Frequently Asked Questions

Frequently Asked Questions About Breast Cancer IndexSM (BCI)

  • Breast Cancer Index is a test that provides individualized information to help patients and physicians make difficult decisions about extending anti-estrogen (also called hormonal or endocrine) therapy beyond 5 years for estrogen receptor-positive (ER+) early stage breast cancer patients.
  • Breast Cancer Index (BCI) combines two tests into one, and provides reports two pieces of information about the level of risk that your cancer will return after 5 years and if anti-estrogen medication is likely to help to prevent it from reoccurring based on the biology of your tumor.
    • BCI Prognostic provides an individualized risk of recurrence (defined as a recurrence between years 5 and 10 after your initial diagnosis) presented as a percentage [e.g., 3.2% or 7.5%] and a risk category [HIGH or LOW] for women who were lymph node negative at diagnosis. Positive lymph node status (LN+) increases risk, and LN+ patients should be considered at high risk of recurrence.14
    • BCI Predictive (sometimes called H over I, written as H/I) provides a likelihood of benefit from extended (>5 year) anti-estrogen therapy in women who are recurrence-free after an initial 5 years of anti-estrogen therapy. This is reported as HIGH Likelihood or LOW Likelihood
  • Breast Cancer Index (BCI) combines two complementary gene-expression signatures, looking at a total of 11 genes:
    • BCI Prognostic consists of 5 genes that assess proliferation (BUB1B, CENPA, NEK2, RACGAP1, RRM2) and 2 genes that assess the estrogen signaling pathway (ratio of HOXB13 and IL17BR)
    • BCI Predictive evaluates only the 2 genes that assess the estrogen signaling pathway (ratio of HOXB13 and IL17BR)
    • 4 control genes are also included in the assay
  • Breast Cancer Index has no overlapping genes with OncotypeDx® - a test you may have had to inform your likelihood of benefitting from chemotherapy
  • Not every woman treated with anti-estrogen treatment will have the same benefit from 5 additional years of therapy. In clinical trials, approximately 3-5 of every 100 women treated benefitted from extending anti-estrogen therapies beyond 5 years. Some women experienced significant side effects from treatment and exposure to long term risks from these medications. Breast Cancer Index helps to identify women that may be more likely to benefit from extending therapy beyond year 5, and also helps to identify women who are not likely to benefit from extended endocrine therapy, and thus may be spared the side effects from continuing therapy with these drugs.15-18 Your physician will use this in combination with additional clinical information to help determine your treatment path
  • Breast Cancer Index (BCI) is a test to provide information about your likelihood of benefitting from an additional 5 years of daily anti-estrogen medication. There is a different test that provides information about likelihood of benefitting from chemotherapy and it analyzes different genes.
  • Only Breast Cancer Index has been validated scientifically to predict the likelihood of benefit from anti-estrogen therapy beyond 5 years.
  • 3 clinical studies published in top-tier peer-reviewed journals have consistently demonstrated the ability of Breast Cancer Index Prognostic to separate patients with a low risk or high risk of recurrence. For example, a well-respected, international, long-term clinical trial (TransATAC) identified 59% of patients who have a low risk of recurrence between years 5 to 10 following diagnosis.
  • Additionally, 3 other clinical studies have consistently demonstrated the ability of Breast Cancer Index Predictive to predict a woman’s likelihood to benefit from anti-estrogen therapy. For example, in another well-regarded long-term study (MA.-17) Breast Cancer Index identified a group of patients that derived no statistically significant benefit from extending treatment from 5 to 10 years. Across studies, approximately 55 %of patients are classified as highlow likelihood of benefit from extended endocrine therapy
  • You may be a candidate for Breast Cancer Index if:
    1. You have been diagnosed with stage I or IIa invasive breast cancer
    2. Your breast cancer is estrogen-receptor positive (ER+)
    3. You have been prescribed anti-estrogen (also called hormonal or endocrine) therapy
  • The decision whether or not to order Breast Cancer Index is one that you and doctor may make together
  • Breast Cancer Index testing does not require any additional procedures. After your doctor orders Breast Cancer Index, bioTheranostics reaches out to the hospital to collect the tumor specimen that was taken during your surgery. No additional procedure (no new blood or tissue) is required for Breast Cancer Index testing. After bioTheranostics receives the specimen, a result is returned to your doctor within 5-7 business days.
  • It may be appropriate to talk to your doctor about Breast Cancer Index whenever you have a question about how long you will need to take anti-hormonal therapy.
  • Although Breast Cancer Index is only ordered once per patient, your physician may order at various time points along your continuum of care:
    1. Around the time of your initial diagnosis to help provide clarity regarding the recommended duration of your anti-estrogen therapy (5 or 10 years)
    2. Approaching the 5 year anniversary (~4-5 years post-diagnosis) to further help inform whether to extend or end anti-estrogen treatment beyond 5 years
    3. Between years 5-9 post-diagnosis to provide additional information beyond what was available when the decision was originally made related to extended anti-estrogen treatment.
  • Two different test results are reported for Breast Cancer Index. There is a "Prognostic" result, which gives the risk of recurrence between years 5-10, and there is a "Predictive" result, which provides likelihood of benefit from extended endocrine therapy (beyond 5 years).
  • This permits 4 general test result possibilities for risk of recurrence beyond year 5 and likelihood of benefit from anti-estrogen therapy beyond year 5:
    • Low Risk of Late Recurrence/Low Likelihood of Benefit from Extended Anti-Estrogen Therapy test result occurs about 45% of the time
    • High Risk of Late Recurrence /High Likelihood of Benefit from Extended Anti-Estrogen Therapy test result occurs about 30% of the time
    • High Risk of Late Recurrence /Low Likelihood of Benefit from Extended Anti-Estrogen Therapy test result occurs about 15% of the time
    • Low Risk of Late Recurrence /High Likelihood of Benefit from Extended Anti-Estrogen Therapy test result occurs about 10% of the time
    • These percentages are based on data on file at bioTheranostics
    • Positive lymph node status (LN+) increases risk, and LN+ patients should be considered at high risk of recurrence.14
  • Breast Cancer Index is a covered benefit by Medicare.

    Click here for detailed information on certain coverage limitations.

  • Many commercial insurance plans will reimburse for Breast Cancer Index. We bill the plan directly after the test is run and a member from our Patient Advocate Team will contact you via mail and phone to inform you of the insurance process. At this point we also encourage you to apply to our access program which helps manage out of pocket expenses related to Breast Cancer Index. Many women who have been tested with Breast Cancer Index qualify for the program based on income and expenses, and owe nothing for the test.