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One of the major flowcytometry companies states up untill this day that when in a tube each every marker is strict CE-IVD, (and used as intended by the manufacturer (without titration)), the total panel could be considered CE-IVD, instead of LDT. Is this correct? The other major flowcytometry company states that this is absolutely not the case.
If the first interpretation is correct, the flowcytometry labs will still have a lot of flexibility.
If not, the impact is enormeous, eg..
* there are only 8-color CE-IVD alternatives on the market, while the tendency today is to work with 10 to 12-color analysers. Expensive machines if systematically 2 or 4 channels are not used…
* will addition of 2 to 4 markers to the CE-IVD 8-color panels be allowed? I assume that it then falls under the category of LDT? Major modification?
* in folow-up, we sometimes need to use specific marker combinations based on the initial expression profile of the malignant population. Such a tube is a LDT. Is a validation then needed for every marker combination possible? This is not realistic.
