The test which reliably predicts that a melanoma is unlikely to spread or return has been developed by scientists at Newcastle University.

The pioneering test is expected to be available within 2 years, offering reassurance for patients with melanoma, the most deadly form of skin cancer.

Called AMBLor, the prognostic test for the earliest stagesof melanoma is able to better identify a patient’s true risk of disease progression. It provides all those diagnosed with stage 1 melanoma with more accurate information about the risk of the disease spreading. This is up to 70% of new patients.  

The team tested 400 archived biopsies from patients who had a stage 1 melanoma diagnosis and showed that the test could predict long term prognosis of the disease and in the future could help clinicians develop personalised treatment plans for patients.

Melanoma is increasing worldwide and 17,000 patients are diagnosed every year with the condition in the UK alone.

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Biomarkers

The research identifies biomarkers which form the basis of the AMBLor test and is published in the British Journal of Dermatology. It demonstrates that two protein markers, AMBRA1 and loricrin, are normally present in the epidermis, the upper layer of the skin.  The Newcastle scientists identified that the loss of these markers in patients with early-stage melanoma is associated with high-risk tumours while the markers are retained in the epidermis overlying genuinely low-risk tumours. They have used this discovery to develop the AMBLor testing kit.

By applying the AMBLor test to the standard biopsy of the primary tumour on its removal, patients can be identified who have the low-risk, less aggressive cancers.

At present, the primary tumours are removed by surgery and pathologists study the biopsy under the microscope to determine the stage the skin cancer is at and the risk of it spreading (metastasis). If defined as low risk, the patient is followed up in clinic for as long as 5 years – and it is these patients that the test is able to identify. Approximately 10% of patients with stage 1 melanomas will go on to develop metastasis, resulting in poor prognosis and a 5 year survival rate of 15 – 20%.

Chief scientist Professor Penny Lovat, Professor of Cellular Dermatology and Oncology at Newcastle University and Chief Scientific Officer at AMLo Biosciences, the University spin-out company behind the testing kit says: “Building on our previous studies, this new research demonstrates that the loss or reduction of these proteins indicate that the tumour is more likely to spread allowing us to develop our test, called AMBLor. This can be applied to the standard biopsy and identifies those who have these low-risk, less aggressive cancers.

“As a patient, the AMBLor test tells you if you’re in the low risk category – and can offer you reassurance. It could also save the NHS up to £38 million a year by reducing the number of follow-up appointments for those identified as low-risk.”

"personalised, prognostic information"

Dr Rob Ellis is an Honorary Clinical Senior Lecturer at Newcastle University, and also a Consultant Dermatologist and Chief Medical Officer at AMLo Biosciences. He explains: “My colleagues and I are seeing more and more patients referred to our NHS clinics as the number of cases of melanoma increases – and we know that 17,000 patients are diagnosed in the UK every year.

“What we have developed is a test which will offer personalised, prognostic information – so we will be able to more accurately predict if your skin cancer is unlikely to spread. This is a really exciting finding for clinicians and in the future it will help us tailor the treatment and follow up appointments in an appropriate fashion.”

And patients like Rachel Lucas from Guisborough in the Tees Valley have welcomed the test: “I had been diagnosed with stage 1 melanoma and I was told there was still a risk it could develop. I just thought, I could be the unlucky one and I just didn’t know how serious it could become.

“If someone had been able to offer me this test and said that you’re really genuinely low risk, it would have taken a lot of the worry away and made me feel reassured. It also means if I was high risk then we could do something about it.”

The research was funded by Melanoma Focus, The British Skin Foundation, Cancer Research UK, The Newcastle Healthcare Charities, and The North Eastern Skin Research Fund.

Professor Paul Lorigan, chairman of Melanoma Focus, commented: “We congratulate Professor Lovat, Dr Ellis and their team at Newcastle on this important discovery. Knowing which patients with early stage melanoma are not at risk of their cancer returning will be a key element in how clinicians plan their follow-up. It offers the prospect of treating patients more accurately, reducing their stress and saving the NHS a great deal of money. Melanoma Focus is delighted to have helped fund this research.”

The team have created AMLo Biosciences and are seeking approvals for the test to make it available to patients within a couple of years.

REFERENCE: Epidermal AMBRA1 and Loricrin; a paradigm shift in the prognostication and stratification of AJCC stage 1 melanomas. Robert A. Ellis et al. British Journal of Dermatology. doi.org/10.1111/bjd.18086

A patient's perspective: Pam Royle

ITV news Tyne Tees presenter, Pam Royle, shares her experiences of being diagnosed with melanoma and of being one of the first to try the new test:

“I was diagnosed with invasive melanoma in August 2016. I didn’t actually realise how serious a diagnosis that was at first. I knew it meant cancer but little more than that.

“My consultant Dr Rob Ellis explained invasive melanoma by drawing a diagram for me. It showed how the melanoma can grow downwards through the epidermis to the lower layers of the skin, the dermis and potentially into the blood vessels found there. Mine had invaded the dermis and so was critically close to my bloodstream.

“All kinds of things raced through my head. I feared the worst and imagined how much distress may lie ahead for my family. I didn’t know how to tell them. And I knew I didn’t want to.

“Dr Ellis told me I was very fortunate, as it had been caught very early so there was only about a 5% chance that it may have travelled into the bloodstream.

“I urge everyone who notices any changes on their skin to go to their doctor and seek advice. My lesion was very, very small. It didn’t look dangerous to me – but it was new and changing. It was just a small dark dot, with a lighter wavy surround. I had only noticed it for a few weeks but if I had waited any longer, the outcome may have been very different.

“I was asked by Dr Ellis if I would like to be part of the research his team were doing into a new test, which can predict whether your melanoma is likely to spread or return. As part of the research I was shown a wafer thin slice of my melanoma under a microscope which revealed that I was one of the lucky ones. I am a low risk patient.

“It is remarkable that patients may soon be given this information. Knowing that you are low risk and that your melanoma is unlikely to spread or return will remove a lot of the worry for so many people. It will also free up more NHS services to look after those who are classed as high risk and who need more treatment and care.”