Clinical Overview

Fast accurate decision making for your patients​

Fast accurate decision-making for your patients

Digistain provides clinicians with a very fast way to identify the risk of breast cancer recurrence within the next 5-10 years for patients diagnosed with invasive breast cancer who are Stage 1 or 2, HER2-, ER+ or equal to or less than 3 malignant lymph nodes.

The MHRA-cleared technology has been developed with input from over 1500 oncologists and successfully trialled in leading cancer centres demonstrating gold-standard equivalency to NICE-approved traditional tumour profiling tests. 
Unlike genomic tests, Digistain measures markers at the protein level using a unique combination of optical scan technology and AI. It, therefore, avoids the quality control and reproducibility issues common to RNA isolation from formalin-fixed tissue.

Key features

  • Easy-to-read actionable report to guide adjuvant chemotherapy treatment decision making
  • Predicts individual patient risk when treated with endocrine therapy alone
  • Profiles a tumour in minutes with results returned very quickly so that information can be acted upon before a patient even leaves hospital
  • Dramatically lowers the cost per biopsy test
  • Advanced quality management and seamless integration into existing pathology workflows
Reduction in patient waiting times
0 %
Overall cost reduction through avoided chemotherapy
0 %
Multi-site reproducibility with routinely trained lab technicians
0 %

Digistain® Prognostic Score

Unlike first-generation genomic tests used in hospitals around the world today, Digistain® works biologically downstream to measure markers at the protein level. It, therefore, avoids the quality control and reproducibility issues common to RNA isolation from formalin-fixed tissue.

The advantage of working downstream is that Digistain’s unique approach is much closer to the patient outcome than biologically upstream laboratory protocols and is robust to clinical protocol variabilities.
In a recent landmark trial of over 801 patients, Digistain’s Prognostic Score demonstrated unequivocal equivalence to the best-in-class genomics tests in use today.
Digistain Test report 2022 12 30T19:32:11Z
Digistain® has undergone several clinical trials demonstrating a prognostic score with risk classification equivalent to the best in class genomic tests
The product of 15 years of R&D pioneered by respected cancer researchers from Imperial College London and Cancer Research UK
Digistain's Prognostic Score uses a proprietary optical scan of the tumour to capture a spectral signature (of over 10,000 data points) that is unique to every patient.
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