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Breast Cancer Index Test Price

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Mary Discusses her Breast Cancer Index Test Results and Life After

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  • How Long Does It Take For Copays To Pile Up After Breast Cancer Diagnosis

    Deductibles, co-pays, and co- insurance pile up in the first 2-3 months after diagnosis, before you hit your out-of-pocket maximum. The best way to deal with the costs of breast cancer treatment is to address them head-on. Learn as much as you can about what expenses youll have and plan carefully for them.

    Study Population And Tumor Samples

    Patients were identified by a search of the Cancer Registry Data at the UPMC University of Pittsburgh Cancer Institute, a large database that includes comprehensive demographic and clinical outcome data on patients with breast cancer. Eligible patients included all subjects who had ER+ , LN- invasive breast cancer diagnosed between 1990 and 1999 and who had received adjuvant tamoxifen. In addition, patients were included in the study only if there was an associated formalin-fixed, paraffin-embedded tissue block from the time of original diagnosis in order to confirm ER status and tumor grade. This study was approved by the Institutional Review Board at the University of Pittsburgh. In accordance with the approval, informed consent from the patients was not required.

    A hematoxylin and eosin slide for each case was reviewed to confirm tumor grade by using the Nottingham grading system to include tubules, nuclear grade, and mitosis. To confirm ER status, one representative tumor block was selected for immunohistochemistry analysis. IHC was performed on the selected FFPE tissue blocks with pre-dilute rabbit monoclonal antibodies directed against ER alpha , and the recommended protocols of the manufacturers were followed as specified. A tumor was considered ‘ER-positive’ if there were 10% or more ‘nuclear’ staining of the tumor cells.

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    What Do The Results Of The Breast Cancer Index Test Mean

    Suppose your test results show a high risk of your cancer returning.

    In that case, it may mean that you could benefit from continuing hormone therapy.

    If your results show a low risk of your cancer returning, it may mean that you could safely stop taking hormone therapy.

    Your doctor can help you interpret your results and make an informed decision about your treatment.

    How Is Breast Cancer Staging Determined

    Breast Cancer Screening Test Market

    Clinical staging is based on the results of tests done before surgery, which may include physical examinations, mammogram, ultrasound, and MRI scans. Pathological staging is based on what is found during surgery to remove breast tissue and lymph nodes. The results are usually available several days after surgery.

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    What Do The Results Of Hormone Testing Mean

    Breast cancer patients who test positive for both estrogen receptors and progesterone receptors usually have a better-than-average prognosis for survival and a complete recovery than those who have no receptors present. Also, the more receptors and the more intense their reaction, the better they respond to hormone therapy. Patients with one type of receptor but not the other may still reap benefits from this form of treatment, but likely not to the same degree. As mentioned earlier, if the cancer is both ER- and PR-negative, it probably wont respond to hormone therapy. Typical response rates to hormone therapy are as follows:

    • ER and PR positive: 75-80%
    • ER positive and PR negative: 40-50%
    • ER negative and PR positive: 25-30%
    • ER negative and PR negative: 10% or less

    How Does The Test Work

    The testing lab typically uses a specialized staining process on the breast tissue sample to see if hormone receptors are present. The technical name for this procedure is an immunohistochemical staining assay or an ImmunoHistoChemistry . Findings will be included in a pathology report given to your doctor. If the cancer is deemed estrogen-receptor-positive , its cells have receptors for the estrogen hormone. That means that the cancer cells likely receive signals from estrogen to promote growth. About two out of every three breast cancers contain hormone receptors.

    If the cancer is progesterone-receptor-positive , its cells have receptors for progesterone. This hormone could then promote the growth of the cancer.

    The cancer cells being estrogen and/or progesterone receptor-positive is a good prognostic factor to have, usually leading to a better prognosis.

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    Pilot Study Comparing Laser Capture Microdissection With Standard Macro

    To determine the analytical impact of tissue stroma and further define sample requirements based on cellularity, 23 tumor samples were analyzed in a pilot study comparing tissue processing by either the standard manual macro-dissection or laser capture micro-dissection . It was hypothesized that LCM would enrich for invasive tumors cells, thus impacting BCI results. Pre-specified criteria to determine equivalence between dissection methods were based on an empirically defined 80% concordance using the BCI assay variability threshold of two SDs of BCI score difference .

    What Is A Her2 Receptor And How Does It Relate To Breast Cancer

    Pros and cons of new low cost genetic test for breast cancer

    Healthy HER2 receptors are the proteins that help manage how a breast cell grows, divides, and repairs itself. However, in about a quarter of all breast cancer patients, the HER2 gene isnt functioning properly. It makes an excess number of copies of itself in a process known as HER2 gene amplification. Then these extra genes instruct the cells to make too many HER2 receptors, which is called HER2 protein overexpression. The ultimate result is that breast cells grow and divide in an uncontrolled fashion.

    The HER2/neu test can discover whether the sample is normal or whether it has too much of the HER2/neu protein or an excessive number of copies of its gene. If you have been diagnosed with invasive breast cancer or have had recurrent breast cancer, your doctor may recommend this test. It will help your oncology team determine your prognosis, characteristics of the tumor including how aggressive the tumor is likely to be, and the best treatment options.

    This test is often ordered in conjunction with the hormone receptor test. Typically, the breast cancer tissue sample from a biopsy or the tumor removed during a mastectomy is used. This test can take about a week to get the pathology results back, whereas determining if the cells are cancer usually is known in just a day or two.

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    Who Needs Hormone Receptor Testing

    Hormone receptor testing is generally recommended for all breast cancers, including DCIS. If your doctor orders this test, you may be asked to discontinue taking any prescribed hormones for a period of time before the breast tissue sample is obtained. Usually, the sample comes from a biopsy, but the test may also be performed on tissue removed during a lumpectomy or mastectomy. It is standard of care however to obtain these types of pathology results on biopsy tissue.

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    Study Design And Patient Samples

    In this retrospective study, formalin-fixed paraffin-embedded tumor specimens from 376 patients diagnosed with ILC between 1992 and 2011 were collected from The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University , Dana-Farber Cancer Institute , Massachusetts General Hospital , and the Pitt Biospecimen Core at the University of Pittsburgh and University of Pittsburgh Medical Center Magee-Womens Hospital . Inclusion criteria included HR+ based on ASCO/CAP guidelines ref. ), stage I to III based on AJCC 7th Ed. , any nodal status, and pure lobular or mixed lobular/ductal histology. HER2 status was determined according to standard procedures at the time of patient diagnosis by IHC and FISH analysis. Patients were excluded if treated with neoadjuvant therapy, missing clinical information , or inadequate survival follow-up.

    Nccn Now Recommends Breast Cancer Index For Predicting Benefit From Extended Endocrine Therapy

    Testing for HER2

    The Breast Cancer Index assay is the only of its kind to be recommended in the National Comprehensive Cancer Network Guidelines for the treatment of breast cancer as being predictive of extended adjuvant endocrine therapy.

    Breast Cancer Index , a molecular gene expressionbased test used for determining which patients with early-stage, hormone receptor positive breast cancer benefit from extended endocrine therapy, is now included in the National Comprehensive Cancer Network Guidelines for breast cancer, according to Biotheranostics, Inc.1

    Per NCCN recommendations, BCI can be used for consideration of extended adjuvant endocrine therapy with a 2A category of evidence and consensus, which indicates uniform consensus from the organization that the recommendation is appropriate.

    Clinical guideline endorsement by the NCCN Panel marks an evidentiary milestone for the Breast Cancer Index underscoring its distinct clinical utility for women with HR early-stage breast cancer, and a new paradigm for the use of genomic assays to aid in endocrine decision-making, Catherine Schnabel, PhD, chief scientific officer of Biotheranostics, stated in a press release.With NCCN Guidelines as the recognized benchmark for cancer policy, the positive recommendation of BCI as a predictive biomarker of extended endocrine benefit will allow increased patient access to this important genomic tool.

    References:

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    Prognostic Utility Of Breast Cancer Index To Stratify Distant Recurrence Risk In Invasive Lobular Carcinoma

    Corresponding Author:

    R. Nunes and T. Sella contributed equally to this article.

    Corresponding Author:

    • UPMC Hillman Cancer Center and Tissue and Research Pathology

    Clin Cancer Res

  • Accepted Manuscript August 10 2021
  • Raquel Nunes, Tal Sella, Kai Treuner, Jennifer M. Atkinson, Jenna Wong, Yi Zhang, Pedro Exman, David Dabbs, Andrea L. Richardson, Catherine A. Schnabel, Dennis C. Sgroi, Steffi Oesterreich, Ashley Cimino-Mathews, Otto Metzger Prognostic Utility of Breast Cancer Index to Stratify Distant Recurrence Risk in Invasive Lobular Carcinoma. Clin Cancer Res 15 October 2021 27 : 56885696.

    Breast Cancer Index May Predict Benefit Of Extended Endocrine Therapy In Certain Patients With Hormone Receptorpositive Disease

    12/22/2021 3:18:35 PM

    New data were presented at the 2021 San Antonio Breast Cancer Symposium demonstrating that the Breast Cancer Index may predict preferential recurrence-prevention benefit from extended endocrine therapy and may also predict the overall benefit/risk and likelihood of improved health outcomes from extended endocrine therapy in certain patients with hormone receptorpositive breast cancer. A second study also confirmed that the two biomarkers used in BCI are interconnected molecular drivers of assessing recurrences in hormone receptorpositive breast cancer. These findings were presented in Spotlight Sessions at the Symposium.

    Breast Cancer Index is a gene expressionbased test that provides information to help physicians individualize treatment decisions for patients with early-stage, hormone receptorpositive breast cancer. The test helps oncologists and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment.

    Prediction of Net Treatment Benefit of Extended Endocrine Therapy

    Biomarkers Independently Contribute to Ability to Predict Extended Endocrine Therapy Benefit

    The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. and does not necessarily reflect the ideas and opinions of ASCO®.

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    What Are Genomic Tests

    Genomic tests analyze a sample of a cancer tumor to see how active certain genes are. The activity level of these genes affects the behavior of the cancer, including how likely it is to grow and spread. Genomic tests are used to help make decisions about whether more treatments after surgery would be beneficial.

    How Long Does It Take For Breast Cancer To Come Back

    Medicare Insurance Coverage for Breast Cancer Index Test

    The Breast Cancer Index test, made by Biotheranostics, analyzes the activity of seven genes to help predict the risk of node-negative, hormone-receptor-positive breast cancer coming back 5 to 10 years after diagnosis. The test can help women and their doctors decide if extending hormonal therapy 5 more years

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    Does Medicaid Cover Genetic Testing For Breast Cancer

    Medicaid covers genetic testing for breast cancer in all states except three. Those three states are:

    These three states do not cover the cost of genetic testing for hereditary cancer risk.

    Multigene panel testing is not covered by most Medicaid programs.

    Despite Medicaid covering breast cancer genetic testing cost more than Medicare and many health insurance providers, there is still a testing eligibility criteria. This eligibility criterion does differ by state. Genetic counselors help people understand if they meet the Medicaid guidelines for genetic testing in their state.

    What Is The Breast Cancer Index Test

    The Breast Cancer Index test is performed on preserved tissue that was removed during the original biopsy or surgery. Because many women have troubling side effects, including hot flashes and joint pain, from hormonal therapy, they want to know if extending the time they take hormonal therapy is worth tolerating the side effects.

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    Breast Cancer Index Test Cost

    The cost of a breast cancer index test will vary depending on several factors, including:

    • The type of breast cancer index test thats performed
    • The geographic location of the testing center
    • Type of insurance coverage you have

    Without insurance, the price of the breast cancer index test can range from $3,000 to $6,000.

    Comparison Of Breast Cancer Index With Adjuvant Online

    Breast Cancer CA15

    Univariate Cox models were fit separately for both BCI and AO. AO was significantly associated with risk of recurrence , all-cause mortality , and breast cancer-specific mortality . BCI was also significantly associated with risk of recurrence , all-cause mortality , and breast cancer-specific mortality . A combined multivariate analysis with only BCI and AO showed that both independently remained significantly associated with risk of recurrence ,3), all-cause mortality ,4), and breast cancer-specific mortality .

    To determine the accuracy of risk assessment by BCI and AO over the course of a 10-year period, we completed a global concordance summary, which is a measure of agreement between survival time and predicted risk over the course of a 10-year period of follow-up . The concordance measure estimates the probability that, for two randomly chosen individuals, the subject with the shorter survival time also has the larger risk score. A model with perfect agreement would have a value close to 1, whereas a value of 0.5 is no better than chance. For time to distant recurrence for all patients, iAUC values were 0.642 for models with AO only and 0.717 for models with AO+BCI. For the patients treated with tamoxifen alone, these probability values increased to an iAUC of 0.671 and 0.750 for models with AO only and AO+BCI, respectively.

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    What To Do About The Breast Cancer Genetic Testing Cost

    What many people do not know is that breast cancer genetic testing cost is not thousands of dollars. It can actually be quite affordable at about $400.

    Genetic testing laboratories do not want the general population to know that testing is much less than they pay or the insurance companies are charged because its a huge money-making industry. The reality is that the DNA test needed to have the raw data analyzed for BRCA1, BRCA2, and many other cancer-related gene mutations can cost just $399 and accessed online.

    Sequencing.com has an Ultimate Whole Genome Sequencing test service sequences BRCA1, BRCA2, as well as 20,0000 other genes. This provides more comprehensive and accurate test results, leading to a higher level of knowledge for cancer risk.

    Will insurance companies, Medicare, Medicaid, and the Affordable Care Act pay for the Ultimate Whole Genome Sequencing test service? No. However, due to the breast cancer genetic testing cost being so low, most people do not need financial assistance.

    Learn More: At Home Genetic Testing for Breast Cancer

    Multigene Panel Testing For Inherited Genetic Mutations

    A multigene panel is a genetic test that identifies inherited mutations in more than one gene. It looks at BRCA1 and BRCA2 mutations along with mutations in genes such as PALB2, CHEK2, etc. Medicare will cover breast cancer genetic testing cost for a multigene panel if:

    • A genetic counselor is not associated with a testing laboratory and recommends the testing.
    • The person has a genetic counseling appointment after the test has been performed for follow-up.
    • The genetic test results will affect their cancer treatment.
    • The genes are relevant to their personal and/or family history.
    • The person meets at least one of the criteria for hereditary cancer syndrome.

    A risk assessment must be conducted by a genetics counselor who is not associated with a testing laboratory. This assessment should consider the lifetime risk of developing breast and other types of cancer.

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