Two new reports released by Sense About Science and the Association of Clinical Biology, and the Royal College of Pathologists and the PHG Foundation address the need for government oversight of diagnostic testing kits and the potential for misdiagnoses. The reports on the heels of a Science Council report released at the end of January that stated the need for a regulated structure for the assessment and implementation of the $8 billion diagnostic technology market Since there is currently no UK regulation of testing kits, the PHG Foundation and Royal College of Pathologists are calling for the creation of a publicly accessible database containing evidence of test performance in order for medical testing to be more evidence based. The reports stress that home testing kits are accurate, but it is still up in the air as to whether or not they are useful. In light of the reports, the British In Vitro Diagnostics Association called for tighter regulations on “do-it-yourself” kits, which are without a CE mark and can be bought from countries that are not subject to EU regulations.

Source: Medical Laboratory World

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