Groundbreaking Histopathological Biomarker Test Receives UKCA Mark

September 4, 2024

AMBLor® prognostic melanoma biomarker receives UKCA mark

AMLo Biosciences Ltd announces the successful receipt of the UKCA mark for AMBLor®, manufactured by Medtechtomarket Ltd.

AMBLor – a groundbreaking histopathological biomarker test for the personal identification of early-stage melanomas at low risk of progression, post staging diagnosis – has been awarded the UKCA mark.

AMBLor is the first in vitro diagnostic (IVD) of its kind that can reliably stratify non-ulcerated AJCC stage I-II melanomas that are unlikely to metastasise, potentially segmenting a group of patients that could be spared further diagnostic procedures and lengthy follow-up schedules. 

Using the patients’ original skin biopsy, AMBLor identifies the presence of two prognostic proteins, AMBRA1 and loricrin, in the skin overlying the tumour. Absence of both these biomarkers in melanoma is associated with tumours at risk of metastasis or spread. The presence of one or both biomarkers is associated with a low risk of progression. 

Nationwide use of AMBLor could help prioritise patients in need of faster treatments and reduce waiting lists by identifying people whose melanomas are low risk and need fewer appointments. A recent Freedom of Information Act (FOI) request from the Liberal Democrats shows a 25% increase in patients on NHS waiting lists for skin cancer treatment and around 3,500 patients wait longer than the 62-day standard to start treatment, with some left waiting almost a year[1]. 

The UKCA label allows AMBLor to be marketed in Great Britain, meaning the test is now available to healthcare professionals. Read the full press release from AMLo Biosciences Ltd HERE

References

  1. Skin cancer patients waiting close to a year to start treatment as Lib Dems call for scrapping of VAT on high-factor sunscreen — Liberal Democrats (libdems.org.uk). 19 August 2024.