MOLDX classic question "When do I submit a new TA for a new platform? How do I know?

ANSWER ONE

Today on July 11, I got a reply from the MOLDX info service and one of the senior MDs, Dr Angie Charnot-Katsikas.   She describes 3 tiers, 

• the first tier is 'do nothing', 
• the second tier is "Update text in te dex registry and email us too" and 
• the third tier is "Submit a new TA" more of an A to Z revalidation.   
• She doesn't have precise rules between these there pathways and suggests "check with MOLDX" for advice.

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When a test has been modified in a minor way (ie change in a reagent; minor extraction protocol change) that information does not have to be provided as an update to MolDx.

 However, when a test has been modified in a significant way (ie methodology or platform has changed, for example from microarray to NGS; intended use or specimen types have changed) an email should be sent to MolDx informing us of the changes and the test information should be updated in DEX.  

A TA is required for significant changes, to ensure that they have been adequately validated and that the test still meets criteria of the policy.

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ANSWER TWO

MolDx had a public webinar in June 2023 about its use of Z codes with United Healthcare, and there was a Q&A.  I asked the question about when a TA update is needed, and Dr. Bien Willner answered my question as below.  

• What amount of change to a lab procedure requires notification and new TA? Then, do you have to wait for it too come back approved, before using the test.
  • Let’s say you have a test with Z code and covered. Dr Bien Willner
  • Now you modify it. Tests are constantly being optimized.
  • In general, as long as the description of the test doesn’t change, the analytes, the intended use doesn’t change, we don’t care
  • If you change the brand of analyzer, we just assume you validated that and don’t tell us
  • You extract DNA more efficienctly, don’t tell us, your description doesn’t change
  • If you FUNDAMENTALLY change, like microarray to NGS, you drop the old version, tell us you are doing that and send us information about the validation you did to assure equivalence. It doesn’t need a new Z code. 
  •  You need to update the DEX registry (for example, your test title/description probably says microarray and must edit to read NGS)
  • If you need more, we will tell you so when we get your information
  • If you go from 12 to 25 genes, tell us what you did and why, just tell us and ask our direction what’s required. Minor = nothing for us (examples just stated.) Major = submit, but never a new Z code (perhaps very rare exceptions).