Avero Diagnostics launches test for early-stage melanoma progression with AMLo Biosciences
February 2, 2023 – Avero Diagnostics (Bellingham, WA and Irving, TX) today announced the U.S. launch of AMBLor® for identification of early-stage melanomas at low risk of progression. Avero Diagnostics has licensed the underpinning technology from AMLo Biosciences Ltd (Newcastle upon Tyne, UK) and has developed the AMBLor test in their laboratory. This is the first laboratory test of its kind that can identify melanomas at low risk of progression and enable physicians an opportunity to provide a more personalized approach to disease management.
Skin cancer is the most common of all cancers, and the incidence rate of melanoma, one of the most severe forms of skin cancer, has been rising rapidly over the past few decades. The American Cancer Society estimates around 100,000 new melanoma cases are diagnosed annually, with approximately 7,500 people per year likely to die of the disease.1
AMBLor® technology identifies the presence of two prognostic biomarker proteins, AMBRA1 and loricrin, in the skin overlying the tumor. Absence of both these biomarkers in AJCC early-stage (stages I and II) melanoma is associated with tumors at normal or high risk of progression. Normal expression of one or both biomarkers is associated with a low risk of progression.
Currently, the risk of disease progression (metastasis) is based on the American Joint Committee on Cancer (AJCC) staging criteria, in which tumors classified as early-stage are surgically treated followed by a 5-year clinical monitoring period. Approximately 15% of patients with early-stage melanomas will go on to develop metastases, but all patients are recommended to follow the same regimen.2 Improving the risk stratification of early-stage melanomas could spare 85% of patients from unnecessary follow-up and psychological stress.
Dr. Maureen Basius, anatomic & clinical pathology specialist, commented, “Patients often experience a huge amount of anxiety relating to a melanoma diagnosis and AMBLor® is the first test available that offers a way to provide accurate, clinically validated prognostic information relating to tumor progression. With the current guidance recommending the same treatment regimen for all early-stage melanoma patients, AMBLor® will enable physicians to provide a more personalized approach to disease management and will provide patients peace of mind if identified as low-risk of metastasis.”
In September 2022, AMLo Biosciences and Avero Diagnostics entered a license agreement allowing Avero to develop, market, and distribute AMBLor® technology across the U.S. AMBLor® technology fits into the existing histological analysis of melanoma specimens with local pathology teams sending samples to Avero Diagnostics for analysis.
Ryan Fortna, MD, PhD, President of Avero Diagnostics and practicing dermatopathologist, added, “Incorporating AMBLor testing into melanoma analysis can further inform clinical guidance and patient follow-up beyond the typical AJCC staging. We are excited about how this test can improve patient management choices.”
Avero Diagnostics is a physician-owned CLIA-certified, CAP-accredited clinical laboratory, dedicated to providing high quality anatomic pathology, clinical pathology, molecular pathology, and diagnostic services to physicians and their patients. Avero Diagnostics helps healthcare providers and organizations make informed decisions by providing sub-specialized pathology services in the areas of breast, dermatopathology, gynecologic, hematopathology, gastrointestinal, molecular, and urologic pathology. Avero is focused on improving healthcare delivery to patients through the research and development of novel diagnostic equipment and assays, offering a faster and more accurate result.
Avero Diagnostics Contacts
Adrienne Donovan, Avero Diagnostics
About AMLo Biosciences Ltd.
AMLo Biosciences Ltd (AMLo) is an innovative medical device company that specializes 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 personalized cancer management.
AMLo is a spin-out from Newcastle University in the UK. The research and discovery of the novel biomarkers that comprise these new devices emerged from the Newcastle University laboratory of Penny Lovat, Professor of Cellular Dermatology and Oncology. 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.
There are almost 288,000 worldwide cases of melanoma diagnosed each year, 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.
AMLo Biosciences Ltd. Contacts
AMBLor® technology evaluates protein biomarkers found in the epidermis. In normal skin, these proteins are clearly expressed but original research2 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 20213. The final cohort comprising over 550 samples will be submitted for publication in late 2022. Further studies are ongoing, including a prospective observational study to demonstrate clinical utility.
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% cases3. 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 >1100 patients suggest that AMBLor® has superior prognostic value to current AJCC staging criteria and combined sentinel lymph node biopsy (SNLB), which are current standards of care.
Melanoma is diagnosed in nearly 100,000 people each year in the USA and is implicated in nearly 25,000 deaths4. It is the 5th most common cancer in the UK with about 19,000 new cases each year and is the main cause of cancer death in the under 45s5. Incidence is increasing worldwide due to greater sun exposure and an ageing population6. The vast majority of melanomas are classed as low risk, early-stage Stage l (70%) or Stage ll (20%) melanoma7 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 further8, 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.
AMBLor® has been developed in the USA by Avero Diagnostics and is available through a CLIA laboratory service.
AMLo Biosciences Contacts
David Macdonald, AMLo Biosciences USA
- American Cancer Society. Key Statistics for Melanoma Skin Cancer. Available at: https://www.cancer.org/cancer/melanoma-skin-cancer/about/key-statistics.html Accessed November 2022.
- Ellis R et al, British Journal of Dermatology (2020) 182, pp156–165 https://onlinelibrary.wiley.com/doi/full/10.1111/bjd.18086
- Ewen T, et al. Validation of AMBLor as a prognostic biomarker for non-ulcerated cutaneous AJCC stage l/ll Melanoma. Presented at the 18th International Congress of the Society for Melanoma Research Congress. 28–31 October 2021. Pigment Cell Melanoma Res. 2022;35(1):97–184.
- GLOBCAN 2020. US factsheet. Available at: https://gco.iarc.fr/today/data/factsheets/populations/840-united-states-of-america-fact-sheets.pdf. Accessed September 2021.
- GLOBCAN 2020. UK factsheet. Available at: https://gco.iarc.fr/today/data/factsheets/populations/826-united-kingdom-fact-sheets.pdf Accessed February 2022.
- Global Coalition for Melanoma Patient Advocacy. Fighting Melanoma Together’. 2020. Available at: https://www.melanomauk.org.uk/2020-melanoma-skin-cancer-report Accessed March 2022.
- National Cancer Registration and Analysis Service. Routes to diagnosis of cancer by stage 2012-2013 workbook (link is external). London: NCRAS; 2016 accessed via www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/melanoma-skin-cancer/incidence#ref-11
- Gershenwald JE, et al. Melanoma staging: Evidence-based changes in the American Joint Committee on Can