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
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