Radient Pharmaceuticals Corporation (RPC) has confirmed its post-launch trial ‘Evaluation of AMDL-ELISA DR-70,’ an Onko-Sure in vitro diagnostic cancer test, is on course.
The project is designed to further validate the efficiency of Onko-Sure relative to the Carcinoembryonic Antigen (CEA) marker in colorectal cancer patients.
RPC’s study compares the effectiveness of Onko-Sure IVD cancer test to the CEA marker in a large population of patients (N=976), including non-cancer patients (normal) and patients in stages I through IV (Dukes A through D) with colorectal cancer.
As part of a collaboration agreement with Mayo Validation Support Services (MVSS), MVSS provided RPC with 976 biospecimens and annotation that were tested by Mayo with the standard CEA cancer screening test.
The final study results will be part of RPC’s clinical post-launch validation of Onko-Sure.
Under the agreement, the final RPC study data and corresponding results will be returned to MVSS.