Dear colleagues,
I would be interested in hearing feedback from any labs currently offering a molecular diagnostics service. In particular, experience with either the Qiagen Rotor-Gene Q or Life Technologies real-time PCR systems such as the ViiA7. Additionally, are labs that perform molecular diagnostics using manual or automated techniques for DNA/RNA extraction?
The European Commission is currently working on revising the European Directive on in vitro diagnostics, and from my understanding makes the validation of ‘home-brew’ tests a requirement (labs accredited to ISO15189). Many current molecular diagnostics tests are not currently CE-IVD marked. Is it therefore sufficient for non-CE marked tests to be acceptable for diagnostic use if 1) the hardware (e.g. PCR analyser) is CE-IVD marked and 2) the assay is thoroughly validated in-house? How are labs ‘future-proofing’ their molecular assays in view of evolving legislation?
Best wishes,
Phil
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Dr Phillip J Monaghan BSc MSc PhD
Senior Clinical Scientist
Department of Clinical Biochemistry
The Christie Hospital NHS Foundation Trust
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