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It is predicted that gene diagnostics will become fundamental for future individualised treatment strategies in cancer patients following initial technological investigations and a step-by-step clinical validation. This report is a health technology assessment (HTA) of the use of a novel gene diagnostic assay in acute myeloid leukaemia (AML) with a focus on the technology, the patient, the organisation and economic aspects. In 202 patients with AML, a diagnostic bone marrow or a peripheral blood sample was available for gene analysis, identifying favourable risk translocations by a commercial (HemaVision®) multiplex reverse transcription polymerase chain reaction (RT-PCR) screening assay covering 28 fusion transcripts. The multiplex RT-PCR technology identified five fusion transcripts in five samples not identified by conventional cytogenetics and increased the number of patients identified as having a favourable prognosis from 16 to 21; one translocation identified by cytogenetics was not found by RT-PCR analysis. Using a prospective questionnaire analysis, a convincing 95% (19/20) patient acceptance was documented for the diagnostic genetic analyses and the outcomes. However, patient understanding requires individual time and dialogue, in accordance with patient rights and modern individualised treatment strategies. The implementation of this strategy may benefit from already existing research laboratories forming a homogenous organisation using standardised technologies, which will make Denmark a high-quality partner in international clinical trials of new therapeutic strategies. The average economic cost per patient analysed using this technique is €600, which represents a modest &lt;1% increase in the total average cost of €75,000 for AML treatment. In conclusion, this HTA documented that the technology complements classic fluorescence in situ hybridisation (FISH) and provides additional information that can be used in response evaluation via already existing laboratories, but not without an increase in expense for health authorities. However, the increase in cost is limited compared with the costs of therapy and new drugs.

european oncology and haematology

Health Technology Assessment of Multiplex Reverse Transcriptase Polymerase Chain Reaction Screening for Translocations at Diagnosis in Acute Myeloid Leukaemia