How does Onko-Sure™ Work?
Onko-Sure™ measures a cancer-related increase in the levels of an important set of cellular breakdown products, known as Fibrin and Fibrinogen Degradation Products (FDP or FFDP; FDP will be used to mean either in this guidance document). FDP are over produced in cancer patients because cancer cells release activators for the proteolytic enzymes that cleave fibrin and fibrinogen to form FDP (refer to Figure 1 for an overview of these pathways). In contrast, the pathways that lead to the production of FDP are highly-regulated in healthy individuals, and the normal regulation reduces the production of FDP. In simpler terms, Onko-Sure™ acts as a “barometer for cancer” by simultaneously measuring the multiple FDP species that increase with the activation of cancer-induced degradation pathways. Other tests likely underestimate these levels because they detect a restricted antigen or antigen pool.