FDA-Approved Tests

Eight diagnostic tests or devices supported by the EDRN have been approved by the U.S. Food and Drug Administration for clinical use and 18 EDRN developed biomarker tests are available in Clinical Laboratory Improvement Amendments (CLIA) approved laboratories. Details on the EDRN-supported biomarkers that received FDA approval are listed below.

Purpose of the APOA2-ITQ Test

Biomarker Assay Purpose Year of Approval EDRN Associate Member/Industrial Partner

APOA2-itQ® (analysis of two APOA2 isoforms, APOA2-AT and APOA2-TQ)

Diagnostic aid for pancreatic cancer

June 8, 2023; IVD in Japan

Kazufumi Honda, D.D.S., Ph.D., and Giman Jung, Ph.D /Toray Industries, Inc.

  1. Approval in Japan information
  2. Insurance coverage information: February 1, 2024
  3. EDRN Reference Set Data, in part, were used in Regulatory Approval Submission