Genomic Medicine - Science and Technology Committee Contents


APPENDIX A

  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

RECOMMENDATIONS

  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 patient safety.

  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



 
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