Description
In 2014, the Pathology and Laboratory Quality Center for Evidence-Based Guidelines (the Center) published a clinical practice guideline on analytical validation of clinical IHC assays. Since the original guideline's publication, the landscape of clinical IHC has changed with the introduction of new predictive markers and the advent of companion/complementary diagnostics. In February 2024, an updated guideline was published to address these changes. Many of the original guideline statements remain similar. However, new recommendations address analytic validation of assays with distinct scoring systems, such as programmed death receptor-1 and analytic verification of FDA-approved/cleared assays, and more specific guidance for validating IHC performed on cytology specimens. This activity will address the updates to the guidelines for IHC assays.

This activity was originally presented at CAP24 as Principles of Analytic Validation of Immunohistochemical Assays: Guideline Update.

Objectives
After completing this activity, you should be able to:

1. Recognize the importance of analytic validation of IHC guidelines.
2. Understand the salient updates to the original 2014 “Principles of Analytic Validation of Immunohistochemical Assays” guideline.

CME Information
Accreditation: The College of American Pathologists (CAP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CME Category 1: The College of American Pathologists designates this internet enduring material educational activity for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Payment Information
To pay with a check, print a copy of this page and send it with your check to the address below. You will be notified when your payment has been processed and you have been registered into the activity.

College of American Pathologists
Education Division
325 Waukegan Road
Northfield, IL 60093-2750

Refund Policy
Refunds will be handled on an exception basis. Please submit your request to the CAP in writing via email at education@cap.org or fax at 847-832-8006.

Technical Requirements
Pop-up blockers must be turned off.

CAP Learning has recognized that some Veteran’s Administration, US Government, and military participants may have difficulty accessing the online activity. If you experience difficulty or have any questions, please contact a representative of the Customer Contact Center at 800-323-4040 option 1 or education@cap.org.

Availability
This activity and evaluation are available March 17, 2025, and expire March 16, 2028, at 11:59 PM (CT). Upon completion of the activity your credit will be awarded. Your certificate may be downloaded from your Transcript.

CC: IHCUPDATE03W.2025