Gertsen Blinded Validation Project

Summary
OTraces in collaboration with the Gertsen Institute in Moscow performed a blinded validation study on OTraces breast cancer detection products, the CDx Chemistry System for processing automated tests for detection of cancer; BC Sera Dx Immunochemistry test kit for the measurements of proteins that are predictive as a group of the presence on breast cancer in women; and the OTraces Cancer Correlation Computation System for scoring blind samples for breast cancer risk. The study was conducted in two phases; Phase I) used the semi-automated OTraces LHS Chemistry System as the instrument test platform; Phase II used the OTraces CDx Chemistry System, a faster fully automated chemistry processing system. The goal of the market clearance trial was to find a replacement for the current screening mammography method for breast cancer screening (as a primary cost reduction to the Russian health care system). The replacement test must demonstrate performance equivalent to screening mammography. Accuracy of results for the blinded samples were greater than 96% for both sensitivity and specificity and the blinded samples predictive power compared well to the training set internal predictive power of 97%. Of note was that all stage 0 and stage 1 samples, both the training set and blinded samples were called correctly.

Also a different and separate model was constructed to predict cancer stage. This model produced apredictive power of 99% with only one sample scored as stage 1 when actually it was stage 2.