CONTEXT: Aperio Technologies, Inc (Vista, California) provides a new immunohistochemistry (IHC) HER2 Image Analysis (IA) system that allows tuning of the intensity thresholds of the HER2/ neu scoring scheme to adapt to the staining characteristics of different reagents. OBJECTIVE: To compare the trainable IHC HER2 IA system for different reagents to conventional manual microscopy (MM) in a multisite study. DESIGN: Two hundred sixty formalin-fixed, paraffin-embedded breast cancer specimens from 3 clinical sites were assayed: 180 specimens stained with Dako's HercepTest (Carpinteria, California), and 80 specimens stained with Ventana's PATHWAY HER-2/neu (Tucson, California). At each site, 3 pathologists performed a blinded reading of the glass slides with the use of a light microscope. The glass slides were then scanned and after a wash-out period and randomization, the same pathologists outlined a representative set of tumor regions to be analyzed by IHC HER2 IA. Each of the methods, MM and IA, was evaluated separately and comparatively by using κ statistics of negative HER2/neu scores (0, 1+) versus equivocal HER2/neu scores (2+) versus positive HER2/neu scores (3+) among the different pathologists. RESULTS: κ Values for IA and MM were obtained across all sites. MM: 0.565-0.864; IA: 0.895-0.947; MM versus IA: 0.683-0.892 for site 1; MM: 0.771-0.837; IA: 0.726-0.917; MM versus IA: 0.687-0.877 for site 2; MM: 0.463-0.674; IA: 0.864-0.918; MM versus IA: 0.497-0.626 for site 3. CONCLUSION: Aperio's trainable IHC HER2 IA system shows substantial equivalence to MM for Dako's HercepTest and Ventana's PATHWAY HER-2/neu at 3 clinical sites. Image analysis improved interpathologist agreement in the different clinical sites.
CONTEXT: Aperio Technologies, Inc (Vista, California) provides a new immunohistochemistry (IHC) HER2 Image Analysis (IA) system that allows tuning of the intensity thresholds of the HER2/ neu scoring scheme to adapt to the staining characteristics of different reagents. OBJECTIVE: To compare the trainable IHC HER2 IA system for different reagents to conventional manual microscopy (MM) in a multisite study. DESIGN: Two hundred sixty formalin-fixed, paraffin-embedded breast cancer specimens from 3 clinical sites were assayed: 180 specimens stained with Dako's HercepTest (Carpinteria, California), and 80 specimens stained with Ventana's PATHWAY HER-2/neu (Tucson, California). At each site, 3 pathologists performed a blinded reading of the glass slides with the use of a light microscope. The glass slides were then scanned and after a wash-out period and randomization, the same pathologists outlined a representative set of tumor regions to be analyzed by IHC HER2 IA. Each of the methods, MM and IA, was evaluated separately and comparatively by using κ statistics of negative HER2/neu scores (0, 1+) versus equivocal HER2/neu scores (2+) versus positive HER2/neu scores (3+) among the different pathologists. RESULTS: κ Values for IA and MM were obtained across all sites. MM: 0.565-0.864; IA: 0.895-0.947; MM versus IA: 0.683-0.892 for site 1; MM: 0.771-0.837; IA: 0.726-0.917; MM versus IA: 0.687-0.877 for site 2; MM: 0.463-0.674; IA: 0.864-0.918; MM versus IA: 0.497-0.626 for site 3. CONCLUSION: Aperio's trainable IHC HER2 IA system shows substantial equivalence to MM for Dako's HercepTest and Ventana's PATHWAY HER-2/neu at 3 clinical sites. Image analysis improved interpathologist agreement in the different clinical sites.
Authors: Marilyn M Bui; Michael W Riben; Kimberly H Allison; Elizabeth Chlipala; Carol Colasacco; Andrea G Kahn; Christina Lacchetti; Anant Madabhushi; Liron Pantanowitz; Mohamed E Salama; Rachel L Stewart; Nicole E Thomas; John E Tomaszewski; M Elizabeth Hammond Journal: Arch Pathol Lab Med Date: 2019-01-15 Impact factor: 5.534
Authors: Marios A Gavrielides; Catherine Conway; Neil O'Flaherty; Brandon D Gallas; Stephen M Hewitt Journal: Anal Cell Pathol (Amst) Date: 2014-11-11 Impact factor: 2.916
Authors: Tyler Keay; Catherine M Conway; Neil O'Flaherty; Stephen M Hewitt; Katherine Shea; Marios A Gavrielides Journal: J Pathol Inform Date: 2013-07-31
Authors: William J Howat; Fiona M Blows; Elena Provenzano; Mark N Brook; Lorna Morris; Patrycja Gazinska; Nicola Johnson; Leigh-Anne McDuffus; Jodi Miller; Elinor J Sawyer; Sarah Pinder; Carolien H M van Deurzen; Louise Jones; Reijo Sironen; Daniel Visscher; Carlos Caldas; Frances Daley; Penny Coulson; Annegien Broeks; Joyce Sanders; Jelle Wesseling; Heli Nevanlinna; Rainer Fagerholm; Carl Blomqvist; Päivi Heikkilä; H Raza Ali; Sarah-Jane Dawson; Jonine Figueroa; Jolanta Lissowska; Louise Brinton; Arto Mannermaa; Vesa Kataja; Veli-Matti Kosma; Angela Cox; Ian W Brock; Simon S Cross; Malcolm W Reed; Fergus J Couch; Janet E Olson; Peter Devillee; Wilma E Mesker; Caroline M Seyaneve; Antoinette Hollestelle; Javier Benitez; Jose Ignacio Arias Perez; Primitiva Menéndez; Manjeet K Bolla; Douglas F Easton; Marjanka K Schmidt; Paul D Pharoah; Mark E Sherman; Montserrat García-Closas Journal: J Pathol Clin Res Date: 2014-12-04