Avero Diagnostics launches test for early-stage melanoma progression with AMLo Biosciences
Avero Diagnostics (Bellingham (Washington) and Irving (Texas), USA) 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, and have 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, the most severe of skin cancers, 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 tumour 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 licence 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.”
References
- 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