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Conclusion

We understand why the FDA wants to leverage pharma to support the shift away from LDTs
with the regulated complementary labelling. Occasionally in diagnostics the stakeholders
can align around new tests and drive rapid change, as seen with BCR-ABL or HLA-B testing
in HIV. But the arrival of a regulated complementary label does not appear to have any real
stakeholder alignment and we at Diaceutics fear it may complicate rather than simplify
clinical decision-making. For this reason we think it does not really further the cause of
personalized medicine.

References

1. http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm, accessed
28/04/2016

2. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm,
accessed 28/04/2016
3. PharmKGB accessed 28/04/2016
4. In Vitro Companion Diagnostic Devices Guidance for Industry and Food and Drug Administration Staff,
2014
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm2623
27.pdf

Originally published at diaceutics.com, 6 June 2016

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