UKCA mark for Newcastle spin-out melanoma biomarker

Newcastle University spin-out AMLo Biosciences Ltd have announced the successful receipt of the UKCA mark for their histopathological biomarker test AMBLor.

AMBLor is a test for the personal identification of early-stage melanomas at low risk of progression, post staging diagnosis.

The UKCA label allows AMBLor to be marketed in Great Britain, meaning the test is now available to healthcare professionals.

Using the patients’ original skin biopsy, the test identifies the presence of prognostic proteins in the skin overlying the tumour, which are associated with a low risk of progression.

Bosses of the Newcastle-based firm say the 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.

Dr Marie Labus, AMLo Biosciences chief executive said: “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, said: “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.”