This section is intended for healthcare professionals

AMLo Biosciences has identified two proteins (AMBRA1 and loricrin) in the skin overlying the primary tumour that are lost in melanomas that are at-risk of progression

AMBLor® is a new test in development based on two protein markers that are normally present in the upper layer of the skin (epidermis). Loss of both of these markers overlying early-AJCC (Stage I and II) melanomas is associated with tumour subsets that are at-risk of progression, while one or both are retained in the epidermis overlying genuinely low-risk tumours.[1]

Evaluation of AMBLor® biomarkers

The use of AMBLor® biomarkers as a prognostic marker was initially established in two independent powered discovery cohorts of over 350 UK patients with AJCC stage I melanoma with known clinical outcomes.[1] This initial discovery cohort established that the test is an accurate prognostic marker for stage I melanoma, which is able to stratify patient risk over and above AJCC staging alone. The negative predictive value (NPV) of 98.3% demonstrates the potential for AMBLor® as a rule-out test for patients with truly low-risk melanomas.[1]

The AMBLor® test was subsequently evaluated in two further cohorts of over 400 non-ulcerated AJCC stage I and stage II melanoma from Australia and the USA.[2]

The high NPV (97.14%) of AMBLor® means that the test is very effective at identifying melanomas where the biomarkers have been retained and are therefore at low risk of progression.[2]

%

Sensitivity [2]

%

Specificity [2]

%

Positive Predictive Value [2]

%

Negative Predictive Value (absolute risk of metastasis in low risk sub set) [2]

Charts indicate sensitivity and specificity of AMBLor® as a prognostic biomarker. An NPV of 97.14% (and 2.86% risk of metastasis in low risk subset) indicates the robustness of the assay. This enables patient reassurance and potentially earlier discharge from secondary care of patients with low-risk melanomas, significantly reducing healthcare costs and resources. [2]

Fits seamlessly into current diagnostic protocols

AMLo has developed a proprietary set of antibodies that can be applied to spare tissue biopsy sections and which accurately identifies patients at genuinely low risk of disease progression. AMBLor® fits easily into the existing histological analysis of specimens and provides the pathologist with highly relevant clinical information. Users of the AMBLor® tests will require no additional equipment and minimal training.

The potential for a new standard of care

Currently, clinicians are unable to identify genuinely low risk subsets of patients with stage I and II melanoma and all patients are treated as having equal risk. This includes a follow-up regime that involves 4–16 or more consultations over a 1–5 year period.

In future, the AMBLor® test will offer the potential for personalised, prognostic information for clinicians and patients over and above AJCC staging alone. If recommended in local and national guidelines, there could be the possibility to step down the consultation burden for patients with melanomas that are at low risk of progression. While, for melanomas with an ‘at-risk’ AMBLor® result, clinicians will be able to confidently continue to follow the recommended standard of care.

Close up of dermatologist in clinic examining a mole using a dermatoscope

A future of accurate melanoma diagnosis and better patient outcomes

AMLo Biosciences plans to launch its technology globally and make a positive impact on patients’ lives.

References

  1. Ellis R, et al. Br J Dermatol. 2020;182(1):156–65.
  2. Ewen T, et al. Validation of AMBLor as a prognostic biomarker for non-ulcerated cutaneous AJCC stage I/II Melanoma. Presented at the 18th International Congress of the Society for Melanoma Research Congress. 28–31 October 2021.

Job code: 2022/AMBLor/UK/0015(3)a
Date of preparation: April 2022

AMLo Biosciences Limited is a company registered in England and Wales. Company # 11004534

Trading address: Office 9, The Biosphere, Drayman's Way, Newcastle Helix, Newcastle upon Tyne, NE4 5BX

Registered address: c/o RMT Accountants & Business Advisors Ltd, Gosforth Park Avenue, Newcastle upon Tyne, NE12 8EG, United Kingdom

VAT # 285288950

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