Licensing diagnostic tests may benefit everyone
The paper by Gluud rightly compares the introduction of new diagnostic tests to those of a new drug. In contrast to the steps required to be taken by the pharmaceutical industry before a drug can be used on patients, laboratory diagnostic tests only need to prove that they are able to measure the analyte in question. There is no requirement to show that measurement of this analyte is of any use in managing patients. Indeed, an inappropriately used test may have ‘side effects’ which lead to either a delay in diagnosis or further investigation for a condition which the test result has wrongly suggested. Conversely, when a new test is proven to be of value, its introduction in the UK can often be piecemeal, being subject to the vagaries of particular clinician demand and the priorities of local funding.
These two issues may be able to be addressed together. Gluud mentions using the pharmaceutical model to effectively ‘license’ a clinical test for use. In the UK this would require a joint approach from the diagnostics industry and a Department of Health agency to acquire sufficient information on the clinical utility of a new test before it becomes routinely available. There is certainly no shortage of laboratories that would be willing to participate together as a network to carry out these ‘diagnostic trials’. After a test has been licensed for use and is of proven benefit the challenge is then for there to be no ‘postcode lottery’ in its use. Here, its widespread introduction within the NHS could then be facilitated by an organisation equivalent to the role that NICE has in recommending a particular drug’s use.
This way forward could prove beneficial to all parties involved. For the diagnostics industry, currently under financial pressures in only manufacturing ‘generic’ tests, it could allow a widespread deployment of a new diagnostic test. For academic medicine in the UK, the ‘diagnostic trials’ could represent a new direction which is also free from many drug related EU directives. Lastly, for the patient, it means they can be more confident that they will not become the victim of an unproven or misused diagnostic investigation.
Competing interests: None declared
Competing interests: No competing interests