Senate bill 3404, the 'Valid Act', and 'advanced functional testing'

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circular
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Senate bill 3404, the 'Valid Act', and 'advanced functional testing'

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Not that long ago I listened to Kara Fitzgerald's podcast episode about 'advanced functional testing' that includes 'laboratory developed tests' titled What does “Evidence-based” look like in Functional Lab Testing? I thought it was interesting and helpful, both providing some context within which to understand the emergence of so many novel tests while also describing the potential advantages and pitfalls of them, including illustration by way of example of such a test that turned out not to be valid in the long run. In short:
... there are a lot of wrinkles there where these functional labs can really be helpful but with standardized lab tests you get the advantage of FDA approval in that the FDA is governing over the manufacturing of those things. The labs aren’t actually making the tests. The labs are set up appropriately to take these tests from external sources and then to just run them and to report those values and hopefully to make some sense of them for you. We live in a little bit of a different space, laboratory developed tests so LDT’s are things that aren’t as standardized that you kind of have to do yourself as a laboratory.

There are pros and cons to both worlds and it really depends on what you’re testing ...
More recently I came across mention of S.3404, the 'Valid Act', which seeks to regulate laboratory developed tests. Regulation of these tests could slow development and raise the prices of these tests. On the other hand, we might be able to have more confidence that their often expensive cost is justified.
ApoE 3/4 > Thanks in advance for any responses made to my posts.
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