Nuclea's serum-based cardiac biomarkers may be highly effective when combined with existing imaging modalities. The Company's congestive heart failure gene and protein signatures may
help predict severity of disease and heart failure progression as set forth by the American College of Cardiology/American Heart Association guidelines, which includes the level of failure and prediction of survival. In Stage A, patients are at high risk for
developing heart failure in the future, but do not present functional or structural heart disorder; in Stage B, a structural heart disorder is present, but there are no symptoms at any stage; in Stage C, previous or current symptoms of heart failure are evident in the context of an underlying structural heart problem, but are managed with medical treatment; in Stage D there is evidence of advanced disease requiring hospital-based support, a heart transplant, or palliative care. Nuclea's companion diagnostics are focused on Stages B and C.
Nuclea's 16 protein serum signature coincides with the Seattle Heart Failure Model which accounts for the prediction of survival in heart failure and predicts cardiac myocyte and neurotransmitter function. This congestive heart failure assay may be an excellent companion diagnostic for the use of AdreView (Iobenguane/123 injection). The Company is currently developing five new gene and protein signatures for this indication