Licensing diagnostic tests may benefit everyone

doi:10.1136/bmj.330.7503.1330

BMJ 2005;330:1330 (4 June), doi:10.1136/bmj.330.7503.1330

Letter

Licensing diagnostic tests may benefit everyone

The first 150 words of the full text of this article appear below.

EDITOR—Gluud and Gluud compare the introduction of newdiagnostic tests with that of a new drug.¹ However, laboratorydiagnostic tests need only to prove that they are able to measurea given analyte, not that the measurement is of any use in managingpatients. An inappropriately used test may have "side effects"leading to a delay in diagnosis or further investigation fora condition that the test result has wrongly suggested. Conversely,the introduction of a valuable test in the United Kingdom canoften be piecemeal, subject to the vagaries of particular clinicians'demand and the priorities of local funding.

Gluud and Gluud mention using the pharmaceutical model effectivelyto "license" a clinical test for use. In the UK this would requirea joint approach from the diagnostics industry and a Departmentof Health agency to acquire sufficient information on the clinicalutility of a new test before . . . [Full text of this article]

Eric S Kilpatrick, consultant in chemical pathology

Hull Royal Infirmary, Hull HU3 2JZ Eric.Kilpatrick@hey.nhs.uk