Certified under IVDR
Automated, accurate and objective
Manual exclusion of non-invasive tumor can in some specimens be challenging, even for an experienced pathologist. In cancers with a diffuse growth pattern, this can also be highly labor intensive.
With clinical breast cancer guidelines prescribing assessment of ER, PR, Ki-67, and HER2 on invasive cancers (ref. 1-3), the need for exclusion of noninvasive structures becomes essential. Biomarker analysis in hot spots is especially prone to bias by the non-invasive tumor.
The Invasive Tumor Detection APP automatically detects the invasive tumor. The algorithm integrates into a full biomarker analysis workflow, for automatic hot spot detection, accurate biomarker quantification, and visualization of tumor heterogeneity supporting the pathologist’s decisions.
Invasive tumor detection method
The Invasive Tumor Detection APP is based on a physical double stain of p63+CK7/19. Invasive tumor components are identified as regions positive for CK, whereas non-invasive tumor components are identified as regions positive for both CK and p63, and are excluded.
Biomarker assessment workflow
In combination with an analytical biomarker APP, the Invasive Tumor Detection APP provides an objective supplement to manual scoring. Results provided by both APPs must be confirmed by a qualified pathologist.
In the workflow illustrated above, serial sections of p63+CK7/19 and Ki-67 are virtually aligned. The p63+CK7/19 slide is evaluated for invasive and non-invasive tumor, which is transferred to the Ki-67 slide. Subsequent biomarker analysis within invasive tumor structures is accurate and according to clinical guidelines.
In EU/UK: CE IVD – for use in diagnostic procedures