IVDR concering flowcytometric panels

[Eleni Linskens]

Currently a lot of laboratories have a 10 or 12-color flow cytometer. However most/all (upcoming) IVDR panels are 8-color panels. When I look at the content of the panels, mostly the same markers are used, however in other combinations. Some combinations in the in-house panels do have benefit in interpretation of results and in TAT of reporting the results. Furthermore, with the 8-color IVDR panels, we will need more tubes (and more sample) for the same results versus in-house 12-color panels. However, using IVDR 8-color tubes will most times result in the same diagnosis.
Since there are no IVDR 12-color panels, are those reasons good enough to use in-house panels? Or do we have to see the IVDR 8-color panels as equivalent CE-IVDs which meet ‘patients’ needs at an appropriate level of performance?’
If we can use in-house 12-color panels, which specific documentation/requirements are needed? Do we need a notified body for these panels?

Concerning detection of minimal residual disease by flow cytometric analysis, I have a second question. These panels are patient specific and are composed with specific aberrant markers based on the leukemic associated immunophenotype of the patient. Therefore, it will not be possible to use commercial IVDR panels. Do we need specific documentation other than an in-house validation for these panels?

[Pieter Vermeersch]

You can only use an in-house test if you have an unmet patient need. This includes a different technique which is not similar in performance (e.g. flow cytometry or ELISA).Guidance regarding what is acceptable as motivation will be included in the guidance document on lab-developed tests that is expected in fall 2022.

[Pieter Vermeersch]

The European commission published a guidance document on significant/non-significant modifications of IVD tests for IVD manufacturers:
MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR

The European draft version of the guidance document on lab-developed tests that is expected fall 2022 refers to this document for significant/non-significant change. This includes information on the use of a different analyzer.

There is currently no guidance on patient specific panels. I think guidance for professional organis

[Pieter Vermeersch]

There is currently no guidance on patient specific panels. I think guidance for professional organisations could be very useful.
I personally think that we should have the option to validate a test “personalized panel”.

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