[Histonet] Her2:

[Morken, Timothy]

Craig, 

CLIA licensure gives your lab the authority to validate and use ASR's for diagnostics. For something like her2 you will need to compare it to an existing FDA approved antibody, run the statistically significant number of cases (range of positive, and negatives) and show high correlation between them. If you want to use an FDA approved antibody on a different platform you still need to do the validation and compare the results between the platforms. Vendors typically run many hundreds of cases for their FDA approval but most labs run 50 to 100. But with smaller numbers of cases it can be hard to get the high correlation you need (95%+). Your pathologists need to develop a validation plan and decide if it is suitable.


Look at this site and go the link at the bottom for Subpart K, Part 1:  http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html


Look for section 493.1253(B)(2). Below is the intro. The standard is many pages long and tells you what you need to do to use FDA kit on a different platform than the manufacturer used for FDA certification. It is a full validation. 

This same standard applies to ASR's

§493.1253 Standard: Establishment and verification of performance specifications.
(b)(2) Establishment of performance specifications. Each laboratory that modifies an FDA-cleared
or approved test system, or introduces a test system not subject to FDA clearance
or approval (including methods developed in-house and standardized methods such as
text book procedures, or uses a test system in which performance specifications are not
provided by the manufacturer must, before reporting patient test results, establish for
each test system the performance specifications for the following performance
characteristics, as applicable:




Tim Morken
Supervisor, Histology, Electron Microscopy and Neuromuscular Special Studies
UC San Francisco Medical Center
San Francisco, CA

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-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Jb
Sent: Tuesday, January 27, 2015 10:50 AM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] Her2:

Can anyone give me suggestions of what they are using for Her2?  What are your thoughts on FDA cleared kits vs ASR?  Good products/cost efficient....general thoughts. 

Also, does anyone know or have any literature stating that an FDA cleared kit has to be used on a specific platform that it is specified for? 

I have heard that an FDA cleared test has to be used on the company's specific platform to maintain the FDA status.  Does anyone have info/literature supporting this?

Thank you,

Craig

Sent from my iPhone
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