paper orders, fax the completed Oncotype DX Assay Requisition Form to Genomic Health (866-444-0640).
- Genomic Health will complete the Benefits Investigation if desired and will notify the ordering physician and patient of the results.
- Genomic Health will fax the Requisition Form to pathology, if requested by the ordering physician, and obtain and process the patient’s specimen (see Specimen Retrieval section for more details).
- Patient results will be sent to the physician(s) listed on the Requisition Form via online secure access or fax.
International Customers
Genomic Health is able to accept specimens from outside the US for the Oncotype DX Breast Cancer Assay.
Below are ordering/sample submission instructions for international customers.
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- Contact Customer Service at to obtain specimen transportation kit boxes, requisition forms and pathology guidelines for preparation of samples. Kit boxes arrive within 3 to 5 business days.
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- Complete the Oncotype DX requisition form and send it along with the specimen. Check with Customer Service to see if Oncotype DX is reimbursed in your local market. Acceptable forms of payment include credit card, bank wire transfer or money order. Pre-payment is required prior to the release of results.
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- Request that the pathologist retrieve and prepare the specimen for submission. Detailed instructions are provided with the specimen box. Genomic Health prefers to receive prepared unstained slides from the fixed paraffin-embedded tumor block.
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- Ship the specimen in the Oncotype DX specimen kit box to our centralized laboratory in Redwood City, California via our preferred courier, Federal Express, using the pre-printed shipping document and commercial invoice (required by U. S. customs). Genomic Health covers the shipping charges to send the specimen from your country to the United States.
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- Receive results usually within 7 to 10 days from the date the laboratory processing begins (provided that all information required has been included on the requisition form). Results are returned via online secure access and facsimile.
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For information regarding an Oncotype DX distributor in your local market, please contact Customer Service at or by calling +800 662 68973 or 001-650-569-2080.
Specimens are analyzed in the United States. To submit a specimen, a Customs Declaration is required for the specimen to be accepted into the United States. A sample Customs Declaration can be found here. Oncotype DX Specimen Kits comply with international packaging regulations for diagnostic specimens (IATA 650 Packaging Instruction). Please contact Customer Service at 001-650-569-2080 in advance to discuss any special requirements.
Order Supplies/Questions
Please contact Customer Service for any questions you may have when completing the Oncotype DX Requisition Form or how to submit a specimen:
For U.S. Customers:
Email: Customer Service
For International Customers:
Email:
Phone: +800 662 68973 or 001-650-569-2080
Does insurance cover the Oncotype DX assay?
Insurance coverage varies by plan for all medical services and benefits. The Oncotype DX Breast Cancer Assay for DCIS patients is the first clinically validated genomic assay that can help predict local recurrence in DCIS patients (for DCIS and/or invasive carcinoma) after local excision of DCIS, which helps guide treatment decision-making. Individualized coverage policies should be verified as the extent of coverage of each plan can differ.
In addition, Genomic Health offers the Genomic Access Program (GAP) to assist physicians, their staff and patients with the reimbursement process by performing benefits investigations, processing claims, providing support for prior authorizations and qualifying patients for financial assistance based on eligibility.
What steps are necessary?
Submitting a Sample
When submitting a DCIS sample for the Oncotype DX Breast Cancer Assay, please choose the one block with the greatest amount (cross sectional area) of the highest grade DCIS and the least amount of non-DCIS mammary epithelium (hyperplastic mammary epithelium, normal epithelium). Total mastectomy specimens are not appropriate samples for the DCIS Score. In rare cases the diagnostic needle core biopsy may have more DCIS (cross sectional area) than the excisional sample; if this is the case, then the needle core biopsy should be submitted.
All specimens must be labeled with S barcode labels from the Oncotype DX Specimen Collection and Transportation Kit Box for that patient.
While the Genomic Health laboratory can accept tumor blocks and unstained slides, blocks are preferred due to the frequent requirement for manual microdissection of the specimen consistent with clinical trial experience.
Click on the PDFs below for detailed pathology guidelines.
Oncotype DX Assay Requisition Form Instructions
When submitting an Oncotype DX Breast Cancer Assay sample, please fill out each section of the Requisition Form. The PDF below contains an example of a requisition form, including instructions for completion.
International Customers
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 made by entering valid credit card information on the Requisition Form or by wire transfer.
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 DX Specimen Kits comply with international packaging regulations for diagnostic specimens (IATA 650 Packaging Instruction). Please contact Customer Service at 001-650-569-2080 in advance to discuss any special requirements.
Below are ordering/sample submission instructions for international customers.
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- Contact Customer Service at to obtain specimen transportation kit boxes, requisition forms and pathology guidelines for preparation of samples. Kit boxes arrive within 3 to 5 business days.
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- Complete the Oncotype DX requisition form and send it along with the specimen. Check with Customer Service to see if Oncotype DX is reimbursed in your local market. Acceptable forms of payment include credit card, bank wire transfer or money order. Pre-payment is required prior to the release of results.
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- Request that the pathologist retrieve and prepare the specimen for submission. Detailed instructions are provided with the specimen box. Genomic Health prefers to receive prepared unstained slides from the fixed paraffin-embedded tumor block.
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- Ship the specimen in the Oncotype DX specimen kit box to our centralized laboratory in Redwood City, California via our preferred courier, Federal Express, using the pre-printed shipping document and commercial invoice (required by U. S. customs). Genomic Health covers the shipping charges to send the specimen from your country to the United States.
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- Receive results usually within 7 to 10 days from the date the laboratory processing begins (provided that all information required has been included on the requisition form). Results are returned via online secure access and facsimile.
|
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For information regarding an Oncotype DX distributor in your local market, please contact Customer Service at or by calling +800 662 68973 or 001-650-569-2080.
Specimens are analyzed in the United States. To submit a specimen, a Customs Declaration is required for the specimen to be accepted into the United States. A sample Customs Declaration can be found here. Oncotype DX Specimen Kits comply with international packaging regulations for diagnostic specimens (IATA 650 Packaging Instruction). Please contact Customer Service at 001-650-569-2080 in advance to discuss any special requirements.
If this is your first time filling out any of our forms, call 001-650-569-2080 for more detailed information.
Order Supplies/Questions
Please contact Customer Service for any questions you may have when completing the Oncotype DX Requisition Form or how to submit a specimen:
For U.S. Customers:
Email: Customer Service
Phone: 866-ONCOTYPE (866-662-6897)
For International Customers:
Email:
Phone: +800 662 68973 or 001-650-569-2080
How can I access reports?
Over 90% of Oncotype DX Assay results are available within 7 to 10 days from the date laboratory processing begins.
Reports can be delivered by fax or secure online access to the treating physician, submitting pathologist and/or other authorized healthcare providers.
In an effort to provide high-quality customer service and expedited turnaround time, Genomic Health offers online access to test results. This online service is free of charge and is available to all healthcare professionals who order the Oncotype DX Breast Cancer Assay.
If you are a new user of Genomic Health Online and do not have a User ID, or if you have forgotten your User ID or Password, please contact Customer Service at (866) ONCOTYPE (866-662-6897) or Customer Service
What information is available in the Oncotype DX assay report?
A detailed Oncotype DX DCIS Score report is generated for each patient, with assay results provided as a continuous DCIS Score result (0-100). The report also provides quantitative ER and PR single gene scores on the final page.
Click to view Sample Report
- What is the Oncotype DX® Breast Cancer Assay for DCIS?
- Has the DCIS Score™ been approved for use in the U.S.?
- Which patients are appropriate for the DCIS Score?
- When should the DCIS Score be used?
- How accurate are the results of the DCIS Score?
- Is the DCIS Score included in guidelines?
- How does the DCIS Score result correlate with a patient's likelihood of distant recurrence?
- How was the gene panel for the DCIS Score developed and validated?
- Can the DCIS score provide information about radiation benefit?
- How do I order the Oncotype DX Breast Cancer Assay for DCIS patients?
- What type of tumor sample is required for the DCIS Score?
- How much tumor tissue is required?
- How should international specimens be handled?
- Why do the Oncotype DX Breast Cancer Assay 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?
- Why is the HER2 Score not being reported?
- Is the DCIS Score same as the Recurrence Score (How is the DCIS Score different from the Recurrence Score?)
- Will you charge a different price for the DCIS Score?
- Does insurance cover the Oncotype DX Breast Cancer Assay for DCIS patients?
- Of the more than 45,000 DCIS patients diagnosed each year in the United States, what is the addressable patient population for the Oncotype DX Breast Cancer Assay for DCIS patients?
- What are the genes in the DCIS algorithm?
1. What is the Oncotype DX® Breast Cancer Assay for DCIS?
The Oncotype DX Breast Cancer Assay is the first clinically validated, genomic assay which provides DCIS patients with an individualized prediction of the 10-year risk of local recurrence (DCIS or invasive carcinoma) to help guide treatment decision making in women with ductal carcinoma in situ treated by local excision, with or without adjuvant tamoxifen therapy.
2. Has the DCIS Score™ been approved for use in the U.S.?
Prospective clinical validation of the DCIS Score was performed in collaboration with the Eastern Cooperative Oncology Group (ECOG) in patient DCIS tumor samples obtained from the multicenter E5194 DCIS trial. The results of the initial validation study of the DCIS Score in stage 0, DCIS patients, treated with local excision were presented at the San Antonio Breast Cancer Symposium in December, 2011 and will be published in the near future. The DCIS Score will be commercially available for women with DCIS treated by local excision alone by end of December, 2011.
The DCIS Score is calculated from quantitative RT-PCR gene assessments obtained from the Oncotype DX Breast Cancer Assay. The Oncotype DX Breast Cancer 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 Breast Cancer Assay is used for clinical purposes, and it should not be regarded as investigational or for research. Oncotype DX Breast Cancer Assay results are adjunctive to the ordering physician’s diagnostic evaluation of a patient with newly diagnosed early stage breast cancer.
3. Which patients are appropriate for the DCIS Score?
The DCIS Score is clinically validated for patients with newly diagnosed DCIS, who are treated with local excision alone, with or without adjuvant tamoxifen therapy.
4. When should the DCIS Score be used?
The DCIS Score can be ordered as soon as formalin fixed paraffin embedded (FPET) DCIS tumor tissue is available for submission to Genomic Health. The DCIS Score is intended for use in women newly diagnosed DCIS who are treated with local excision, with or without adjuvant tamoxifen therapy and provides information that may be used to help guide treatment planning.
5. How accurate are the results of the DCIS Score?
The DCIS Score is supported by extensive analytical studies and was clinically validated in E5194, an independent multicenter study with prospectively-defined endpoints. The results of the initial validation study of the DCIS Score in stage 0, DCIS patients, treated with local excision were presented at the San Antonio Breast Cancer Symposium in December, 2011 and will be published in the near future.
6. Is the DCIS Score included in guidelines?
The DCIS Score was just clinically validated and is not included in the ASCO® (American Society of Clinical Oncology®) or NCCN® (National Comprehensive Cancer Network®) guidelines.
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.
7. How does the DCIS Score result correlate with a patient's likelihood of distant recurrence?
The individual patient DCIS Score result is provided on a continuous scale that ranges from 0 to 100. The DCIS Score is calculated from quantitative RT-PCR gene assessments obtained from the Oncotype DX Breast Cancer Assay performed on patient DCIS FPET samples. For DCIS patients treated by local excision, with or without adjuvant tamoxifen therapy, the DCIS Score is associated with the likelihood of local recurrence (DCIS or invasive carcinoma), and predicts a specific likelihood of recurrence with the precision indicated with the 95% confidence intervals.
8. How was the gene panel for the DCIS Score developed and validated?
The Oncotype DX Breast Cancer Assay genes were selected by examining 250 candidate genes in three clinical studies. The DCIS Score is obtained by performing the Oncotype DX Breast Cancer Assay, using a distinct DCIS algorithm and coefficients that were pre-specified and designed to predict recurrence in patients with DCIS regardless of whether adjuvant tamoxifen therapy was given.
Development of the DCIS Score algorithm was based on presented results for Oncotype DX showing similarity in the expression profiles of the Recurrence Score genes between DCIS and Invasive Breast Cancer (IBC) when both are present within the same patient tumor. The DCIS Score algorithm was subsequently developed from published data obtained from the Kaiser Permanente and NSABP B-14 studies which identified genes that were found to predict distant recurrence regardless of whether adjuvant tamoxifen therapy was given.
The DCIS Score was validated, using prospectively-defined endpoints, in an independent clinical study of patient DCIS samples from the landmark ECOG E5194.
9. Can the DCIS score provide information about radiation benefit?
It is not known whether the DCIS Score predicts the relative benefit of radiation. However, since local recurrences are most often manageable, many physicians recommend surgery alone for patients with low recurrence risk.
10. How do I order the Oncotype DX Breast Cancer Assay for DCIS patients?
The same Oncotype DX Breast Cancer Assay that you have been ordering for invasive breast cancer is used to generate the DCIS Score. Please indicate that you are requesting the DCIS Score on the requisition form. Materials necessary for sample collection and submission are provided in the Oncotype® Specimen Kit, which can be ordered through Genomic Health. DCIS FPET tumor samples are submitted to the Genomic Health Laboratory for analysis using the Oncotype DX Breast Cancer Assay.
Click here for more information about ordering the assay.
11. What type of tumor sample is required for the DCIS Score?
The DCIS Score is performed using the Oncotype DX Breast Cancer Assay and fixed paraffin embedded DCIS tumor tissue is submitted, similar to the process that has been long used for submission of invasive breast cancer samples. DCIS tumor tissue obtained by local excision or core biopsy. Total mastectomy specimens are not appropriate samples. When submitting a DCIS tumor sample for the Oncotype DX Breast Cancer Assay, please choose the one block with the greatest amount (cross sectional area) of the highest grade DCIS and the least amount of non-DCIS mammary epithelium (hyperplastic mammary epithelium, normal epithelium).
12. How much tumor tissue is required?
The Oncotype DX Breast Cancer Assay requires 35 to 65 microns of FPET tumor tissue depending on the need for manual micro dissection. Fixed paraffin embedded tumor blocks are the preferred sample.
13. How should international specimens be handled?
Genomic Health is able to accept DCIS 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 DX 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.
14. Why do the Oncotype DX Breast Cancer 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 Breast Cancer 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 DCIS Score result, many physicians requested that the quantitative ER and PR Scores be reported together with the DCIS Score result as part of the Oncotype DX Breast Cancer Assay report to provide additional insight into the biology of individual tumors.
15. 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.
16. Why is the HER2 Score not being reported?
HER2 single gene results will not be reported due to the lack of randomized clinical trial data supporting its use as either a prognostic marker or as a marker of trastuzumab benefit in patients with DCIS.
17. Is the DCIS Score same as the Recurrence Score (How is the DCIS Score different from the Recurrence Score?)
The DCIS Score is obtained by performing the Oncotype DX Breast Cancer Assay using a pre-specified DCIS algorithm optimized to predict recurrence regardless of whether adjuvant tamoxifen therapy was given. Some of the coefficients were increased and some decreased to optimize for use in DCIS.
18. Will you charge a different price for the DCIS Score?
No. We are performing the Oncotype DX Breast Cancer Assay, and will charge the established price for it. As with the use of the Recurrence Score® in invasive breast cancer patients, the use of the DCIS Score in DCIS patients should prove to be cost effective or even cost saving. It will provide physicians and patients valuable information to help improve treatment decisions and avoid unnecessary treatment, in this case radiation.
19. Does insurance cover the Oncotype DX Breast Cancer Assay for DCIS patients?
Insurance coverage varies by plan for all medical services and benefits. The Oncotype DX Breast Cancer Assay for DCIS patients is the first clinically validated genomic assay that predicts the likelihood for local recurrence in DCIS patients (DCIS or invasive carcinoma) after local excision which helps guide treatment decision-making. Individualized coverage policies should be verified as the extent of coverage of each plan can differ. Genomic Health’s patient assistance program is prepared to assist with insurance verification and communicating insurance plans benefits to patients. They can also coordinate patient financial assistance for those who qualify.
20. Of the more than 45,000 DCIS patients diagnosed each year in the United States, what is the addressable patient population for the Oncotype DX Breast Cancer Assay for DCIS patients?
All women with DCIS treated by local excision, with or without tamoxifen.
21. What are the genes in the DCIS algorithm?
The genes used to calculate the DCIS Score are a subset of those assessed by the Oncotype DX Breast Cancer Assay.