BBDRisk Dx™ Test and Physicians Medical Managements For Treating Pre-Cancerous Breast Growths

This information about BBDRisk Dx™ Test and physicians medical managements will help you manage treatment options for women who have been diagnosed with either atypical or non-atypical hyperplastias.

Hyperplastic Abnormalities and Increased Risk

It is well established that women who are diagnosed with atypical hyperplasias have a five-fold increased risk of developing breast cancer, and those diagnosed with non-atypical hyperplasias have a two-fold increased risk of developing the disease (References 1-17).

Decisional Dilemma in Administering Preventive Therapies

Although chemoprevention therapy with Tamoxifen (Tam), Raloxifene, and/or an aromatase inhibitor (AI), or and surgical therapy with removal of both breasts is/are available for the prevention of breast cancer in women at increased risk, patients as well as their providers, are faced with a decisional dilemma as to whether and how to proceed with preventive therapy. The dilemma is because the diagnoses conferring increased risk based on histology are not precise enough to predict who will go on to develop cancer. The uncertainty surrounding risk places an enormous emotional burden on both patients and their physicians. Current preventive treatments are administered without molecular risk stratification.

As a result, patients who are at low risk are unnecessarily subjected to the potential side effects of the above drugs (such as pulmonary embolism, deep vein thrombosis, stroke, cataracts and vasomotor instability (Tam and Raloxifene), endometrial cancer (Tam), or musculo-skeletal pain and bone loss (AIs)) or to the surgical risk and financial burden of possibly unnecessary mastectomies. On the other hand, patients who are at elevated risk but choose not to undergo cancer preventive therapy because of uncertainty as to their real risk are not receiving the benefit of life saving prophylactic treatments.

Risk Score by BBDRisk Dx™ Test and Medical Management of atypias and other hyperplasias

The tumor biology based BBDRisk Dx™ genomic test will assess multiple markers in the abnormal tissue and generates a ‘Cancer Risk Score’ in the range of 0-10. The test categorizes the patient as ‘Low Risk’, ‘Intermediate Risk’ or ‘Elevated (High) Risk’ (Figure) by comparing the risk score of a patient with the plurality of scores in Silbiotech’s data base. The test Results Report will also provide the ‘Cancer Free Rate or Cancer Rate’ among subjects who have a similar ‘Risk Score’ from the test validation study. (Click the Sample BBDRisk Dx™ Test Report link to open and use the Brower’s File Save As to save it)

BBDRisk Dx™ Guides in Informed Medical Management Decisions

Informed medical management decisions can be guided by the ‘Cancer Risk Score’ and ‘Risk Level’ of a patient. BBDRisk Dx™, provides molecular evidence to stratify and select those individuals at elevated risk, thereby personalizing treatment and minimizing unnecessary side effects. Thus the BBDRisk Dx™ test (Figure) provides a standardized modality to assess the risk of an individual with a hyperplastic biopsy demonstrating that she is at increased risk of developing breast cancer. By providing the personalized molecular risk information, patients can be informed of the benefit of prophylactic treatment and are more likely to comply with the treatment recommendation by their healthcare provider.




For example, standard screening for women with atypical as well as non-atypical tumors whose BBDRisk Dx™ results indicate a “Low Risk” of developing cancer. If BBDRisk Dx™ results indicate that a patient has an Intermediate or Elevated Risk of developing breast cancer, the following medical management options that are currently approved for women with atypias may help reduce risk by 1) detecting it at an earlier more treatable stage, 2) delaying the onset of cancer, or 3) preventing the development of cancer over the long term:

  • Increased surveillance
  • Risk-reducing medications and/or
  • Prophylactic surgery

Disclaimer: Any discussion of medical management options provided here are for general informational purposes only and should not be interpreted as recommendations by Silbiotech, Inc. While BBDRisk Dx™ test results provide useful information, medical management decisions should be made based on consultation between each patient and his or her healthcare professional. The patient and his or her doctor are solely responsible for making any medical management decisions.


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