Recurrence-risk information for clinicians
Digistain provides recurrence-risk information (within the next 10 years) for patients diagnosed with ER-positive, HER2-negative, Stage 1 or 2 invasive breast cancer with no more than 3 involved lymph nodes.
The technology is UKCA-marked and registered with the MHRA, developed with input from oncologists and clinical specialists, and clinically validated in a peer-reviewed study of 801 patients.
Digistain analyses tissue samples using infrared spectroscopy combined with a validated multivariate statistical model. It does not require RNA isolation.
Key features
Easy-to-read report providing post-surgical risk stratification that the multidisciplinary team considers alongside established clinico-pathological factors.
Provides additional prognostic information for consideration alongside established clinico-pathological factors
Profiles a tumour in with results returned quickly to support timely clinical decisions
Lower cost per biopsy test compared with genomic alternatives
Advanced quality management and seamless integration into existing pathology workflows
Digistain® Prognostic Score
Digistain analyses the infrared spectroscopic signature of tumour tissue. It does not require RNA isolation.
Digistain is designed to fit existing histopathology workflows.
Digistain has been evaluated in a retrospective validation study of 801 patients.
Rapid Risk Stratification
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Digistain Prognostic Score – Breast is an in vitro diagnostic test for professional use. The result is an estimate of the risk of recurrence and is probabilistic. It is used with, and does not replace, established clinico-pathological factors and clinical judgement. Treatment decisions remain with the treating clinician.