AMBLor prognostic melanoma biomarker receives UKCA Mark

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New biomarker test aims to improve early-stage melanoma treatment

AMLo Biosciences has announced the successful receipt of the UKCA mark for AMBLor, a groundbreaking histopathological biomarker test for identifying early-stage melanomas at low risk of progression.

This in vitro diagnostic (IVD) test can reliably stratify non-ulcerated AJCC stage I-II melanomas, potentially sparing patients from further diagnostic procedures and lengthy follow-up schedules.

The UKCA label allows AMBLor to be marketed in Great Britain, making it available to healthcare professionals.

A recent Freedom of Information Act (FOI) request from the Liberal Democrats revealed a 25% increase in patients on NHS waiting lists for skin cancer treatment, with around 3,500 patients waiting longer than the 62-day standard to start treatment.

Nationwide use of AMBLor could help reduce waiting lists by identifying low-risk melanomas, thereby freeing up appointments for other patients.

Dr Marie Labus, CEO of 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.”

Mr Aidan Rose, Consultant Plastic Surgeon at 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.”



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