What Is BBDrisk Dx® Test, Its Benefits And Need?
BBDRisk Dx® is a novel cancer protein marker test for women who are diagnosed with the following types of breast masses: Atypical Ductal Hyperplasias (ADH), Atypical Lobular Hyperplasias (ALH), Usual Ductal Hyperplasia (UDH), Papilloma, Sclerosing Adenosis or any combination of the above types. The test predicts the likelihood of developing breast cancer with ~ 91% accuracy.
Briefly the Test
- Assays 4 cancer markers, MMP1, CEACAM6, HYAL1 and HEC1 by immunohistochemistry (IHC) in formalin fixed paraffin embedded (FFPE) tissue which was already removed at the time of biopsy
- Calculates a ‘Cancer Risk Score’, based on the marker levels, from 0-10 with higher scores corresponding to higher risk of subsequent cancer development
- Classifies a patient based on the risk score as:
‘Low Risk’ (Score <0.5),
‘Intermediate Risk’ (Score > 0.5 and ≤ 5.4) or
‘High Risk’ (Score >5.4) and finally
- Provides the Cancer Rate for a given Risk Score
For example see picture below.
- The BBDRisk Dx® test predicts cancer development equally for:
- all age groups
- the biopsied breast or the opposite breast
- premenopausal and postmenopausal patients
- In patients diagnosed with atypical hyperplasia the cancer rates in different categories will be
- Low Risk – 0% in the first 5 years and 3% beyond 5
- Intermediate Risk – 12% in the first 5 years and up to 20% beyond 5
- High Risk – 73% in the first 5 years and up to 93% beyond 5
- In patients diagnosed with usual ductal hyperplasias, papillomas or any a combination, the cancer rates will be
- Low Risk – 2% in the first 5 years and up to 3% beyond 5
- Intermediate Risk – 15% in the first 5 years and up to 25% beyond 5
- High Risk – 34% in the first 5 years and up to 83% beyond 5
BBDrisk Dx® Test Benefits
The test results will provide personalized information on the biology of your breast mass and the five year risk for developing breast cancer. The BBDRisk Dx® test results along with other information including your health history, can help you and your healthcare provider determine your cancer risk and the most appropriate disease management options.
What is needed to perform the BBDRisk Dx® Test?
There is no additional surgery or any other procedure or material needed from you for the BBDRisk Dx® test. The test is performed on the tissue previously obtained during your breast core or surgical biopsy. The tissue will be obtained from the facility where your biopsy was performed.