Digistain® announces the launch of the Africa technology-transfer partnership; Cape Town, South Africa

Digistain®, the MHRA-cleared, UKCA-marked breast-cancer recurrence risk-profiling technology, today announced a technology-transfer partnership for Africa with Imperial Market Access Healthcare SA (Pty) Ltd., Key Oncologics (Pty) Ltd. and OriGenes Institute. The South African launch will be co-hosted by OriGenes Institute with the gracious support of UVU Africa at Brickfield Canvas, Woodstock, Cape Town, on 2 October 2025. In South Africa, Digistain® is classified as a Class C medical device and will be used in accordance with SAHPRA requirements.

Digistain® uses mid-infrared spectrometry on an unstained tumour section with AI-enabled analytics to produce a single Digistain® Prognostic Score that provides prognostic information to support clinicians in treatment decision-making for eligible early breast cancer patients. The workflow integrates with routine pathology and delivers risk-actionable information within the same day, supporting timely decision-making. Recent peer-reviewed validation in Breast Cancer Research & Treatment demonstrated strong prognostic performance(1), and UK access has expanded through private-payer adoption.

Technology transfer for continental impact

Through this collaboration, Digistain®’s know-how will be embedded into African health systems by combining on-site training, validated sample workflows and robust quality assurance with the continent wide logistics, regulatory and market-access capabilities of the collaborators. “Our mission is to make high-quality recurrence-risk profiling fast, affordable and equitable,” said Digistain® spokesperson, Dr Hemmel Amrania. OriGenes Institute, as lead host within the UVU Africa campus, will build day-to-day laboratory skills, data pipelines and bioinformatics to run the service locally: “We’re focused on turning world-class science into routine clinical practice in Africa,” said OriGenes spokesperson, Dr Hawwa Gabier. To support compliant scale-up across multiple markets, Imperial Market Access Healthcare SA will provide cGXP (includes GMP, GDP, GWP, GVP) distribution, in-market regulatory support and pharmacovigilance, “supporting regulatory compliance and access pathways”, noted Imperial Market Access Healthcare SA spokesperson, Chris Oosthuizen. To accelerate clinical adoption, Key Oncologics will lead regulatory enablement, clinician education and facilitate distribution: “To ensure providers have access to the technology without delay,” added Key Oncologics spokesperson, Jean Lambrechts, COO & RP. The technology transfer will be staged at UVU Africa’s campus; the nexus for community building, training and adoption, ensuring the work is supported within a thriving innovation ecosystem. Together, the collaboration is structured for rapid, sustainable impact across South Africa and the wider continent.

Event details

What: Digistain® South Africa Launch & Technology Transfer Briefing

Host: OriGenes Institute with the gracious support of UVU Africa When: 2 October 2025

Where: Origenes Institute, Brickfield Canvas Building, 35 Brickfield Road, Woodstock, Cape Town

About Digistain®

Digistain® is a UK health-technology company developing AI-enabled optical diagnostics that deliver rapid, cost-effective breast-cancer recurrence risk profiling from unstained tissue sections. The technology is MHRA-cleared and UKCA-marked; with peer-reviewed validation in a cohort of 801 patients and growing UK private-payer availability.

About Imperial Market Access Healthcare SA (Pty) Ltd.

Imperial Market Access Healthcare SA delivers end-to-end healthcare market-access solutions across Africa including logistics, distributorships, multi-market aggregation, regulatory and pharmacovigilance services backed by a broad warehousing and distribution footprint in sub-Saharan Africa.

About OriGenes Institute

OriGenes provides clinical genetic diagnostics, genetic counselling and bioinformatics, translating advanced diagnostics into routine care. OriGenes is based at 35 Brickfield Rd, Cape Town.

About Key Oncologics (Pty) Ltd

Founded in 1998, Key Oncologics bridges global innovation and local need, representing international companies and providing regulatory affairs, market access, medical information, quality assurance, distribution, pharmacovigilance and named-patient programmes.

About UVU Africa

UVU Africa is a non-profit organisation building future-fit, inclusive societies through technology and innovation, with catalytic programmes including UVU Bio. Headquarters: 2nd Floor, Brickfield Canvas Building, 35 Brickfield Road, Woodstock.

This press release is intended for media and stakeholder communication only. Digistain is a Class C medical device and will be used in South Africa in compliance with SAHPRA regulations. It is not intended as medical advice.

Reference:1. Coombes C, et al. Performance of a novel spectroscopy-based tool for adjuvant therapy decision-making in hormone receptor-positive breast cancer:A validation study. Breast Cancer Res Treat 2024 Jan 20 (e-Pub ahead of print).