RE: NYS CLEP. What exactly is it?23 Oct 2024 22:30
Balance 66,
Perhaps you are unaware that the use of LTD's has, for a long time been largely unregulated in the US. As such tests become more sophisticated and integral to critical medical decisions the FDA has moved to change that but it has been a slow process that has met with some political resistance. FDA has determined that it will soon require all LTD's to undergo proper scrutiny under their oversight. This is common knowledge and I raised a question on this with Burrows during one of his webinars Maybe a year or so ago. You should be able to find that and his reply on the corporate website.
The recent ruling by FDA requiring some LTD's comply with NYS CLEP is an interim and final step on the FDA's route towards full oversight.
The comment by OBD that NYS CLEP is much more rigorous than the oversight of the majority of LDT's whilst true, does not state the simple truth that any oversight is much more rigorous than the previous scenario. It is a classic smoke and mirrors statement suggestive of something significantly beyond the reality.
I do suggest you research this further NYS CLEP approval is not clinical validation it is recognitions that laboratory protocols and procedures meet required standards and yes, that the test basically does what is claimed but only on the evidence of a very small cohort. I will be very surprised if they sell significantly more tests because of this 'landmark decision'.
By the way the FDA document you link to refers people to the CLEP document I have posted for the detail of the NYS CLEP approval process so your assertion that the FDA document is the authority on this is plain wrong.