NEW YORK — AMLo Biosciences said Tuesday that it has received UK Conformity Assessed (UKCA) marking for its AMBLor test for identifying early-stage melanomas at low risk of progression.
The test is designed to assess the protein biomarkers AMBRA1 and loricrin in the epidermis to stratify non-ulcerated stage I and II melanomas that are unlikely to metastasize. The absence of the biomarkers in early-stage melanoma is associated with tumors at normal or high risk of progression, the UK-based company said, while normal expression of one or both biomarkers is associated with low risk of progression.
With the UKCA mark, AMLo said it can market the test in Great Britian. The US rights to AMBLor are held by Avero Diagnostics, which introduced the test in that market in early 2023.
"We are excited that AMBLor has now received its UKCA mark and is available to the [UK National Health Service] and private hospitals," AMLo CEO Marie Labus said in a statement. The test is expected to "enable clinicians to provide a more personalized approach to disease management, which may include consideration of the need for sentinel lymph node biopsy."