Provista Blog > What is ProteoMark® Technology & How Does it Relate to Breast Cancer Detection?
Though imaging is the current standard-of-care in terms of breast cancer detection, it has known limitations. This creates challenges in early detection, especially for women with difficult-to-interpret imaging findings.
Other challenges include:
BI-RADS 3 or 4 patients = 5.2 million US women
Dense Breasts Patients = 15.5 million US women
High Risk Patients: 5.5 million US women
These challenges lead to a high rate of false positive and negative results, thus, there is a clinical need to reduce these issues.
Proteomics is the large-scale study of proteins, which are vital parts of living organisms. Tests based on proteomics detect cellular proteins. Proteins are the mediators of cellular growth and are encoded by genes. However, gene mutations do not necessarily lead to the creation of a mutated protein and may or may not impact tumor growth. Healthy cells have processes to correct most DNA abnormalities before mutated proteins can be made. In cases where tumor cells have misrelated proteomics, the protein biomarkers can often be detected in bodily fluids such as blood, more readily than CTCs or ctDNA.
ProteoMark® Technology uses a highly sensitive ELISA platform to analyze two unique types of biomarkers. Tumor-Associated Autoantibodies, known as, TAAbs, are specific to breast cancer, while Serum Protein Biomarkers, known as SPBs, are sensitive in detecting breast cancer. Specificity is the true negative rate of a predictive test, while sensitivity is the true positive rate of a predictive test. The combination of these two biomarkers with patient clinical data generates a unique protein signature that detects breast cancer in the body and thus, rules out breast cancer in patients that do not have the disease. Thus, by incorporating a multi-marker panel consisting of TAAbs and SPBs, ProteoMark Technology is able to more accurately rule-out breast cancer compared to a single biomarker approach.
This technology could be used in conjunction with imaging to help improve breast cancer detection, especially in patients with difficult-to-interpret imaging findings. Definitively ruling out breast cancer in women or identifying those patients who may need additional follow-up after initial imaging is completed is incredibly helpful to healthcare providers and would reduce costs to patients, healthcare providers and the healthcare system as a whole. By doing this, we can also reduce the amount of false positive and negative results, while still reducing the number of unnecessary biopsies and the anxiety felt by patients who obtain unclear imaging results.
At Provista Diagnostics, our mission is to develop world-class diagnostic tests for indications in breast and gynecologic cancers. As a leading diagnostics company, our aim is to create, produce and market innovative solutions for unmet clinical needs. Our products and services help to diagnose diseases and inform better clinical decisions, thus enhancing women’s health and quality of life. We do this in a responsible and ethical manner with a commitment to excellence in every aspect of our business.