A New Look at Cancer Diagnostics
One of the challenges with cancer diagnostics is a lack of definitive answers. Current diagnostic tests provide physicians with new ways to improve the diagnosis and management of cancer but can have their challenges as well. For example, some tests may have good sensivity but low specificity. The standard approach to analyze results sets a single cutoff to optimize either sensitivity or specificity. This can result in an overlap in population due to a tradeoff in sensitivity– the ability to correctly identify positives cases of cancer, and specificity- the ability to correctly identify disease-free cases. Inadequate sensitivity can result in undiagnosed cancers and delayed treatment, whereas low specificity can result in unnecessary procedures and patient anxiety.
As shown by Figure 1, a single cutoff can result in an overlap of the popluation resulting in false positives and false negatives.
To help achieve greater accuracy and peace of mind for physicians and patients, we have developed the Clinical Intervention Determining Diagnostic (CIDD)™ Approach. The CIDD approach uses two cutoffs to enhance both sensitivity and specificity so the population can be stratified into three groups based on the likelihood of cancer. One group that has a high likelihood to be disease-free and could be excluded from further evaluation; a second that receives the already scheduled standard of care; and a third that has a high likelihood of cancer and could receive accelarated intervention.
Next, we apply the concept of the Multi-Analyte Diagnostic Readout (MADR)™ Assay. The MADR assay is the first to combine protein and DNA biomarkers into one assay to optimize clinical performance. Using this approach, we can increase the sensivity and negative predictive value at an established MMP protein cutoff. This helps enhance the clinicial performance to reduce the size of the population between cutoffs (i.e. the standard intervention group) and provides physicians with actionable results that other diagnostic tests may not. The CIDD and MADR approaches are the core foundation behind our CertNDx™ molecular diagnostic tests.