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.
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.