AMBLor for identifying low-risk non-ulcerated early-stage cutaneous melanomas

Level of innovation

Two experts thought AMBLor is innovative, especially its potential to reduce follow up in people with low-risk melanomas. Three experts considered that AMBLor was a minor variation on an existing procedure. One expert advised that the Royal College of Pathologists dataset uses several histopathological details to gauge the risk of recurrence in melanoma, including tumour mitotic rate, perineural invasion, and perivascular invasion. Other tests are being investigated to stratify risk in early-stage melanoma, including gene expression profiling. These tests are not yet available in the NHS.

Potential patient impact

The classification of low risk in people with non-ulcerated stage 1 to 2B melanomas may provide reassurance that a tumour is less likely to recur or spread. One expert advised that this could be used to inform whether a person should have a sentinel lymph node biopsy. It could also reduce the number of follow-up appointments in this group of people.

The experts advised that a potential harm of AMBLor was possible false-positive or false-negative results. Incorrectly assigning lower risk could prevent people from having more frequent follow ups when needed, while false positives could cause unnecessary worry for patients. But because AMBLor is a rule-out test to identify low-risk melanomas, false positives would be less likely to have adverse effects. One expert commented that the technology is safe but clinical decision making using the results is not yet established. More prospective validation was recommended. Two experts expressed concern that reducing the frequency of follow ups could result in other primary melanomas being missed.

Potential system impact

All experts advised that AMBLor would be used alongside standard care. Reducing the frequency of follow ups and the use of sentinel lymph node biopsies could be cost saving. One expert considered that AMBLor would be much cheaper than other technologies currently under investigation in this area. Most experts agreed that no additional facilities would be needed to use AMBLor. It may result in more time needed for multidisciplinary teams to discuss the results. Additionally, histopathologists may need training to use the kit and to interpret the results. But 2 experts believed this would be minimal because NHS histopathological services are already familiar with the technique.

General comments

NICE's guideline on melanoma is being updated. Two experts advised that this could change the recommended frequency of follow ups, use of sentinel lymph node biopsy and imaging, and adjuvant therapy in stages 1 to 2B melanoma. One expert commented that there would need to be advice on how AMBLor would fit into this evolving patient pathway.

All experts thought that more research is needed, including prospective studies on the effect of AMBLor on clinical decision making and the number of sentinel lymph node biopsies and follow ups for people with low risk. One expert believed that AMBLor has great potential but needs more validation especially in stage 2A and 2B melanomas. Ideally, research would be prospective, but a large retrospective prospective series should also be considered.