Learn About The Science Behind the BBDRisk Dx® Test

The science behind the BBDRisk Dx® test is based on more than a decade of Research and Development. Silbiotech, Inc. has developed the BBDRisk Dx® test to address the unmet need for managing patients diagnosed with high risk masses including atypias, usual hyperplasias and papillomas.

Discovery of Risk Signature

Previously Dr. Poola and colleagues undertook ground breaking research to understand the biology of atypical hyperplasias with funding from the National Cancer Institute (NCI), National Institutes of Health (NIH) and Susan G. Komen for the Cure. For the first time they showed that progression to cancer was associated with significantly increased levels of several cancer markers and the activation of a number of pathways that are known to promote cancer development. They also showed that increased levels of certain oncoproteins predicted the actual development of breast cancer. These findings were published in highly prestigious medical journals (Nature Medicine 2005, PMID: 15864312; Clinical Cancer Research 2006, PMID: 16899629; and Clinical Cancer Research 2008, PMID: 18281563; Cancer Prevention Research 2019, PMID: 31239263).

The following publications are the scientific basis for BBDRisk Dx® Test development.

Cancer Prevention Research 2019

Clinical Cancer Research 2008

Clinical Cancer Research 2006

Nature Medicine 2005

BBDRisk Dx® Clinical Test Development

Silbiotech, Inc. expanded upon the published information with SBIR grant funds from the National Science Foundation (NSF, grant number IIP-1314287) and the NCI, NIH (CA173919 and CA206774) to develop the BBDRisk Dx® test including validation of novel biomarkers and design of a proprietary algorithm for risk stratification (Cancer Prevention Research 2019, PMID: 31239263).

The Science Behind the BBDRisk Dx® Test Includes Validation

The BBDRisk Dx® test was developed and validated using a total of 550 samples from several prominent institutions (UCLA Medical School, California, Leeds Hospital, UK, Howard University Medical School, Washington, D.C. and Hartford Hospital, Connecticut). Of the 550 samples, 250 were from patients who subsequently developed cancer after a minimum of 1 year and a maximum of 13 years (cancer developed group). The other 300 samples were from patients who had no prior breast cancer and did not develop cancer for a minimum of 5 years and a maximum of 19 years (cancer-free group). Based on our results on 550 samples used gave a power of more than 99% and a significance level of 0.0001.

We describe in the publication, Cancer Prevention Research (2019, vol.12 pp 471-80; PMID:31239263), that the molecular signature predicts cancer development equally for

  • all age groups
  • the biopsied breast or the opposite breast
  • premenopausal and postmenopausal patients

In the above publication we also present the cancer rates among women with atypical hyperplasia and categorized the patients into low, intermediate and high risk groups for the first 5 years after biopsy and beyond.

  • 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 are

  • 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® – First Genomic Test for atypical or non-atypical hyperplasias

The BBDRisk Dx® test is the first biological risk stratification tool developed specifically for hyperplasia masses. The algorithm developed provides the most comprehensive risk assessment available. The test will provide unique cancer marker based information in terms of a ‘Cancer Risk Score’, whether a patient is ‘Low Risk’, ‘Intermediate Risk’ or ‘High Risk’ for developing breast cancer in the first five years and beyond. Based on the BBDRisk Dx® test results the patients and healthcare providers can now make an informed decision in managing the breast disease.