The Evaluation of diagnostic laboratory tests and complex biomarkers
a summary of a Diagnostic Summit held in January 2008 and released by the Royal College of Pathologists (www.rcpath.org)
BIVDA cautiously welcomes the outcomes from this meeting in the form of 10 recommendations regarding evaluation of diagnostic tests. BIVDA will be responding formally on the summary in due course.
However industry would question the practicality of introducing such a scheme and would see any UK requirement to have evaluation before introduction of tests into the UK as a possible barrier to trade and against the spirit of EU legislation.
BIVDA was also disappointed that, as a responsible industry and key stakeholder in the laboratory medicine community, industry was notable by its exclusion from the summit meeting.
13 March 2008 |