We still need tests for many illnesses that affect millions, including Long Covid, Myalgic Encephalomyelitis and other idiopathic Infection Associated Chronic Conditions and illnesses. Great to have more test validation requirements, but hope this does not drive up costs too much, slow down innovation, and put end to some promising diagnostics startups, that are already in a competitive field.
Do you agree: If a startup wants to go LDT with its product and missed the May 2024 deadline, the next major milestone is to start before Stage 4: Beginning on November 6, 2027, because you could then still launch while waiting for the approval from FDA!?
On another note, which commercial labs do you expect to be best suited to adapt to the changes?
Liz, do I understand correctly that the requirement to get the CLIA certification is still in place despite the new rule. This rule doesn't eliminate the need to get the certification?
We still need tests for many illnesses that affect millions, including Long Covid, Myalgic Encephalomyelitis and other idiopathic Infection Associated Chronic Conditions and illnesses. Great to have more test validation requirements, but hope this does not drive up costs too much, slow down innovation, and put end to some promising diagnostics startups, that are already in a competitive field.
Do you agree: If a startup wants to go LDT with its product and missed the May 2024 deadline, the next major milestone is to start before Stage 4: Beginning on November 6, 2027, because you could then still launch while waiting for the approval from FDA!?
On another note, which commercial labs do you expect to be best suited to adapt to the changes?
Do you know when to expect the new guidelines for the LDTs from the FDA to be able to actually follow them?
Or are they available already?
They are indeed available - you can find links to everything here: https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests
So many thanks for your response! Amazing Substack!
Liz, do I understand correctly that the requirement to get the CLIA certification is still in place despite the new rule. This rule doesn't eliminate the need to get the certification?
I don't believe this rule changes anything about CLIA. Mara, please chime in if I'm incorrect.