Digistain

Digistain is a Harvard backed medical technology[1][2][3][4] registered and cleared with the UK’s Medicines and Health Regulatory Agency[1] that provides oncologists with decision support data to guide therapy decisions in cancer patients cost effectively with an accelerated turnaround time of under an hour. Comparable diagnostics delay treatment decisions by several weeks and are cost prohibitive[5][1] limiting their clinical value especially in the community setting due to accessibility. Initial validation of Digistain has been achieved with early stage hormone positive breast breast cancer. The technology is used widely by oncologists to support the decision to administer or not to administer chemotherapy in early stage patients.[5]

Digistain uses mid infrared spectroscopy to detect and measure chemical moieties whose concentrations are known to correlate with tumour malignancy.[6][7] By performing such measurements on tumour tissue where genomic expression has already manifested morphologically Digistain’s measurements avoid the inherent challenges that exist in genomic measurement of formalin fixed tissue samples driven by variations in tissue fixation time.[8][2]

The Digistain research was funded by the National Institute of Health Research, Imperial College NHS Trust and also the Royal Society. The technology was spun out of Imperial College in 2021 as a commercial venture and received initial investment from Y Combinator and Harvard among other Silicon Valley tech investors.[9][10]

History

The Digistain technology was created at the Imperial College Physics Department by Hemmel Amrania[5][11] and Chris Phillips.[12][13] The concept underpinning the technology was proposed by Nicholas Wright, Head of Pathology at Cancer Research UK and William Otto in order to eliminate non concordance in histological grading. Examples of histological grading inadequacies include the Nottingham Grading system for breast cancer where the non-concordance of histological grading is chiefly responsible for the overtreatment of breast cancer with cytotoxic therapy.[14]

Amrania and Phillips devised a method to objectively assess tumour grade using spectroscopic measurements that are reagent free and simple to perform and in the case of breast tumours translated this measure into an evaluation of patient risk to deliver clinical utility and treatment decision support for oncologists.

It was later validated in over 800 patients by Ian Ellis - past president of the international society of breast pathology and joint founder of the Elston-Ellis modification of the Bloom-Richardson grading system for breast tumours.[15] Prof Emad Rakha and Prof Andrew Green of Nottingham University Hospital also led the study.

Digistain has been trialled with leading British cancer treatment centres including Imperial College Healthcare, Nottingham University Hospitals NHS Trust, and Barts Cancer Institute at Queen’s Mary University London.[16][17]

Awards
  • In 2017, President’s Award for Outstanding Research at Imperial College.[18]
  • In 2018, Royal Society Innovation Award.[19]
  • In 2022, Digistain received a Business Start-Up Award from the Institute of Physics.[20]
  • In November 2022, Institute of Physics award for the novel application of spectroscopy to eliminate healthcare inequalities globally.[21]
  • In January 2023, the Innovate UK SMART award by the UK Government to help reduce cancer waiting times and  in the same month  was shortlisted as a finalist in the Medilink Heatlhcare Business Awards for successful export of British technology and advances in digital healthcare.[22]

References
  1. "Rapid breast cancer screening technology could stop unnecessary chemotherapy | Imperial News | Imperial College London". Imperial News. Retrieved 2023-01-31.
  2. "2022 Business Start-Up Award winner: Digistain". www.iop.org. Retrieved January 31, 2023.
  3. Tirumalaraju, Divya (2018-03-14). "New Digistain technology can help grade severity of tumours". Medical Device Network. Retrieved 2023-01-31.
  4. "Sofia Angels Ventures buys into UK-based cancer treatment start-up Digistain". seenews.com. Retrieved 2023-01-31.
  5. "How this AI tool for breast cancer can tell you if you need chemotherapy or not". The Indian Express. 2023-01-15. Retrieved 2023-01-31.
  6. Stojkovski, Bojan (2022-08-08). "Sofia Angels Ventures Helps UK Medtech Startup Digistain Raise $1M to Fight Breast Cancer". TheRecursive.com. Retrieved 2023-01-31.
  7. "'Digistain' technology may transform cancer diagnosis". healthimaging.com. Retrieved 2023-01-31.
  8. "Digistain: a digital staining instrument for histopathology". opg.optica.org. Retrieved 2023-01-31.
  9. "Digistain: We Save Patients From Avoidable Chemotherapy". Y Combinator. Retrieved 2023-01-31.
  10. Novac, Dragos. "Digistain was part of Y Combinator". Nordic 9. Retrieved 2023-01-31.
  11. "New "revolutionary" AI breast cancer diagnostic launched". Med-Tech Innovation. 2022-12-13. Retrieved 2023-01-31.
  12. "New technology that could detect cancer faster and more accurately wins a Royal Society Innovation Award | Royal Society". royalsociety.org. Retrieved 2023-01-31.
  13. Writer, GEN Staff (2018-03-13). "Novel Method More Accurately Grades Breast Cancer Biopsies". GEN - Genetic Engineering and Biotechnology News. Retrieved 2023-01-31.
  14. Ivanov, Milen (2022-08-03). "New Investment in Digistain INC". Sofia Angels Ventures. Retrieved 2023-01-31.
  15. Amrania, H.; Woodley-Barker, L.; Goddard, K.; Rosales, B.; Shousha, S.; Thomas, G.; McFarlane, T.; Sroya, M.; Wilhelm-Benartzi, C.; Cocks, K.; Coombes, R. C.; Phillips, C. C. (2018). "Mid-infrared imaging in breast cancer tissue: an objective measure of grading breast cancer biopsies". Convergent Science Physical Oncology. 4 (2): 025001. doi:10.1088/2057-1739/aaabc3. hdl:10044/1/57263. S2CID 80274044. Retrieved January 31, 2023.
  16. "Challenging questions, practical benefits and financial rewards: why medical physics has it all". Physics World. 2023-01-09. Retrieved 2023-01-31.
  17. "New imaging technology could significantly improve the accuracy of cancer diagnosis". News-Medical.net. 2018-03-13. Retrieved 2023-01-31.
  18. "President's 2017 Awards and Medals for Excellence in Research" (PDF). www.imperial.ac.uk. Retrieved January 31, 2023.
  19. "Year in review - for the year ending 31 March 2017" (PDF). www.met.reading.ac.uk. Retrieved January 31, 2023.
  20. "2022 Business Start-Up Award winner: Digistain". Institute of Physics. 2022. Retrieved 27 October 2023.
  21. "Research, enterprise and education excellence recognised by Institute of Physics | Imperial News | Imperial College London". Imperial News. Retrieved 2023-01-31.
  22. "Medilink Midlands Business Awards 2023". Medilink Midlands. Retrieved 2023-01-31.
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