Objective: Digistain is a new technology platform that enables imaging
and quantification of a newly conceived biomarker for grading breast
carcinoma in routinely processed, unstained paraffin sections without
the use of traditional stains or contrasting agents. By recording a unique
optical signature to analyze the chemical make-up of a biopsy quantitatively, the technique is unaffected by the subjectivity of traditional grading. Within minutes of loading a slide it yields a highly reproducible and user independent numerical score reflecting the cellularity of the tumour and its nuclear: cytoplasmic ratio. We report here our findings using an objective technique to grade breast tumours using quantitative criteria.
Method: H&E stained sections from excision biopsies of 105 cases of
invasive breast carcinoma were reviewed and graded using the ElstonEllis
grading system. Unstained sections from each case were loaded into
the Digistain platform to yield a numerical score - the Digistain Index
(DI).
Results: The cases were grouped according to histological grading. Mean
DIs was calculated for each grade (1,2 and 3) to be 0.56, 0.61, and 0.68
respectively with a maximum standard error of 0.02. The DI spread within
each grade was less than that across the three grades, thus validating
this index as a viable grading indicator within the context of this study.
Conclusion: We believe the new Digistain approach provides for the first
time a cost effective and quantitative measure of tumour grade. This can
be developed to deliver an effective assessment of prognosis and recurrence risk beyond traditional qualitative measures based on H&E staining protocols.