Use of RUO reagents in an LDT

Mandy

Involved In Discussions
#1
Our R&D are developing an LDT (laboratory developed test) using RUO (for research use only) reagents.

We are getting close to the handover to scale up and develop the LDT test in a pilot lab (still prior to validation and verification).

The question is - do we have to now change all these reagents - many of them critical parts of the process - to approved/certified reagents. This is a big headache for everyone and there will probably be a lot of opposition.

Thanks
 
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dsanabria

Quite Involved in Discussions
#2
Our R&D are developing an LDT (laboratory developed test) using RUO (for research use only) reagents.

We are getting close to the handover to scale up and develop the LDT test in a pilot lab (still prior to validation and verification).

The question is - do we have to now change all these reagents - many of them critical parts of the process - to approved/certified reagents. This is a big headache for everyone and there will probably be a lot of opposition.

Thanks
I am not sure which standard you are using but why do you think that you need to change?
 
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