Launch of AMBLor Test Enables Risk Stratification in Early-Stage Melanoma

Avero Diagnostics has launched AMBLor, a first-of-its-kind laboratory test for the identification of early-stage melanoma at low risk of progression. The company developed the test after licensing the underpinning technology from AMLo Biosciences in September 2022.¹

“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,” Maureen Basius, DO, anatomic and clinical pathology specialist, said in a press release.

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.²

Current management strategies for patients with melanoma are based on the American Joint Committee on Cancer (AJCC) staging criteria. Patients with early-stage disease typically undergo surgery followed by 5 years of clinical monitoring, and although approximately 15% of these patients will develop metastases, the recommended intervention remains the same.

Refining the risk stratification of early-stage tumors could prevent 85% of patients from undergoing extraneous follow-up and psychologic stress.

The AMBLor test can identify the presence of two prognostic biomarker proteins, AMBRA1 and loricrin, which are found on the surface of the skin above the tumor. Absence of both markers in the AJCC early-stage (stage I and II) melanoma is associated with tumors at normal or high risk of recurrence, whereas normal expression of one or both markers is associated with a low risk of progression.³ 

“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,” Ryan Fortna, MD, PhD, president of Avero Diagnostics and practicing dermatopathologist, said in a press release.

References

1. Avero diagnostics launches melanoma progression test with AMLo. News release. Avero Diagnostics. February 2, 2023. Accessed February 7, 2023. https://usa.amlo-biosciences.com/avero-diagnostics-launches-melanoma-progression-test-with-amlo/
2. Key statistics for melanoma skin cancer. American Cancer Society. Accessed February 7, 2023. https://www.cancer.org/cancer/melanoma-skin-cancer/about/key-statistics.html 
3. Ellis R, Tang D, Nasr B, et al. Epidermal autophagy and beclin 1 regulator 1 and loricrin: a paradigm shift in the prognostication and stratification of the American Joint Committee on Cancer stage I melanomas. Br J Dermatol. 2020;182(1):156-165. doi:10.1111/bjd.18086