Has Onko-Sure™ been clinically tested?
Published clinical data supports the medical utility of Onko-Sure™, the AMDL-ELISA DR-70® (FDP) immunoassay, for the detection and monitoring of cancers in the liver, gastrointestinal tract, ovarian, lung, breast, colon/rectum, and tongue/oral cavity. A complete list of published references is included below. Onko-Sure™ was used to measure FDP levels in 6,667 patients collectively in the global clinical studies cited at the end of this document. Within these studies, the Onko-Sure™ results consistently correlated with either the positive detection or positive progression of a variety of cancers (refer to Table 1 for a full description of the effectiveness of Onko-Sure™ at detecting a variety of cancers). In total, the published studies describe the detection of 14 different cancer types; however, the numbers of patients representing some of the patient types were not statistically significant. The other cancers that were positively detected by Onko-Sure™ in these trials, albeit with le