Do you mean the list required by COM.40200, or a validation procedure?

The list is just a list of those test you have modified from manufacturer's 
instructions, or developed in-house from ASR's (any IHC test you do in which 
you modify dilutions, detection, AR etc).

For validation, The FDA LDT rule is not final yet (at least was not at NSH in 
September when we had a workshop on the topic). I suppose CAP could require 
additional validation beyond what CLIA already outlines (and is outlined in the 
COM items after 40200). CAP currently has a recommendations for ER, PR  and 
Her2:  in the range of 25-50 negative, 25-50 positive with a range of positive 
from weak to strong. Statistically concordant compared to known antibody 

If FDA goes through with their proposal you can expect much more extensive 
validation (vendors run hundreds to thousands of cases to meet FDA validation 

-----Original Message-----
From: Donna Emge via Histonet [] 
Sent: Thursday, October 13, 2016 12:18 PM
Subject: [Histonet] Laboratory Developed Test LDT process example for 
antibodies, specifically P16

P16 antibody is soon to move from an FDA approved IVD to a LDT. I have not 
performed a LDT before. I read COM.4020. Would someone be willing to share one 
of their LDT workups for an antibody that meets CAP requirements? I want to 
make sure I am on the right track and do not miss anything.

*Donna J. Emge, HT(ASCP)*

Histology Manager

South Bend Medical Foundation

(574) 234-4176 ext. 1345
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