AMBLor® prognostic melanoma biomarker successfully receives UKCA mark

Tuesday 3 September 2024 – AMLo Biosciences Ltd (Newcastle upon Tyne, UK) announce the successful receipt of the UKCA mark for AMBLor. 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 year¹. 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.

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^4,5. 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.”

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-up⁶.

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. Please contact the company for access – details below.

To order the AMBLor kit in the UK or request training details please contact: orderAMBLor@amlo-biosciences.com or telephone 0191 580 7180. For general information: www.amlo-biosciences.com

ENDS.

Contact

AMLo Biosciences

Jane Meaney, CMO at AMLo Biosciences: j.meaney@amlo-biosciences.com  

Marie Labus, CEO at AMLo Biosciences: m.labus@amlo-biosciences.com

About AMLo Biosciences Ltd.

AMLo Biosciences Ltd (AMLo) is an innovative medical device company that specialises in the early detection of skin cancers with metastatic potential. Its goal is to improve the management of skin cancers through risk stratification, enabling targeted and personalised cancer management.

AMLo is a spin-out from Newcastle University in the UK. The discovery and validation of the novel biomarkers that comprise these new devices emerged from the Newcastle University laboratory of Penny Lovat, Professor of Cellular Dermatology and Oncology supported by a National Institute for Health Research (NIHR) Invention for Innovation (i4i) grant (project reference 20993) in association with AMLo Biosciences Ltd. AMLo has collaborated with medical teams in the USA, Europe, and Australia to provide evidence for significantly improved disease-free survival compared to current treatment pathways.

In 2022, an estimated 330 000 new cases of melanoma were diagnosed worldwide⁷, representing a significant market opportunity for accurate prognostic markers.

AMLo is also developing a prognostic test for cutaneous squamous cell carcinomas (cSCC); the second most common form of skin cancer. In addition, it is working on a product for oropharyngeal squamous cell carcinoma (OPSCC) which will enable precision management to reduce unnecessary treatment-associated toxicities.

www.amlo-biosciences.com

About AMBLor

AMBLor technology evaluates protein biomarkers found in the epidermis. In normal skin, these proteins are clearly expressed but original research⁸ led Professor Penny Lovat (CSO) found that they are absent or reduced in early-stage cutaneous melanomas that become metastatic and form secondary, often fatal, cancers.

Confirmatory studies in >400 Stage l and ll melanoma samples from the UK, USA, Australia, and Europe, followed up for over seven years, was published at the Society for Melanoma Research in 2021⁹.

The recent prospectively designed study to demonstrate clinical utility was conducted in 840 samples of non-ulcerated AJCC stage I and II melanomas across two geographically distinct cohorts with 12 years clinical follow-up. The discovery cohort (n=540) showed a recurrence-free survival (RFS) rate of 95.5% (p<0.001) and a negative predictive value (NPV) of 96.5%¹. The validation cohort (n=300) demonstrated a RFS rate of 97.6% (p<0.001) and a NPV of 97.6%².

The data show that a low risk AMBLor score will be assigned to 17% of non-ulcerated Stage l and Stage ll patients and will predict that a melanoma will not spread in 97.1% cases⁹. In addition, the high sensitivity of the test shows that AMBLor has the potential in identifying truly high-risk patients, confirmation of which is the subject of ongoing research. The combined data sets involving >1,100 patients suggest that AMBLor has superior prognostic value to current AJCC staging criteria as the current standard of care.

Melanoma is diagnosed in over 101,000 people each year in the USA¹⁰. It is the 5th most common cancer in the UK with over 19,500 new cases each year and is one of the main causes of cancer death in the under 45s¹¹. Incidence is increasing worldwide due to greater sun exposure and an ageing population¹². The vast majority of melanomas are classed as low risk, early-stage Stage l (70%) or Stage ll (20%) melanoma¹³ and at-risk type surveillance is currently the only form of management for these patients. As more than 97% of Stage l and 82% Stage ll melanomas do not progress further¹⁴, placing everyone on an at-risk investigation and surveillance pathway places a significant burden on healthcare budgets. Surveillance regimens can last up to 5 years, placing extraordinary stress on patients and costs to NHS and private insurers. Potentially releasing around 1 in 5 people from this burden would have a significant impact on resource savings.

In September 2022, AMLo Biosciences Ltd and Avero Diagnostics LLC entered a license agreement allowing Avero Diagnostics to develop, market, and distribute AMBLor technology across the US. AMBLor has been developed in the USA by Avero Diagnostics and is available through a CLIA laboratory service. AMBLor technology fits into the existing histological analysis of melanoma specimens with local pathology teams sending samples to Avero Diagnostics for analysis.

About the UKCA mark

The UK Conformity Assessed (UKCA) mark is a mandatory mark on a product to indicate that it conforms to applicable requirements in Great Britain.

References

1. Skin cancer patients waiting close to a year to start treatment as Lib Dems call for scrapping of VAT on high-factor sunscreen - Liberal Democrats (libdems.org.uk). 19 August 2024.
2. Ewen T, et al. Validation of Epidermal AMBRA1 and Loricrin (AMBLor) as a prognostic biomarker for non-ulcerated AJCC stage I/II cutaneous melanoma. Br J Dermatol 2023. https://doi.org/10.1093/bjd/ljad459
3. National Institute for Health and Care Excellence (NICE) guideline. Melanoma: assessment and management. Last updated 27 July 2022. https://www.nice.org.uk/guidance/ng14
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