BC-SeraPro™ is a proteomic test for the diagnosis of breast cancer. This test is designed to measure the quantitative expression level of 22 protein biomarkers in the serum that differentiate between breast cancer patients and control subjects. The level of the biomarkers from the patient’s serum sample is compared to the Power3 Medical Products’ patient database.  Statistical analysis by linear discriminant function will analyze the biomarker levels of the patient sample and assign a probability score for the diagnosis of the patient sample. Probability score is ranged from 0.0 to 1.0.  Results of the BC-SeraPro™ test should not be considered a stand alone diagnosis nor a guarantee. 

This test was developed and its performance characteristics determined by the Power3 Medical Products Laboratories.  It has not been cleared or approved by the U.S. Food and Drug Administration.  The FDA has determined that such clearance or approval is not necessary.  This test is used for clinical purposes.  It should not be regarded as investigational or for research.  This laboratory is certified under the Clinical Laboratory Improvement Amendment of 1988 (“CLIA”) as qualified to perform high complexity clinical testing.

BC-SeraPro Blood Draw Kit

Because early breast cancer is asymptomatic, the only way to detect it is through screening. Mammography is currently the widely accepted method for breast cancer screening. However, most women who have an abnormal mammogram do not have cancer.

Mammography often leads to identification of a “probably benign” lesion or an uninformative mammography. Clinicians may be reluctant to refer such a patient for a biopsy; they may also reluctant to do nothing. Often such patients are referred for frequent repeat mammography examinations.

The availability of an accurate and non-invasive test would avoid such repeated mammogram exams, with their attendant discomfort, inconvenience, x-ray exposure, and emotional stress. In such cases, BC-SeraPro™ with 80% sensitivity and 87% specificity, could exclude malignancy at higher accuracy than mammography. As well, BC-SeraPro™ is highly accurate not to miss cancer in those women who have it.

BC-SeraPro™ is then an ideal diagnostic test to evaluate breast cancer abnormalities found by mammogram or breast examination. The test would distinguish women who should have a biopsy from those who can safely avoid one. BC-SeraPro™ could detect the disease at a point when treatment is more effective, less expensive, or both.

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The Rationale for a Blood Test to Detect Early Breast Cancer