London, UK – 24 January 2024. A clinical validation study for Digistain’s novel, rapid and cost-effective alternative to transcriptomic risk profiling in order to efficaciously predict disease free survival has been published in the Springer Nature Journal of Breast Cancer Research & Treatment.
The landmark independent clinical study, authored by some of the leading names in breast cancer oncology and pathology demonstrated that Digistain’s breast cancer diagnostic technology is able to accurately predict patients at low risk of disease recurrence who may forgo adjuvant chemotherapy.
Clinical Study Parameters
- 801 patients with Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 – Negative (HER2) Primary Breast Cancer
- Patients with ≤3 positive lymph node breast cancer
- No adjuvant chemotherapy: Systemic endocrine therapy where appropriate
- Median follow up 12.7 years
Clinical Study Results
- Demonstrated high accuracy and predictive performance
- Successfully classified patients as low or high risk with similar accuracy and predictive performance as that reported by other risk stratification tools
- Offers a faster lower cost alternative than existing prognostic testing methods.
- Data highlights the importance of testing patients with Digistain prior to adjuvant chemotherapy decision
- Identified 49% patients with low-risk disease who may safely forgo adjuvant chemotherapy.
About Digistain’s Technology
The breakthrough diagnostic tool was invented by award winning British biotech company Digistain in collaboration with London’s Imperial College and Cancer Research UK. The technology uses a proprietary spectral signature demonstrated to be 97% reproducible. This approach enables precise quantification of long-established pathology markers correlated to chromosomal instability (CIN) and tumour proliferation (including nuclear pleomorphism and mitotic activity) to produce a personalised risk score.
The optical scan technology captures a unique spectral signature from each tumour sample creating over 10,000 data points unique to the individual biology of a patient. Artificial intelligence is then used to analyse the imaging data and calculate a Digistain Prognostic Score that precisely and objectively identifies the risk of cancer recurrence in the next 10 years. This enables physicians to reduce informed actionable treatment decision times from months and weeks to days and hours.
Professor Carlo Palmieri, Consultant in Medical Oncology at The Clatterbridge Cancer Centre NHS Foundation Trust and co-author of the new research paper commented: “This paper shows that using inexpensive technology that doesn’t rely on complex genomic analysis of the tumour is a novel way to assess hormone positive breast cancer to define the risk of recurrence. The clinical evidence presented demonstrates this ingenious new approach can deliver accurate results to differentiate high risk from low risk breast cancer tumours. It could be a potential game changer given the ease at which the test can be undertaken.
The real potential advantage for healthcare is the transformative speed at which this test can be performed, enabling a very fast assessment of the risk of breast cancer recurrence risk. Digistain offers hospitals the ability to analyse their own breast cancer biopsy samples for risk recurrence assessment without need for special chemical processes. This is an exciting and significant technology with real social impact.”
Digistain CEO and clinical scientist Dr. Hemmel Amrania said: “Digistain is at the forefront of rapid and cost-effective personalised cancer treatment decision-making. This new technology speeds up a system that is currently too slow and where time and swift action are precious commodities. This tool will ultimately save lives, save money and prevent patients from the pain and anxiety of needlessly having to wait weeks for results. Importantly, the technology can also reduce the overuse of toxic chemotherapy in many patients.”
FURTHER INFORMATION:
contact@digistain.co.uk
NOTES FOR EDITORS:
About Digistain (www.digistain.co.uk):
Digistain is a breast cancer diagnostics company that has developed an MHRA cleared technology to transform the prediction of breast cancer recurrence risk from a slow expensive manual wet-lab process to a rapid affordable AI enabled solution. The company was created by a team of world class cancer specialists to solve the time, cost, availability and accuracy issues associated with traditional oncology diagnostics. The technology delivers gold standard predictive equivalence to traditional risk scoring analytics and provides clear insights on likelihood of breast cancer recurrence within the next 10 years at dramatically faster speeds and lower costs than the current industry standard.
Digistain has been successfully validated in prominent cancer centres of excellence and demonstrated gold standard equivalency to NICE-approved traditional tumour profiling tests in survival prediction while maintaining best in class sensitivity and specificity.
About Dr. Hemmel Amrania, CEO:
Dr. Hemmel Amrania is a clinical scientist specialising in pathology, with particular interest in tumour grading, clinical trials and medical technology innovation. He graduated with honours from London’s Imperial College in the field of Physics with Mathematics. He pursued his Masters in Optics and Photonics at the SupOptique, Université Paris XI in France.
Hemmel returned to Imperial College to complete his PhD on the biomedical applications of ultrafast laser spectroscopy. During his PhD he patented a novel device to grade tumour biopsies that eliminated non-concordance due to subjective bias. For this work there, he was awarded the President’s Award for Outstanding Research at Imperial College.
Later, along with Professor Chris Phillips, he was recipient of the Royal Society Innovation Prize and also the
Cancer Research Pioneer Award. He worked at London’s Charing Cross Hospital on clinical trials under Senior Medical Oncologist Prof. Charles Coombes and subsequently Prof. Sir Nicholas Wright, the renowned pathologist and Head of Pathology at Cancer Research UK. While at the hospital, he qualified in clinical trials design and medical statistics. After learning of the economic and patient care challenges faced by breast oncologists in determining patient risk – UK patients wait weeks for test results at a cost of several thousand pounds per test report per patient – he sought to apply his research to solve this problem. He developed Digistain – a radically faster and cost-effective way to select patients who could safely forego chemotherapy to improve patient outcome while saving the health payer significant costs.
About Professor Carlo Palmieri:
Prof Palmieri is a Professor of Translational Oncology at the University of Liverpool and Consultant medical oncologist at The Clatterbridge Cancer Centre NHS Foundation Trust. Carlo’s academic and clinical interest is in breast cancer, and his research interests are focused on hormone therapy for breast cancer and brain metastasis. He is actively involved in developing and initiating translational and clinical research trials and leads a number of studies. He is also currently co-leading CCP-UK CANCER, a national NIHR URI funded project which is characterising COVID-19 in cancer patients. He co-chairs the breast group for the Cheshire and Merseyside Cancer Alliance, as well as the National Cancer Research Institute (NCRI) breast group strategic area 2 (Metastatic breast cancer), a member of the NHS England Genomics Clinical Reference Group and has served as expert cancer member of Dept of Health’s independent advisory group on use of antibodies/antiviral drugs in patients vulnerable to COVID-19. He is an advisor to the secondary breast cancer charity ‘Make 2nds Count.
