GOSH - NHS GMS Alliance ctDNA national transformation project Health Economics

Description

The NHS Genomic Medicine Service infrastructure, including the seven Genomic Laboratory Hubs (GLHs), enable the full repertoire of genomics testing for cancer patients in the NHS in England as outlined in the National Genomic Test Directory (Test Directory). Most of the somatic cancer testing in the Test Directory is based on testing the genetic make-up of an individual's tumour. This requires a tumour sample to be taken and then sent to the GLHs for testing. Increasingly it is becoming possible to use blood samples to test the circulating free DNA (cfDNA) for the presence of disease-causing mutations in circulating tumour DNA (ctDNA), also known as liquid biopsy testing. ctDNA based testing has now been validated, pan-cancer, in a number of different trials including I-SPY2, FLAUAS, AURA3, SCRUM-Japan, GOZILA, GRECO, MYSTIC, PEGASUS, COBRA, SOLAR1 and plasmaMATCH. ctDNA testing for EGFR gene mutations is already included on the Test Directory for lung cancer patients. To build the evidence base for the further roll out of ctDNA testing in the NHS, NHS England convened a group of experts to scope a project to explore ctDNA starting with suspected stage 3/4 non-small cell lung cancer patients. ctDNA samples will be taken from at least 700 patients with suspected thoracic malignancy without a confirmed histological diagnosis of stage 3/4 non-small cell lung cancer for direct gene panel analysis for those genes already approved on the Test Directory. ctDNA samples taken prior to the start of this project for patients with non-small cell lung cancer taken at the same time as tissue biopsy or after histological verification in parallel to tissue molecular analyses will also be included in this health economics evaluation. Numbers to be confirmed.

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