Spin-out's melanoma biomarker receives UK product safety mark
A revolutionary test for low-risk skin cancer has received a UKCA product mark, paving the way for its introduction to the NHS.
9 September 2024
Developed by Newcastle University spin-out AMLo Biosciences Ltd, AMBLor is a groundbreaking histopathological biomarker test for the personal identification of early-stage melanomas at low risk of progression, post staging diagnosis.
This 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. The UKCA label allows AMBLor to be marketed in Great Britain, meaning the test is now available to healthcare professionals.
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. Nationwide use of AMBLor could help reduce waiting lists by identifying people whose melanomas are low risk and needing fewer appointments, thereby enabling more time slots to be available for other patients.
Improving public safety and preparedness
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. Recently published validation data for AMBLor demonstrated a negative predictive value of 96.5%2, demonstrating the high accuracy with which the test can identify low-risk tumours.
Around 20% of early stage I or II melanomas progress to metastatic disease, and the majority of deaths from melanoma occur in this early-stage group. With no accurate predictor of low-risk melanoma recurrence, all patients have had to follow the same disease management guidance3. This can involve sentinel lymph node biopsy, other imaging tests and up to 5-years of follow-up. Sentinel lymph node biopsy has a significant complication rate and recent meta-analysis has shown it to be less accurate in older people. Patients can experience high levels of anxiety that can affect many aspects of daily life.
Dr Marie Labus, CEO, AMLo Biosciences, commented: “We are excited that AMBLor has now received its UKCA mark and is available to the NHS and private hospitals. Adding this simple, effective, low-cost biomarker assay to the existing early-stage melanoma diagnostic tests can provide accurate prognostic information relating to tumour progression. We believe that it can enable clinicians to provide a more personalised approach to disease management, which may include consideration of the need for sentinel lymph node biopsy, also potentially easing patient anxiety at a difficult time.”
Providing better prognostic information
Melanoma experts reported that having better prognostic information for early-stage melanoma could help reduce the burden of procedures and appointments on both patients and the stretched healthcare resources, plus it could assist in offering tailored treatment options and follow-up.
Mr Aidan Rose, FRCS (Plast), Consultant Plastic Surgeon, Newcastle upon Tyne Hospitals NHS Foundation Trust, added: “AMBLor receiving a UKCA mark is really great news. Now that it is available for use, we are very hopeful that it can be used to aid clinical decision making and help reduce the significant strains that many services are currently experiencing.”
AMLo Biosciences offer an AMBLor e-learning package for pathologists in addition to the AMBLor kit.
