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Digistain LTD

About

Imperial College spin-out and Y-Combinator alumnus Digistain LTD has developed a novel biomarker platform that provides clinicians with an assessment of the likelihood of a patient’s breast cancer recurrence. Designed in collaboration with CRUK by some of the leading names in the field, our solution was created in response to engagement with over 1,500 oncologists worldwide who reported a critical, pressing need for a cheaper and faster method of stratifying patients by risk compared with existing methods.

Utilising infrared spectrometry, the AI-enabled machine learning algorithm analyses patient biopsy samples to generate an accurate risk report predicting the 10-year risk of distant recurrence if treated with 5-year systemic endocrine therapy alone. This report then provides clinicians with the confidence to support their decisions regarding adjuvant chemotherapy, ensuring each patient receives the appropriate treatment tailored to their individual biology.

Unlike traditional methods, the technology is entirely reagent-free and can be deployed in a decentralised manner, utilising existing infrastructure already widely available in routine pathology labs. The result: rapid, scalable risk stratification at a fraction of the cost and turnaround time, helping to reduce delays in treatment initiation and improve access to personalised care.

Our mission is simple: every woman deserves accurate, affordable, and equitable risk stratification, no matter where she lives. We intend to deliver exactly that.

Key Facts

Based on real-world feedback from over 600 UK clinicians:

  • 88.2% reported that post-surgical risk stratification delays treatment decisions by at least one week
  • 64.6% identified risk stratification as the single greatest source of delay in the breast cancer care pathway
  • 70.6% indicated that innovation in this area would meaningfully improve the patient pathway

The conclusion is clear: the greatest system-level inefficiency in breast cancer care occurs at the point of tumour risk assessment, the critical juncture that informs MDT decision-making.

Digistain directly addresses this gap:

  • Reduces turnaround time from 2-6 weeks to same-day results, streamlining the entire care pathway
  • Robustly clinically validated, with 99% accuracy at 5 years and 95% accuracy at 10 years (Coombes, R.C. et al., Breast Cancer Res Treat, 2024)
  • Already in routine clinical use across 5 continents

Successes in UK/NHS

Since its launch, Digistain has received a number of awards recognising its contribution to scientific and healthcare innovation, including the Imperial College President’s Award, Royal Society Innovation Award, Innovate UK SMART Award, and two Institute of Physics Innovation Awards. The company has also secured over £1 million in grant funding from UK bodies, including NIHR and Innovate UK, to support ongoing research and adoption. The technology is MHRA certified and CE marked, and was selected for the NHS Innovation Accelerator to support the adoption of innovative technologies within the NHS. Through this programme, Digistain has been introduced into NHS settings via structured service evaluation and pilot programmes in collaboration with multiple trusts, including Charing Cross Hospital, Wolverhampton Hospital, West Suffolk Hospital, and Nottingham. Furthermore, Digistain has also achieved nationwide coverage with major UK medical insurers, including Bupa, WPA, and Healix.

Company details

Revenue

£0-2m

Funding Status

Series A

Markets already exporting to

Asia Pacific, Africa, South America, Europe, Middle East

Desired Markets

UK and USA

Desired customer types

Healthcare Providers and Prescribing Oncologists

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