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PGX Clinical Validation

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PGX Clinical Validation Posted: Mon Aug 15, 2016 12:33 pm
Hello, this is my first post. My question is:

1.What is the clinical validation process for qualitative molecular test?

2. What are the COLA guidelines for the clinical validation of qualitative molecular test?
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pgxbirdie
 
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Joined: Mon Aug 15, 2016 11:27 am

Re: PGX Clinical Validation Posted: Wed Aug 17, 2016 11:24 am
The link to COLA included in this reply should answer all of your questions regarding verification of performance specifications. If not please let us know.

www.cola.org/storage/lg13.pdf
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Susan.Cramer
 
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Joined: Wed Nov 19, 2014 8:31 am

Re: PGX Clinical Validation Posted: Mon Aug 22, 2016 6:15 am
Hi pgxbirdie -- COLA requires the same method verification procedures that are required by CLIA: Accuracy, precision, reportable range, and verification of reference range – for FDA approved methods. For non-FDA approved methods – these same parameters must be ESTABLISHED by the lab, plus sensitivity and specificity, including evaluation of interfering substances. At this time, COLA does not have any specific requirements for “clinical” validation or clinical utility. This topic may be addressed in future COLA criteria, but as of yet we do not oversee clinical utility. If you have any more questions, please feel free to reach out to me directly or call us at COLA at (800) 981-9883.

The LabGuide linked to above has been updated and is available to all COLA customers through their COLAcentral portal.
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VFarrell
 
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