In April 2016, a blood-based early detection system for colon cancer has been approved by the FDA. The inventive biomarkers could be applied in an analogous way for breast cancer detection. Both tests have similar sensitivity and specificity, suggesting a good chance of the present test also to be approved in a similar setting. Notably, a key argument for the approval by the FDA has been the likelihood of increased acceptance by the relevant population thus reinforcing screening participation.
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- Blood-based easy to perform pre-screen to current standard mammography
- Likelihood of much higher compliance of eligible women and consequently increasing screening participation
The initial study included blood samples of 130 age-matched donors that comprised early breast cancer stages (T1N0M0), non-invasive DCIS (ductal carcinoma in situ) and healthy controls. The methylation intensity was measured by means of pyrosequencing. Currently, an additional 400 blood samples are being analyzed. In parallel, the inventors are establishing a NGS based protocol for methylation detection to improve the technical sensitivity.
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