Learn More 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 focused on precancerous breast tumor biology. Silbiotech, Inc. has developed the BBDRisk Dx™ test to address the challenges faced by healthcare providers in managing patients diagnosed with high risk tumors including atypias, usual hyperplasias and papillomas.

Discovery of Risk Signature

Previously Dr. Poola and colleagues undertook a ground breaking research to understand the risk signature of precancerous hyperplastic breast tumors 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 from pre-cancer 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 progression. 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).

BBDRisk Dx™ Clinical Test Development

Silbiotech, Inc. expanded upon the published information with SBIR grant funds from the National Science Foundation (NSF) and the NCI, NIH to develop the BBDRisk Dx™ test including validation of novel biomarkers and design of a proprietary algorithm for risk stratification.

The Science Behind the BBDRisk Dx™ Test Includes Validation

Silbiotech, Inc. validated the BBDRisk Dx™ test using tumor samples from several clinical centers. Thus far, studies have included samples from over 500 patients across four clinical centers and with clinical follow up information for up to 19 years —the first and the largest study of its kind to date.

BBDRisk Dx™ – First Genomic Test for pre-cancers

The BBDRisk Dx™ test is the first biological risk stratification tool developed specifically for precancerous breast tumors. 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 ‘Elevated Risk’ for developing breast cancer in the first five years after precancerous diagnosis and beyond. Based on the BBDRisk Dx™ test results the patients and healthcare providers can now make an informed decision in managing the precancerous breast disease.