US-based pharmaceutical company Radient Pharmaceuticals Corp announced the Journal of Immunoassay and Immunochemistry (April 2010, Volume 31) has published a peer-reviewed journal article written by Dr Andrea Small-Howard and Mr. Holden Harris titled "Advantages of the AMDL-ELISA DR-70 (FDP) Assay Over Carcinoembryonic Antigen (CEA) for Monitoring Colorectal Cancer Patients."

The Journal of Immunoassay and Immunochemistry article introduces Onko-Sure, the AMDL-ELISA DR-70 (FDP) test developed by Radient Pharmaceuticals, as the first new in vitro diagnostic (IVD) cancer test to be cleared by the US FDA since January 14, 1982 for monitoring CRC. The article also discusses the importance of colorectal cancer screening and monitoring tools in enhancing survival in post-operative colorectal cancer patients because approximately 50% of all CRC patients treated will experience cancer recurrence. RPC’s clinical trial is the first head-to-head comparison assessing the effectiveness of Onko-Sure versus CEA for monitoring CRC recurrence.

The article specifically outlines the advantages of the AMDL-ELISA DR-70 (FDP) test over CEA for monitoring CRC; the tremendous economic and healthcare benefits of routine cancer screening, including the potential to detect CRC in its earliest stages where the disease is the most preventable and/or treatable; and the merits of the AMDL-ELISA DR-70 (FDP) cancer test as a welcome, new option for CRC patients. Data covered includes:

  • An overview of the advantages of Radient Pharmaceuticals’ AMDL-ELISA DR-70 (FDP) IVD cancer test;
  • An overview of the deficiencies of the Carcinoembryonic Antigen blood test;
  • Clinical effectiveness comparison of the AMDL-ELISA DR-70 (FDP) test versus CEA in serial samples from 113 biopsy-positive CRC patients during routine CRC monitoring;
  • A schematic describing how the AMDL-ELISA DR-70 (FDP) IVD cancer test measures FDP generated from all major cancers; and,
  • Details on the advantages of Radient Pharmaceuticals’ AMDL-ELISA DR-70 (FDP) test to CEA including data revealing that approximately 50% of CRC patients are CEA negative.

Source: Radient Pharmaceuticals