[Histonet] LDT question

[Erin McCarthy]

Hi All,

I have a validation question - we are looking into buying an RUO rated IHC
stainer for a future multiplexing project. Roche's Discovery Ultra to be
specific.

I have a pathologist that is convinced that we can run our clinical
antibodies on it as an LDT and still bill for the work. The material I have
read up to this point regarding that instrument explicitly states that no
slides can be run for diagnostic purposes. The instrument has software that
allows you to use it to mimic the IVD instruments' software capabilities so
you can validate a protocol on it, then move it right over to the Benchmark
so I can see why the idea that it can run our IVD items seems plausable.
However what I need to know is which is correct?

I do not want to do something that I am uncomfortable doing without
checking with others in my field first.

Thanks!

-- 

Erin McCarthy, HT (ASCP)
Histotechnician

Tempus Labs
600 W. Chicago Ave.
Chicago IL 60654
Ph:(312) 638-6344 Ext.3835

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