Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
One out of 5 experts were familiar with or had used this technology before.
All of the experts agreed that the technology is novel compared with standard care and is expected to be used as an alternative to established methods such as flow cytometry. One of the experts explained that clonoSEQ is based on a combination of highly optimised multiplex polymerase chain reaction and next generation sequencing (NGS) with internal controls. The elements themselves are not novel, but the combination of them and optimisation for specific cases is what makes the technology novel. Three of the experts commented on issues with current methods such as poor sensitivity and analytical difficulties, which could be overcome by NGS.
Four of the experts said that the technology is more sensitive than standard care. This offers the possibility to detect lower levels of minimal residual disease (MRD), giving a more accurate prognosis to allow personalised decision making for precise treatment. One of the experts explained that clinical trials are ongoing to establish whether MRD is useful to make treatment decisions for multiple myeloma and chronic lymphoblastic leukaemia. Another expert said that MRD is only relevant for people who are already in complete remission. One expert also said that adults currently have a much higher failure rate of marker identification compared with children. NGS may show enhanced performance of marker identification in this group.
One of the experts explained that the technology can provide more equal access to MRD assessment, which is only available through clinical trials for most people. Two experts stated that the technology and MRD as a whole need further verification before being used to inform clinical decision making. They also said that the technology is likely to cost significantly more than standard care, both because of the cost of the test and training. The other 3 experts acknowledged that the assay may cost more upfront but said that the costs of the assay will offset current system costs and significant cost savings will be seen downstream for all 3 indications.
Three of the experts commented that clinical facilities may need to be upgraded if clonoSEQ was adopted in the NHS. Clinicians will also need additional training to use clonoSEQ, which is provided by Adaptive Biotechnologies. Three experts also outlined the potential harms of false positives and false negatives, which could lead to over- or under-treatment. These risks are present with other diagnostic technologies too. If clonoSEQ is adopted, 4 of the 5 experts expect the technology to be used in fewer than 10 specialist centres across the UK.