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

The technology described in this briefing is AMBLor. It is used for identifying low-risk non-ulcerated early-stage cutaneous melanomas in children and adults.

The innovative aspects are the immunohistochemical method and detection antibodies in AMBLor. The company claims there is no other technology that can classify risk in non-ulcerated stage 1 to 2B melanomas.

The intended place in therapy would be in addition to standard care in people with non-ulcerated stage 1, 2A or 2B melanomas. AMBLor can be run onsite in secondary or tertiary care.

The main points from the evidence summarised in this briefing are from 3 retrospective validation studies including 1,025 people. They show that AMBLor can identify low risk of disease progression in non-ulcerated stage 1 and 2 melanomas. It is not suitable for identifying high-risk melanomas.

Key uncertainties around the evidence or technology are that there is no evidence on the prospective use of AMBLor in clinical practice, its comparison with standard care, or its effect on treatment decisions, clinical outcomes or resource use.

Experts advised that AMBLor may reduce the frequency of follow ups and the use of sentinel lymph node biopsy in low-risk melanoma. But evidence is needed on its effect on clinical decision making and resource use.

The cost of AMBLor is £175 per test (excluding VAT). The company estimates additional processing costs of £20 per test for tests done in NHS settings. AMBLor would be an addition to standard care but costs may be offset if people with low-risk melanoma have fewer follow-up visits or sentinel lymph node biopsies.