Physicians FAQs About BBDRisk Dx™ Test
We have provided the answers for 13 physicians FAQs about BBDRisk Dx™
What is BBDRisk Dx™?
BBDRisk Dx™ is a genomic test that predicts the likelihood of breast cancer development in subjects who are diagnosed with precancerous growths which have one or more of the following histologies: Atypical Ductal Hyperplasia (ADH), Atypical Lobular Hyperplasia (ALH), Usual Ductal Hyperplasia (UDH), Papilloma or Sclerosing Adenosis.
The test assays the expression levels of several oncogenic protein markers, MMP-1, CEACAM6, HYAL1 and HEC1, that were discovered by gene expression studies and validated by immunohistochemistry in samples from over 500 patients with up to 19 years of clinical follow up information. The assay involves obtaining a sample of hyperplastic tissue, determining the levels of the above oncogenic markers, calculating the risk score using a proprietary algorithm and categorizing the patient as Low Risk, Intermediate Risk or Elevated (High) Risk for the likelihood of developing breast cancer. This is accomplished by comparing the patient’s risk score to a plurality of risk scores in Silbiotech’s database.
Is the BBDRisk Dx™ test performed in a CLIA approved laboratory in the U.S.?
Yes. Our laboratory is approved under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing of BBDRisk Dx™ (CLIA #21D2137469). The BBDRisk Dx™ test is used for clinical purposes, and should not be regarded as investigational or for research.
Which patients are appropriate for the BBDRisk Dx™ test?
The BBDRisk Dx™ test is appropriate for subjects who have been diagnosed with precancerous growths that have one or more of the following histologies:
- Atypical Ductal Hyperplasia (ADH),
- Atypical Lobular Hyperplasia (ALH),
- Usual Ductal Hyperplasia (UDH),
- Sclerosing Adenosis
- Any combination of the above
However, the BBDRisk Dx™ test is not suitable for fibroadenomas with or without hyperplasia unless the hyperplastic ducts are present outside of the fibroadenoma.
Is there a time limitation after diagnosis to order the BBDRisk Dx™ test?
No. The BBDRisk Dx™ test can be ordered any time after resected hyperplastic tumor tissue is available (see Test Order form for instructions). The test provides information that may be used for planning the course of disease management, therefore, it is recommended that the BBDRisk Dx™ be ordered soon after the histological diagnosis of the tumor is obtained and before any medical management decisions are made.
How was the gene panel for the BBDRisk Dx™ test developed and validated?
The identification of the gene panel for the BBDRisk Dx™ test started with gene expression analysis of ADH tissues from patients who subsequently developed (DCIS, LCIS or invasive) cancer (after a minimum of one year) in comparison with ADH from patients who did not have prior breast cancer and did not develop cancer after a minimum of five years. This allowed the identification of over 300 genes associated with breast cancer development. The results of these studies were used to develop a multiple oncogenic protein marker test which consistently correlated with cancer development. The data from these studies were published in very high impact medical journals (Nature Medicine 2005, PMID: 15864312, Clinical Cancer Research 2006, PMID: 16899629 and Clinical Cancer Research 2008, PMID: 18281563). The multiple marker BBDRisk Dx™ test algorithm was then developed and validated using an independent clinical study of hyperplastic tumor samples from over 500 patients with up to 19 years of clinical follow up information.
How do I order the BBDRisk Dx™ test?
Upon request by email, Silbiotech, Inc. will provide Sample Kits for you to ship the specimens. Guidelines necessary for sample collection and submission of the BBDRisk™ Dx test Requisition Form can be downloaded from the website in the Physician section (click the form links and use the Browser’s File Save As to save the forms)
More Answers To Physicians FAQs About BBDRisk Dx™ Test
What type of tumor sample is required for the BBDRisk Dx™ test?
The BBDRisk Dx™ test is performed on slides prepared from the formalin-fixed, paraffin-embedded tumor biopsy tissue sample which is available in the Pathology Department of the institution where the biopsy was performed.
What is the tumor tissue requirement?
In compliance with CLIA regulations, the BBDRisk Dx™ test requires unstained slides from a tumor block that was used for diagnosis, and an H&E slide from the same block. When blocks are submitted, typically 35 to 65 microns of tissue will be used. If slides are submitted, six unstained slides along with an H&E slide is required. If residual atypia is limited in the block from which the diagnosis was made, slides can be cut from more than one block. If the tumor tissue has multiple histologies, the block or slides submitted should best represent the most histologies. Fibroademonas with or without hyperplasias are not acceptable. However, blocks that have hyperplastic ducts outside of fibroadenomas can be submitted (click the form links and use the Browser’s File Save As to save the forms)
How are the results of the BBDRisk Dx™ test reported?
The results of the BBDRisk Dx™ test are reported as a ‘Cancer Risk Score’ from 0-10 (please see the Sample BBDRisk Dx™ Test Report) (click the form links and use the Browser’s File Save As to save the form). The higher the risk score, the higher one’s risk of developing breast cancer. In addition, it categorizes the patient as ‘Low Risk’, ‘Intermediate Risk’ or ‘Elevated (High) Risk’ by comparing the patient’s risk score with the plurality of risk scores in Silbiotech’s data base. The test Results Report will also provide an overview of the clinical validation study which correlates the Risk Score to the ‘Cancer Free Rate or Cancer Rate’ among subjects who have a similar ‘Risk Score’ The test results report itself is sent by mail, fax or email.
What is the turnaround time for the BBDRisk Dx™ test results?
The BBDRisk Dx™ test results will be reported about one to two weeks after receipt of the specimen.
Is the BBDRisk Dx™ test currently available?
Yes. The BBDRisk Dx™ test is available and Silbiotech, Inc. is currently accepting patient samples.
Is the BBDRisk Dx™ test covered by health insurance?
BBDRisk Dx coverage is approved by Center for Medicare, Medicaid (CMS) and major private insurance agencies. We will bill the patient’s insurance company directly. Based on the patient’s specific benefit level, the insurance company may pay a portion or all of the cost of the test. The patient will be responsible for any co-insurance, co-pay, or deductible expenditure as per the terms of the patient’s health insurance plan. We will work with patients and their insurance agencies to find out their specific coverage details. If the insurance carrier does not cover some or all of the cost of the test, we will work with the patients to set up an alternate payment plan. For international patients, payment is required prior to processing as an international money order in U.S. dollars along with the order form.
How should international specimens be handled?
Silbiotech, Inc accepts specimens from outside the U.S. for the BBDRisk Dx™ test. In addition to all other specimen requirements, payment is required prior to processing as 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 down-loaded from the website (click the form links and use the Browser’s File Save As to save the forms). BBDRisk Dx™ Specimen Kits comply with international packaging regulations for diagnostic specimens (IATA 650 Packaging Instruction). Please contact us in advance to discuss any special requirements.