AMBLor® NICE Advice[1]
In May 2022, AMLo Biosciences successfully obtained NICE Advice on “AMBLor for identifying low-risk non-ulcerated early-stage cutaneous melanomas”.
NICE noted:
“The evidence suggests that AMBLor risk classification of Stage 1 or 2 melanomas may be associated with disease progression up to 12 years’ follow up. AMBLor is reported to have good sensitivity and negative predictive value. The studies support the use of AMBLor as a prognostic marker for identifying low risk of progression in stage 1, 2A or 2B melanoma. But it is not suitable for identifying high-risk melanoma because of its high rate of false positives. This is in line with AMBLor’s intended use as a rule-out test.”
“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”
“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 comments by independent experts and patient support groups were extremely encouraging. In particular the contribution by The British Skin Foundation:
“AMBLor is a new technology that has the potential to benefit patients and healthcare providers. It could assist with determining appropriate treatment paths for people with melanoma. AMBLor offers a notable change in prognostic tests for melanoma. It may lessen the worries of patients and could save the health service time and resources that can be used elsewhere.”
AMBLor® is in the final stages of product evaluation, and is anticipated to be available for purchase by the NHS hospitals/trusts and private centres in the second half of 2023. The test is currently available through a UKAS-accredited Referral Service at Newcastle-upon-Tyne Hospitals Trust, in partnership with CellPath.
References
- AMBLor for identifying low-risk non-ulcerated early-stage cutaneous melanomas. NICE advice. Available at: https://www.nice.org.uk/advice/mib294/chapter/summary.
Accessed: February 2023.
Job code: 2023/AMBLor/UK/0015(4)b
Date of preparation: February 2023
AMLo Biosciences Limited is a company registered in England and Wales. Company # 11004534
Trading address (Visitors and Deliveries): Office 9, The Biosphere, Drayman's Way, Newcastle Helix, Newcastle upon Tyne, NE4 5BX ///wider.admire.guard
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