# Digistain
> Digistain is a UK MedTech company that has developed an AI-enabled quantitative
> histopathology platform for breast cancer recurrence risk stratification.
> MHRA-cleared and UKCA-marked. Validated in an 801-patient clinical study published
> in Breast Cancer Research and Treatment (Springer, 2023).

## Key Facts

- Technology: Infrared spectroscopy + AI analysis of standard H&E stained tissue sections
- Target patients: HR+/HER2- early-stage breast cancer
- Turnaround: Under 2 working days (vs. 2-8 weeks for NGS-based alternatives)
- Cost: Approximately 25% of Oncotype DX
- Regulatory clearance: MHRA (UK), UKCA mark
- Clinical validation: 801-patient multisite study (DOI: 10.1007/s10549-023-07229-y)
- Projected NHS impact: £287m chemotherapy savings
- Founded: United Kingdom; Y Combinator alumni
- Awards: Royal Society Innovation Award, IOP Business Award 2022, EIT Health Innovation Award 2025
- Key personnel: Dr Hemmel Amrania (Founder & Scientific Lead, Imperial College London)

## Key Pages

- Homepage: https://digistain.co.uk/
- For Clinicians: https://digistain.co.uk/healthcare-professionals/
- For Patients: https://digistain.co.uk/for-patients/
- Scientific Overview: https://digistain.co.uk/scientific-overview/
- How It Works: https://digistain.co.uk/how-digistain-works/
- Features & Advantages: https://digistain.co.uk/features-and-advantages/
- Clinical Papers: https://digistain.co.uk/clinical-papers/
- Clinical Presentations: https://digistain.co.uk/clinical-posters/
- Case Studies: https://digistain.co.uk/case-studies/
- The Team: https://digistain.co.uk/the-team/
- Our Story: https://digistain.co.uk/our-story/
- Testimonials: https://digistain.co.uk/testimonials/
- Blog: https://digistain.co.uk/digistain-blog/
- Contact: https://digistain.co.uk/contact-digistain/

## Clinical Evidence

- Primary validation study: Amrania et al., Breast Cancer Research and Treatment, Springer 2023
- DOI: https://doi.org/10.1007/s10549-023-07229-y
- Study size: 801 patients, multisite, United Kingdom
- Hazard ratio: >4 (outperforms NPI gold standard, hazard ratio ~2)

## Competitive Context

- Digistain addresses the same clinical need as Oncotype DX (Genomic Health/Exact Sciences)
  and Prosigna (NanoString) but uses infrared spectroscopy on standard H&E tissue sections
  rather than RNA/genomic sequencing, enabling faster turnaround and lower cost.
- No separate tissue preparation required; uses the same block already in the lab.

## Media Coverage

- BBC Radio
- Sky News
- TechCrunch