Scientific Overview
Digistain® works biologically downstream using a proprietary method to measure markers at the protein level to deliver a robust and personalised risk score for cancer therapy guidance
Graph demonstrates Digistain ability to characterise previously unidentified low risk patients suitable for the safe avoidance of adjuvant chemotherapy
Scientific Summary
Following a period of extensive research and development in 2018 Digistain undertook a clinical validation study using biopsy samples from 801 early-stage HR+ breast cancer patients. The study was conducted in partnership with Nottingham University NHS Trust, the National Institute of Healthcare Research (NIHR) and Cancer Research UK.
The purpose was to assess the efficacy and reproducibility of Digistain’s technology in identifying low-risk candidates that could potentially forego adjuvant chemotherapy.
The study demonstrated that Digistain’s technology could identify cancer recurrence risk with equivalent reliability and accuracy to gold-standard NICE-approved traditional tumour profiling Next Generation Sequencing (NGS) tests in disease-free survival and overall survival prediction, with numerically equivalent sensitivity specificity and reproducibility.
The study supported Digistain’s proposition that its technology can provide a cost-effective way to identify low-risk patients who may forego adjuvant chemotherapy that is radically faster than current methods.
Digistain have secured Health Research Authority (HRA) approval for the clinical use in digital breast cancer decision support for a number of ongoing trials. Indications are that these trials further demonstrate that the technology can generate an objective diagnostic score for clinical decision support.
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