AMBLor: An Innovative Prognostic Test for Early Stage Cutaneous Melanoma

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NovoPath & AMLo Biosciences

 

  • Cutaneous melanoma is the most lethal form of skin cancer with an increasing worldwide incidence. Earlier identification of low-risk patients would enable appropriate stratification and potential access to life saving drug therapy.
  • Biomarker discovery and validation studies at Newcastle University led to the identification of two proteins, AMBRA1 and loricrin (AMLo), which indicates low-risk patients.
  • AMLo Biosciences produced an assay kit containing these proteins “AMBLor”.

 

How NovoPath helped:

  • Validation: Of AMBLor diagnostic antibodies and manufactured kit (stability testing ongoing)
  • Immunohistochemistry: SOP produced for automated immune-histochemical staining and analysis of AMBLor in non-ulcerated early-stage melanomas.
  • Patient cohorts: Establishment and transfer of powered geographically distinct cohorts of AJCC stage I/II melanomas from UK, Spain, Australia, and USA
  • Development-Generated data to validate the clinical utility of AMBLor in AJCC Stage I and II non-ulcerated, cutaneous melanoma in geographical cohorts from USA, Australia, and Europe.
  • Pathologist expertise: Review and blind scoring of large internationally sourced melanoma samples using digital imaging to link with colleagues in Cambridge and Buffalo, USA.
  • Business Support- Supported the establishment of a UKAS approved referral test for AMBRA1 and loricrin test in advance of UK-CA marking of AMBLor, facilitating the commercial launch of a product earlier than planned.  The UKAS referral service is now available to patients internationally.

 

Outcome

Our work supported the publication of a positive NICE MedTech Information Briefing for AMBLor as a prognostic test for low-risk, early-stage, non-ulcerated cutaneous melanoma.

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