Physicians FAQs About BBDRisk Dx® Test

We have provided the answers for FAQs about the BBDRisk Dx® Test below.

What is BBDRisk Dx®?

BBDRisk Dx® is a genomic test that predicts the likelihood of breast cancer development in subjects who are diagnosed with masses that 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 four oncogenic protein markers, MMP-1, CEACAM6, HYAL1 and HEC1, which were discovered by gene expression studies and validated by immunohistochemistry in 550 patient samples with up to 19 years of clinical follow up information. The assay involves obtaining FFPE sample slides 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 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 masses that have one or more of the following histologies:

  • Atypical Ductal Hyperplasia (ADH),
  • Atypical Lobular Hyperplasia (ALH),
  • Usual Ductal Hyperplasia (UDH),
  • Papilloma,
  • 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 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® test be ordered soon after the histological diagnosis is obtained and before any medical treatment 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 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 for a minimum of five years. This allowed the identification of over 300 genes associated with breast cancer development (Nature Medicine 2005, PMID: 15864312). Selected individual markers identified from the gene expression study were validated in clinical samples (n=105-180) and their expressions consistently correlated with cancer development (Nature Medicine 2005, PMID: 15864312, Clinical Cancer Research 2006, PMID: 16899629 and Clinical Cancer Research 2008, PMID: 18281563). A multimarker BBDRisk Dx® test algorithm was then developed and validated in an independent set of clinical samples (n=440) with up to 19 years clinical follow up information (Cancer Prevention Research 2019, PMID: 31239263).

The following publications are the scientific basis for BBDRisk Dx® Test development. See also the section Science Behind BBDRisk Dx® Test Development under the BBDRisk Dx® tab.

Cancer Prevention Research 2019

Clinical Cancer Research 2008

Clinical Cancer Research 2006

Nature Medicine 2005

How do I order the BBDRisk Dx® test?

Email the BBDRisk® Dx test request form to [email protected] along with the patient’s insurance information (a request form and a sample of a completed request form can be downloaded here). You can also fax the orders to: 301-987-9724. You can either request the pathologist to mail us the six unstained tissue sections on charged slides along with the pathology report or provide us the pathologist’s contact information so that we can make the request.

What type of Tissue sample is required for the BBDRisk Dx® test?

The BBDRisk Dx® test is performed on slides prepared from the formalin-fixed, paraffin-embedded biopsy tissue sample which is available in the Pathology Department of the institution where the biopsy was performed.

What is the tissue requirement?

In compliance with CLIA regulations, the BBDRisk Dx® test requires six unstained tissue slides from a block that was used for diagnosis, and an H&E slide from the same block. 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 tissue has multiple histologies, the slides submitted should best represent the most histologies. Fibroademonas with or without hyperplasias are not acceptable. However, tissue sections that have hyperplastic ducts outside of fibroadenomas can be submitted.

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 Results Reports) 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 ‘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 fax or email.

What is the turnaround time for the BBDRisk Dx® test results?

The BBDRisk Dx® test results will be reported about two to three weeks after receipt of the specimen.

Is the BBDRisk Dx® test currently available?

Yes. The BBDRisk Dx® test has been available since June of 2019. Thus far hundreds of test orders have been received from physicians from all over the USA.

Is the BBDRisk Dx® test covered by health insurance?

BBDRisk Dx® Test cost is $4,500 and is currently covered by Medicare, most Medicare Advantage plans, UnitedHealthCare and several other commercial insurance agencies. We will bill the patient’s insurance company directly. We will work with the patient and the patient’s insurance agency to receive the maximum allowable coverage. The patients will be billed for any deductible and copays according to their insurance plans.

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. 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.