Recommendations from the report of a Diagnostic
Summit on "The evaluation of diagnostic tests and complex
biomarkers", hosted by the Royal College of Pathologists
and the PHG Foundation, held in Cambridge on 14-15 January 2008.
The full text is available at: http://www.rcpath.org/resources/pdf/DiagnosticSummitFinalreport08.pdf
1. A new body should be established to ensure
the evaluation of laboratory diagnostic tests and the creation
of a database of new and existing laboratory tests.
2. This body might be established de novo
along the lines of the UK Genetic Testing Network, or the responsibility
could be placed with existing professional societies such as the
Royal College of Pathologists, the Association of Clinical Biochemistry
or the Academy of Royal Colleges.
3. A publically available database of existing
and new diagnostic laboratory tests should be set up containing
evidence, or explicitly the lack of it, for the validity and utility
of clinical laboratory tests.
4. Where a test evaluation has already been
carried out and published by an appropriate agency it should be
linked to the database.
5. Where evidence is missing for existing
tests, particularly evidence of clinical validity and utility,
consideration should be given to funding the necessary studies.
6. Policy makers and all stakeholders should
be encouraged to address issues around funding and gathering the
necessary evidence for the clinical evaluation of new and complex
biomarkers, and should consider the establishment of private-public
partnerships to increase industry involvement.
7. An independent expert body should be
responsible for the evaluation of the evidence for test performance
and making recommendations about clinical use.
8. Commissioners and health care professionals
should be encouraged to use only those tests where sufficient
evidence of clinical performance exists.
9. Statutory regulators should be empowered
to require that evidence (or lack of evidence) relating to test
performance be placed in the public domain.
10. A more responsive and proportionate
risk assessment during pre-market approval is needed to ensure
Please note that very similar recommendations
were developed almost simultaneously but quite independently by
a working group of the Science Council.
A summary of the Science Council report, including
its recommendations, is available at http://www.sciencecouncil.org/documents/diagnostics_execsummary.pdf
20 April 2008