Companion Diagnostics

Tumor-specific Antigen (TSA) Targeted Therapy Utilizing Both NEO-102 and NEO-201 Clinical Programs

  • 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 which was submitted to the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH)
  • Precision Biologics is working along with the Laboratory of Pathology at the National Cancer Institute in Validating and Qualifying the NEO-201 IHC diagnostic assay
  • These assays may also have additional utilities as a diagnostic test, including early detection of cancer
  • 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