What are the advantages of Onko-Sure™ over CEA for CRC monitoring?
Onko-Sure™ is the first new in vitro diagnostic cancer test to be cleared by the US FDA for monitoring colorectal cancer (CRC) since January 14, 1982 when Carcinoembryonic Antigen (CEA) was approved. CEA has been in routine usage for many years as a blood test for monitoring CEA, but it also has well known limitations that are related to the nature of the tumor marker9. CEA has been characterized as an oncofetal marker, which implies that it is only present during cancer progression or normal embryogenesis. Evidence exists that contradicts its classification as a pure oncofetal marker; as there are reports of this antigen’s presence in healthy organs and its elevation due to benign conditions that affect the liver10-13, lungs14, and the gastrointestinal system15. Also, CEA is not a good target for a blood test because CEA is normally firmly attached to cancer cells due to its role as an adhesion molecule14. In contrast, the DR-70 (FDP) antigen is freely diffusible in the blood. Onko-Su
