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In vitro diagnostics (IVD) underpin clinical decision making in the NHS, directly impacting the overall quality of clinical decisions and effectiveness of healthcare systems. This is especially true in oncology, where tests are used routinely for screening, diagnosis, prognosis, treatment selection and/or monitoring of malignancies.

Very few new tests are introduced into routine clinical practice. For those that are, the process often takes more than 10 years from market approval,1 suggesting that the route from discovery through to adoption may not be fully functional. NICE evaluates the clinical and cost-effectiveness of new healthcare technologies. A look at its recent guidance shows that IVD in oncology often fall into one of two groups: those that are companion diagnostics with pharmaceuticals and those that are not (Table 13.1). Generally, there is wider adoption of companion diagnostics in the NHS. The reasons for this are numerous, but two of note are:

  • Companion diagnostics frequently have evidence of clinical utility, because they are used in the clinical trials of the drug. This is in stark contrast to other diagnostic tests, which often only have evidence of diagnostic accuracy at most.

  • The companion diagnostic is critical for the effective use of the drug; therefore, the funding mandate for NICE-approved drugs in the NHS may also drive the adoption of the companion diagnostic.

Table 13.1Examples of NICE guidance including IVDs in oncology.

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