Diagnostics

COMPANION DIAGNOSTIC PROGRAM
Tumor-specific Antigen (TSA) Targeted Therapy for Pancreatic Cancer with Utility in Colon Cancer

cancer-diagnostic-precision-biologics

  • Tumor-specific antigen detected by companion diagnostic
  • Companion diagnostic currently used to pre-select therapy- responsive patients
  • Precision Biologics has developed an assay using our current antibodies to stain cancer tissue (immunohistochemistry or IHC) from patients to determine if the target for our therapeutic antibody is present.
  • This assay allows us to predict which patients have the best chance to respond to our antibody therapy
  • Precision Biologics has completed its NEO-102 IHC Validation Report and is currently planning a pre-submission to the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH)
  • This assay may also have additional utilities as a diagnostic test, including early detection of cancer, as well as determining if margins of resection are disease free following colon cancer resection
  • Other assays using patients’ blood are being developed with Precision Biologics antibodies including  a serum ELISA test that may have additional utility to monitor patients undergoing therapy for cancer

“Our monoclonal antibodies have the ability to act as a companion diagnostic platform to our therapeutic program by recognizing the tumor specific antigen that our therapeutic antibody targets and determine which patients are a candidate to receive treatment.”

Philip M Arlen, MD

Chief Executive Officer