Breast CancerScoutTM, a breast cancer detection blood test, uses unique protocols to identify molecular signals from a 2.5 mL blood sample obtained through venipuncture. Our analysis methodology is built upon a novel approach that uses biomarkers shown through clinical research to correlate to patient status. Breast CancerScoutTM can indicate whether or not breast cancer is likely or unlikely to be present in an undiagnosed individual.
Blood Screening Test Data
Mammography, along with ultrasound, and magnetic resonance imaging (MRI) are currently the screening methods used to identify potential breast cancers. Mammography is the most widely applied of these techniques, and along with a clinical breast exam (CBE), is the standard of practice. However, mammography does not offer an ideal screening approach, due to the moderate sensitivity and specificity of the test, limitations related to tissue density or patient age, the exposure of the breast to radiation, and the need for additional scans in a significant number of cases. Breast CancerScoutTM offers both technical and economic performance that exceeds the combination of mammography with a clinical breast exam, but without exposure to radiation. For validation and clinical data study, please contact us.
All protocols of Breast CancerScoutTM are performed as per Syantra’s instructions, which incorporate ISO 13485:2016 approved methods and components. Once the blood test is ordered, a 3 mL blood sample is collected in a supplied Syantra specimen tube. These tubes stabilize nucleic acids for up to one week at room temperature, and for much longer when frozen at –20 °C. After collection, the tubes are sent to Syantra’s laboratory where nucleic acids are extracted, and gene expression determined on a qPCR platform using test components. Proprietary data analysis and quality assurance methodologies are then applied to the data, and a report is generated. This report consists of test results, an indicator of confidence in those results, and a summary of all performed quality control checks. This report is sent back to the ordering clinic or physician for patient follow-up.