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 in early-AJCC (Stage I) 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]

Validated biomarkers

The AMBLor® biomarkers have now been validated in three independent powered cohorts of over 400 patients with AJCC stage I melanoma with known clinical outcomes demonstrating their clinical accuracy and prognostic utility.[1]

The high negative predictive value 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. Those patients can benefit from a step down of their follow-up burden.
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Sensitivity [1]

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Specificity [1]

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Positive Predictive Value [1]

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Negative Predictive Value (absolute risk of metastasis in low risk sub set) [1]

Charts indicate sensitivity and specificity of AMBLor® as a prognostic biomarker. A negative predictive value (NPV) of 98.3% (and 1.7% 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. [1]

Fits seamlessly into current diagnostic protocols

All biopsy specimens are subjected to histological analysis, i.e. the tissue is sliced into very thin sections, the sections are stained and then examined microscopically for the presence of abnormalities. Because each section is very thin, each biopsy sample generates many more sections than are required.
AMLo has developed a proprietary set of antibodies that can be applied to some of the spare biopsy sections and which accurately stratify patients based on risk of disease progression. Therefore, the AMBLor® tests fit easily into the existing histological analysis of specimens and provide 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

Until now, clinicians were unable to stratify the risk of progression for stage I and II melanoma and all patients were treated as having equal risk. This includes a follow-up regime that involves 4–16 or more consultations over a 1–5 year period.

The AMBLor® test offers the potential for personalised, prognostic information for clinicians and patients over and above AJCC staging alone.

Now there is a way 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 confidently continue to follow the current standard of care.

Patient meeting dermatology consultant

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.

Notable Publications

R. Ellis, et al (A. McConnell, M. Labus, P.E. Lovat authors)

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 Jan;182(1):156–165

References

Ellis R, et al. Br J Dermatol. 2020;182(1):156–65.

Date of preparation: September 2021
Job code: 2021/AMBLor/UK/0015

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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