Scientific Overview
Digistain® analyses the infrared spectroscopic signature of tumour tissue to provide recurrence-risk information
Graph demonstrates Digistain ability to Kaplan-Meier curves by Digistain risk group in the 801-patient validation cohort
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 ER-positive breast cancer patients. The study was conducted in partnership with Nottingham University NHS Trust, the National Institute for Health and Care Research (NIHR) and Cancer Research UK.
The study evaluated the prognostic performance of Digistain in 801 patients with early-stage ER-positive breast cancer. It was not designed to test chemotherapy omission.
It reports hazard ratios for recurrence-free survival between Digistain risk groups in its intended population.
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