Diagnostics · Breast cancer prognostics
Digistain
A mid-infrared scan of an unstained tumour slice, converted into a recurrence risk score in about an hour. One peer reviewed validation study stands behind it. The gene expression tests it is measured against carry prospective randomised trials.
A beam of invisible light
The slide is not stained. That is the point. A pathologist cuts two adjacent sections from one wax block of tumour, sends one for the usual pink and blue dye, and mounts the other on calcium fluoride, which is transparent to infrared light.
The unstained section goes into a bench spectrometer. Proteins absorb mid-infrared light at one wavelength because of their amide bonds. Nucleic acids absorb at another because of their phosphate backbone. The ratio of the two absorptions gives a number.
That number is the Digistain Index. It stands in for the nuclear to cytoplasmic ratio, which rises as tumour cells divide faster and carry more disordered DNA. Combine it in a statistical model with patient age, tumour grade, tumour size and node status and the output is the Digistain Prognostic Score.
No reagents. No RNA extraction. No courier to a laboratory in California.
The 70 percent problem
Cancer grading is still done by eye. The team opened its 2018 paper with the reason: an analysis of more than 24,000 biopsies graded by 732 breast cancer graders found agreement about 73 percent of the time.
Disagreement at the microscope becomes a treatment decision. For women with hormone receptor positive, HER2 negative early breast cancer, the question after surgery is whether endocrine therapy alone is enough. Get it wrong one way and a cancer returns. Get it wrong the other way and a woman takes a toxic drug she never needed.
Since 2018 the usual answer in England has been a tumour profiling test. NICE recommends five: EndoPredict, ICH4+C, MammaPrint, Oncotype DX and Prosigna. Oncotype DX is processed in the United States. That distance, and the price, are the gap Digistain aims at.
A physicist and his professor
Hemmel Amrania did a PhD at Imperial College London on the biomedical applications of ultrafast laser spectroscopy. He built the instrument with Chris Phillips, a physics professor who later became Dean of the Faculty of Natural Sciences. In 2012 they published the first instrument in Optics Express.
Imperial patented the method. The 2015 application was filed by Imperial Innovations Limited, the college technology transfer arm. Licensing to an industrial partner was explored and did not happen, so the college released the patent to the two inventors.
Phillips left the board of the UK company on January 27, 2023 and ceased to be a person with significant control the same day. He remains on what the company calls its clinical board. Amrania is now the sole active director and the only registered controller of Digistain Limited.
The 801
The evidence cited is one paper, in Breast Cancer Research and Treatment in 2024, with R Charles Coombes of Imperial as first author and Carlo Palmieri of the Clatterbridge Cancer Centre among the co-authors.
It is retrospective. Researchers took tissue microarrays from 801 women treated at Nottingham City Hospital between 1998 and 2006, all hormone receptor positive and HER2 negative, all with three or fewer positive nodes, all on tamoxifen and none on chemotherapy. Median follow up was 12.7 years. Ninety percent never had a recurrence in ten years.
The score sorted them. Area under the curve for recurrence free survival was 0.81 at five years and 0.75 at ten. Negative predictive value, the number that matters if the purpose is to reassure a woman she can skip chemotherapy, ran from 0.96 to 0.99 at five years and 0.84 to 0.95 at ten. Positive predictive value ran from 0.02 to 0.24, expected in a cohort this low risk.
The authors were careful. Training and validation sets came from the same hospital. The comparison with MammaPrint is drawn from a published figure in a different trial, not from running both tests on the same women.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| 2018 pilot | Double blind pilot on adjacent slices from 75 blocks. The index correlated with tumour grade at p = 0.0007. Grading agreement, not outcomes. | Public record |
| 2024 validation | Retrospective, single institution, 801 archived patients on endocrine therapy alone. AUC 0.81 and 0.75 at 5 and 10 years. Hazard ratios for low versus high risk of 1.80, 1.83 and 1.77. Funded by the National Institute for Health Research. Two authors are the chief executive and chief scientific officer. | Public record |
| Against Oncotype DX | Conference abstract only, SABCS 2024. 233 node negative Charing Cross patients already scored by Oncotype DX were rescored. Oncotype classed 50 percent low risk, Digistain 44 percent, and every Oncotype low risk patient was also low risk on Digistain. The title says randomized; the method is random selection of archived cases. | Partner-stated |
| Promised paper | In December 2024 the company said that data formed part of a larger multi-centre study set to be published early the next year. No such paper appears in PubMed as of September 23, 2026. | Not found |
| Registered trials | A ClinicalTrials.gov search on September 23, 2026 returned zero studies, although the company says it holds Health Research Authority approval for ongoing trials. | Not found |
| Comparators | TAILORx randomised 6,711 women with a midrange Oncotype DX score and found endocrine therapy noninferior to chemoendocrine therapy. MINDACT is a phase 3 randomised trial of the 70 gene signature. Digistain is not among the five tests NICE recommends. | Public record |
| Regulatory status | The company calls the test MHRA-cleared and UKCA-marked. MHRA guidance states that registration is not accreditation, certification, approval or endorsement. No FDA 510(k) or PMA record exists. | Claim differs from the record |
| Patents | The founding case was filed by Imperial Innovations in 2015; the US patent granted in 2020 and was reissued in April 2026. A second family, filed in January 2023 by Digistain Inc., is pending; its international application has lapsed. | Public record |
| Commercial footprint | Imperial reported in 2022 that patients in India and the USA were using the system and that talks with NHS trusts were under way. The US laboratory partner is Protean BioDiagnostics. No named NHS contract was found, and the cancer centres said to reimburse the test are unnamed. | Company-stated |
Read plainly: the physics is real and the 2024 paper is a competent retrospective validation in a well documented cohort. What does not exist is what the established tests have, a prospective study in which treatment was assigned by the score and outcomes compared. Oncotype DX has TAILORx. MammaPrint has MINDACT. Digistain has one archival cohort from one hospital, one conference abstract, and a multicentre paper promised for early 2025 that has not appeared.
What to watch
- The multicentre outcome paper announced in December 2024. Until it is published, the peer reviewed record is one study.
- Any trial registration. A test that guides chemotherapy decisions would normally leave a registry trail.
- The precise regulatory basis: which UKCA route and which intended use, as against the shorthand of MHRA-cleared.
- A NICE assessment. Digistain is absent from the guidance that decides which of these tests the NHS pays for.
- Spain. The 2025 EIT Health breast cancer challenge prize names Hospital 12 de Octubre in Madrid as the first site.
In their words
“Even with this modest number of samples, the correlation we saw between the DI score and the H+E grade would only happen by chance 1 time in 1400 trials.”
Chris Phillips, co-inventor, Imperial College London, 2018 · Independent
“What we learnt is that they struggle with identifying hormone-positive, HER2 negative cancer patients who can safely forego chemotherapy.”
Hemmel Amrania, chief executive, to Imperial College London, 2022 · Independent
“This tool will ultimately save lives, save money and prevent patients from the pain and anxiety of needlessly having to wait weeks for results.”
Hemmel Amrania, chief executive, to Imperial College London, 2024 · Company-stated
“It could be a potential game-changer, given the ease with which the test can be undertaken.”
Carlo Palmieri, Clatterbridge Cancer Centre NHS Foundation Trust and co-author, 2024 · Independent
“The study was performed on a cohort who received no chemotherapy and was a low-risk population by design.”
Coombes and colleagues, Breast Cancer Research and Treatment, 2024 · Public record
“Information on the accuracy of commercial genomic tools is not readily available and cross-comparisons may also be confounded by nuances of the patient population and methodology in such studies”
Coombes and colleagues, Breast Cancer Research and Treatment, 2024 · Public record
“It gives the same information about the need for chemotherapy at almost one-fourth the current costs.”
Manish Singhal, senior consultant medical oncology, Apollo Hospitals, quoted by the US laboratory partner · Partner-stated
“Registration of your devices with the MHRA (the UK Competent Authority) does not represent any form of accreditation, certification, approval or endorsement by the MHRA.”
MHRA guidance, GOV.UK · Public record
Related companies
Sources
- Public recordPerformance of a novel spectroscopy-based tool for adjuvant therapy decision-making in hormone receptor-positive breast cancer
- Public recordMid-infrared imaging in breast cancer tissue: an objective measure of grading breast cancer biopsies
- Public recordTumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer, HTG719
- Public recordAdjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer, TAILORx
- Public recordRegister medical devices to place on the market
- Public recordCompanies House filings for DIGISTAIN LIMITED, 12329264
- Public recordUKRI Gateway to Research, projects 10040802 and 10119708
- Public recordPubMed search for the term digistain
- IndependentDigistain technology offers revolution in detailed cancer diagnosis
- IndependentRapid breast cancer screening technology could stop unnecessary chemotherapy
- IndependentDigistain gains clinical data to support rapid breast cancer assessment method
- CompanyDigistain website: home, scientific overview, healthcare professionals, team and news
- CompanyDigistain company profile and founder biographies
- PartnerSABCS 2024 abstract P1-11-27 and the Digistain for MDs page
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
