Diagnostic biomarkers for melanomas developed by a bioscience spin-out can effectively support the management of patients with stage 1 and 2 melanomas, reducing the need for additional testing or biopsies.

In newly published findings from AMLo Biosciences, researchers have confirmed that the combined biomarkers AMBRA1 and loricrin (AMBLor® histochemical test) can reliably stratify melanomas at low risk of progressing.

This will help clinicians assess a patient’s need for further diagnostic testing, follow-ups and reduce the need for potentially unnecessary therapy.

In doing so, AmLo Biosciences proposes that its biomarkers can offer patients a ‘personalised approach to disease management’ for the fifth most common cancer in Scotland.

Understanding risk

While only around 20% of patients with early-stage melanomas will see their cancer spread, there is currently no way to accurately predict low-risk recurrence which means all early-stage melanomas are treated the same way.

Last year, a systematic review of early-stage melanoma reflected the need for better prognostic testing and risk-prediction models that incorporate biomarkers for improved accuracy. These can help inform follow-up guidelines for patients.

Mr Aidan Rose, NIHR Clinical Lecturer, Newcastle University, added:

“With the increasing number of melanoma diagnoses, there is a clear need for a simple, reliable, low-cost prognostic biomarker with the potential to streamline the care of patients with melanoma and reduce strain on UK skin cancer services.”

According to AmLo Biosciences, under current guidance patients may be recommended to undergo an invasive procedure called sentinel lymph node biopsy to inform their treatment pathway.

With the potential for complications including the accumulation of fluid under the skin near the incision site, wound infection and even lymphedema or haematomas, reducing the need for such procedures with these biomarkers could offer improved patient outcomes.

Now, this validation study funded by the NIHR, British Skin Foundation and Invention for Innovation, looks at 840 tissue samples from stage 1 and 2 non-ulcerated melanomas.

Non-ulcerated means the skin is not broken down over the melanoma and is generally associated with a better outlook for patients.

Of the 840 samples, 698 were identified using the biomarker to be ‘at-risk’ melanomas, while the remaining 142 were identified as low-risk melanomas which will not progress to advanced cancer following removal.

Professor Penny Lovat, Newcastle University Centre for Cancer, Chief Scientific Officer, AMLo Biosciences, and lead author said:

“These robust data from such a large international cohort reinforce the reliability of AMBLor biomarker technology.

“AMBLor offers accurate, clinically validated, prognostic information relating to tumour progression and will enable physicians to offer reassurance to low-risk patients along with a more personalised approach to disease management.”

AMLo Biosciences believe that this diagnostic test addresses many of the key stated ambitions within the Cancer Strategy for Scotland 2023-2033.

In 2022, Public Health Scotland revealed that the pandemic saw “under-diagnosis” of many cancers, leading to later stage diagnosis and higher rates of cancer diagnosis via emergency care.

In the cancer strategy, the Scottish government says it aims to enhance early diagnosis rates by investing in innovation, including biomarkers – and to provide every person diagnosed with cancer ‘effective and individualised care’.

The company says by supporting more personalised care, the biomarkers also closely aligning with the realistic medicine aims of Scotland’s Chief Medical Officer, including improving cancer screening and the cancer journey from diagnosis onwards.

Meeting patient needs

Dr Zainab Laftah, Consultant Dermatologist and British Skin Foundation spokesperson, said:

“Thrilled to see the data behind this innovative British Skin Foundation funded project showing the combined biomarkers, AMBRA1 and loricrin (AMBLor® histochemical test) as a reliable predictor of low risk of melanoma progression.

“This will help offer patients a more personalised approach to disease management, reduce unnecessary invasive procedures and ease pressure on health systems.”

In a clinical advisory board meeting, AMLo Biosciences heard of the heightened anxiety and stress associated with the increased burden of travel for patients in remote and rural areas of Scotland.

AmLo Biosciences told healthandcare.scot that work is ongoing to help the NHS address these challenges and it believes these biomarkers can help ‘reduce unnecessary interventions’ which may save resources and offer reassurance to both clinicians and patients across Scotland.

A representative for AMLo Biosciences says there are already signs of interest for adopting the biomarker test across NHS Grampian, Highland, and Tayside.

Read more: ‘Weaknesses' found in Scotland's cervical screening; Pandemic impact on cancer incidence in Scotland; Cervical cancer unit to treat patients in 30 minutes; Major investment in Scotland's cancer research; Microwaves offer less invasive cervical cancer therapy; All cancer patients to access extra support by 2024

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