Patients FAQs about BBDRisk Dx™ Test

The Most-Asked Patients FAQs About BBDRisk Dx™ Test are answered here.

1. Who should get the BBDRisk Dx™ Breast Cancer Risk Test?

BBDRisk Dx™ is a unique genomic test developed to help women who are diagnosed with precancerous breast tumors. You are eligible for BBDRisk Dx™ testing if the diagnosis of your suspected breast tumor or a lump demonstrated to have one or more of the following: Atypical Ductal Hyperplasia (ADH), Atypical Lobular Hyperplasia (ALH), Usual Ductal Hyperplasia (UDH), Papilloma, or Sclerosing Adenosis. The BBDRisk Dx™ test is intended to assess your level of risk for breast cancer development in the next 5 years.

2. How can I order the BBDRisk Dx™ Breast Cancer Risk Test?

You do not have to undergo additional procedures to have the BBDRisk Dx™. The BBDRisk Dx™ test is performed on a small amount of tissue that was previously removed during the biopsy of your suspected tumor and is available in the Pathology Department of the institution where your biopsy was done. The BBDRisk Dx™ test can be ordered by either your primary care physician, the surgeon who performed your biopsy, a gynecologist, or a clinical oncologist. You can ask your doctor to order the BBDRisk Dx™Test. We can assist your doctor in ordering the test.

3. When should BBDRisk Dx™ Test be ordered?

The BBDRisk Dx™ test can be ordered at any time after receiving the diagnosis of your suspected tumor as having one or more of the following: atypia, usual hyperplasia, papilloma or sclerosing adenosis. However, it is recommended that you order the test to understand your personalized risk level before you and your healthcare provider discuss and consider all the options in medical management of your breast disease.

4. Will my insurance cover the cost of the test?

BBDRisk Dx Test coverage has been approved by Medicare, Medicaid, and major private insurance agencies. We will bill your insurance company directly. Based on your specific benefit level, the insurance company may pay a portion or all of the cost of the test. You may be responsible for any co-insurance, copay, or deductible expenditure as per the terms of your health insurance plan. We will work with you and your insurance agency to find out your specific coverage details. If your insurance carrier does not cover some or all of the cost of the test, we will work with you to set up an alternate payment plan. For international orders, payment is required in the form of an international money order in U.S. dollars prior to processing.

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5. How long does it take to get the results?

We will provide the Test results within 1-2 weeks of receiving the tumor tissue sample from your healthcare provider. The BBDRisk Dx™ test report will be sent to the healthcare provider who signed the order form.

6. What is the difference between the BBDRisk Dx™ Test and other Tests (e.g BRCA1 and BRCA2 mutation screening, Oncotype Dx, DCISionRT, and MammaPrint)?

BBDRisk Dx™ is a novel genomic test for individuals who are diagnosed with an abnormality that indicates that they are at increased breast cancer risk. These diagnoses include Atypical Ductal Hyperplasia (ADH), Atypical Lobular Hyperplasia (ALH), Usual Ductal Hyperplasia (UDH), Papillomas, Sclerosing Adenosis or a combination of any of these types. The BBDRisk Dx™ test is performed to personalize one’s risk level for developing breast cancer. BRCA1 and BRCA2 testing is for individuals who have a strong family history of breast cancer to determine if they carry specific mutations in these genes which puts them at a higher risk for breast cancer. BRCA1 and BRCA2 testing is performed on a sample of blood. Genomic tests such as Oncotype Dx, DCISionRT, and MammaPrint determine the specific gene characteristics in the tumors of individuals who have already developed breast cancer and help determine if an individual should receive chemotherapy or radiation. The BBDRisk Dx™ test is the only test currently available that assesses the risk of breast cancer development in patients diagnosed with atypical or above mentioned benign tumors which have not yet developed into cancer.

7. What will the BBDRisk Dx™ test results show?

Your doctor would have already told you that you fall in the category of increased risk of developing breast cancer because your breast tumor has one or more of the following: ADH, ALH, UDH, Papillomas or Sclerosing Adenosis. The BBDRisk Dx™ is a multi-marker test performed on your tumor tissue to assess your risk of developing breast cancer in the future. The BBDRisk Dx™ test results will indicate whether you fall in the Low Risk, Intermediate Risk or Elevated (High) Risk category for breast cancer – important information when deciding on your options for prevention. By looking at the biological make up of your tumor, the BBDRisk Dx™ test result adds information beyond traditional factors such as age, family history and type of tumor. Silbiotech, Inc,’s BBDRisk Dx™ test validation has shown that a Low Risk result was an excellent indicator of being cancer free for 5-10 years. Patients with an Intermediate Risk had a 90% cancer free rate at 5 years. An elevated or High Risk result showed a 50% chance of breast cancer development within 5 years and 70% chance at 10 years. These results are based on a clinical study of samples from over 500 patients with more than 15 years of clinical follow up information on their cancer diagnosis or cancer free status.

Note: A Low Risk result does not guarantee that you will not develop breast cancer. An Elevated (High) Risk or Intermediate Risk result does not guarantee that you will develop cancer. These results, in addition to all other factors, will help you and your health care provider make the most informed decision on managing your breast disease.

8. Will the BBDRisk Dx™ test results tell my doctor which treatment to use?

The results of BBDRisk Dx™ test can help your healthcare provider understand the likelihood of you developing cancer but the results will not specifically identify which treatment to use to prevent breast cancer. The results of the BBDRisk Dx™ test should be used with other information about your health and other findings to help you and your healthcare provider decide whether you require any treatments.