Avero Diagnostics announced the US launch of AMBLor, a laboratory test for the identification of early-stage melanomas at low risk of progression.

AMBLor technology identifies the presence of two prognostic biomarker proteins, AMBRA1 and loricrin, in the skin overlying the tumor, according to Avero. 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 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.[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,” Maureen Basius, DO, anatomic & clinical pathology specialist, said in a company news release. “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 United States.

References

1. Ellis R et al, British Journal of Dermatology (2020) 182, pp156–165 https://onlinelibrary.wiley.com/doi/full/10.1111/bjd.18086