Early-Stage Melanoma Testing Technology Launched in the United States

Clinicians have a new melanoma testing option to provide a more personalized approach to management and treatment.¹ AMBLor was introduced by Avero Diagnostics as the first laboratory test of its kind to identify melanomas at low risk of progression. Developers say the test can identify the presence of 2 prognostic biomarker proteins, AMBRA1 and loricrin. During research in Australia, the United Kingdom, and the United States, AMBLor had a high negative predictive value of more than 97%, which means that the technology is very effective.

“The launch of the AMBLor test to identify early stage melanomas at low risk of progression is an exciting development in skin cancer care. With the high number of early stage patients being diagnosed, further refinement in determining which patients are at high risk for poor outcome will help us better tailor care,” said Sherrif Ibrahim, MD at the University of Rochester Medical Center in Rochester, NY.

The absence of both biomarkers in melanoma stages Iand IIis associated with tumors at normal or high risk of progression, while the presence of either or both biomarkers is associated with a low risk of progression. Many clinicians currently rely on the metastasis staging criteria from The American Joint Committee on Cancer (AJCC), which encourages a 5-year clinical monitoring period after an early-stage tumor is identified and surgically removed. Approximately 15% of patients with early-stage tumors will develop metastases and the same treatment regimen is recommended.

“As we learn more about the molecular underpinnings of melanoma development and progression, we can tap into this information to garner more predictive information for individualized patient management. While we have made incredible strides in the development of clinicopathologic staging, it provides only population-based data. While no test is perfect, we now have access to increasing amounts of gene expression data for melanoma patients and as a specialty, need to conduct larger prospective studies to further validate their place in melanoma patient management. The ultimate goal of gene expression data is when we can integrate their results as standard of care,” Ibrahim added.

Skin cancer is the most common cancer, and the incidence of the most severe skin cancer, melanoma, has been increasing over recent decades. Approximately 100,000 new melanoma cases are diagnosed every year, of which approximately 7500 will be fatal, according to the American Cancer Society.

Avero Diagnostics, based in Bellingham, Washington and Irving, Texas, introduced AMLorto the United States after entering a license agreement in September 2022 with AMLo Biosciences Ltd, based in the United Kingdom.

Reference

1. Avero Diagnostics launches melanoma progression test in US. AMLo Biosciences Ltd. Published February 2, 2023. Accessed February 9, 2023. https://usa.amlo-biosciences.com/avero-diagnostics-launches-melanoma-progression-test-with-amlo/.