title: Validation of an electronic program for pathologist training in the interpretation of a complex companion diagnostic immunohistochemical assay.
abstract: Companion diagnostics assay interpretation can select patients with the greatest targeted therapy benefits. We present the results from a prospective study demonstrating that pathologists can effectively learn immunohistochemical assay-interpretation skills from digital image-based electronic training (e-training). In this study, e-training was used to train board-certified pathologists to evaluate non-small cell lung carcinoma for eligibility for treatment with onartuzumab, a MET-inhibiting agent. The training program mimicked the live training that was previously validated in clinical trials for onartuzumab. A digital interface was developed for pathologists to review high-resolution, static images of stained slides. Sixty-four pathologists practicing in the United States enrolled while blinded to the type of training. After training, both groups completed a mandatory final test using glass slides. The results indicated both training modalities to be effective. Overall, 80.6% of e-trainees and 72.7% of live trainees achieved passing scores (at least 85%) on the final test. All study participants reported that their training experience was "good" and that they had received sufficient information to determine the adequacy of case slide staining to score each case. This study established that an e-training program conducted under highly controlled conditions can provide pathologists with the skills necessary to interpret a complex assay and that these skills can be equivalent to those achieved with face-to-face training using conventional microscopy. Programs of this type are scalable for global distribution and offer pathologists the potential for readily accessible and robust training in new companion diagnostic assays linked to novel, targeted, adjuvant therapies for cancer patients.
authors.affiliation: Ventana Medical Systems, Inc, a member of the Roche Group, Tucson, AZ 85755. Electronic address: eslie.dennis@roche.com.
authors.forename: Eslie
authors.initials: E
authors.lastname: Dennis
authors.affiliation: Ventana Medical Systems, Inc, a member of the Roche Group, Tucson, AZ 85755.
authors.forename: Peter
authors.initials: P
authors.lastname: Banks
authors.affiliation: Ventana Medical Systems, Inc, a member of the Roche Group, Tucson, AZ 85755.
authors.forename: Lauren B
authors.initials: LB
authors.lastname: Murata
authors.affiliation: Ventana Medical Systems, Inc, a member of the Roche Group, Tucson, AZ 85755.
authors.forename: Stephanie A
authors.initials: SA
authors.lastname: Sanchez
authors.affiliation: Ventana Medical Systems, Inc, a member of the Roche Group, Tucson, AZ 85755.
authors.forename: Christie
authors.initials: C
authors.lastname: Pennington
authors.affiliation: Ventana Medical Systems, Inc, a member of the Roche Group, Tucson, AZ 85755.
authors.forename: Linda
authors.initials: L
authors.lastname: Hockersmith
authors.affiliation: Ventana Medical Systems, Inc, a member of the Roche Group, Tucson, AZ 85755.
authors.forename: Rachel
authors.initials: R
authors.lastname: Miller
authors.affiliation: Ventana Medical Systems, Inc, a member of the Roche Group, Tucson, AZ 85755.
authors.forename: Jess
authors.initials: J
authors.lastname: Lambe
authors.affiliation: Ventana Medical Systems, Inc, a member of the Roche Group, Tucson, AZ 85755.
authors.forename: Janine
authors.initials: J
authors.lastname: Feng
authors.affiliation: Ventana Medical Systems, Inc, a member of the Roche Group, Tucson, AZ 85755.
authors.forename: Monesh
authors.initials: M
authors.lastname: Kapadia
authors.affiliation: Ventana Medical Systems, Inc, a member of the Roche Group, Tucson, AZ 85755.
authors.forename: June
authors.initials: J
authors.lastname: Clements
authors.affiliation: Ventana Medical Systems, Inc, a member of the Roche Group, Tucson, AZ 85755.
authors.forename: Isabell
authors.initials: I
authors.lastname: Loftin
authors.affiliation: Ventana Medical Systems, Inc, a member of the Roche Group, Tucson, AZ 85755.
authors.forename: Shalini
authors.initials: S
authors.lastname: Singh
authors.affiliation: F. Hoffmann La Roche, Ltd, 4070 Basel, Switzerland.
authors.forename: Ashis
authors.initials: A
authors.lastname: Das-Gupta
authors.affiliation: Custom Learning Designs, Inc, Belmont, MA 02478.
authors.forename: William
authors.initials: W
authors.lastname: Lloyd
authors.affiliation: Clarient Diagnostic Services, Inc, Aliso Viejo, CA 92656.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Bloom
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000627:therapeutic use; D014408:Biomarkers, Tumor / Q000032:analysis* / Q000037:antagonists & inhibitors; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000201:enzymology* / Q000473:pathology; D002983:Clinical Competence; D000066491:Clinical Decision-Making; D003196:Computer Graphics; D003194:Computer-Assisted Instruction; D003479:Curriculum; D004502:Education, Medical, Continuing / Q000379:methods*; D006801:Humans; D007150:Immunohistochemistry; D007318:Inservice Training / Q000379:methods*; D008175:Lung Neoplasms / Q000188:drug therapy / Q000201:enzymology* / Q000473:pathology; D008853:Microscopy; D010338:Pathology, Clinical / Q000193:education*; D018579:Patient Selection; D011237:Predictive Value of Tests; D015397:Program Evaluation; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D019859:Proto-Oncogene Proteins c-met / Q000032:analysis* / Q000037:antagonists & inhibitors; D015203:Reproducibility of Results; D014481:United States; D057188:Workflow
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D047428:Protein Kinase Inhibitors; C491743:MET protein, human; D019859:Proto-Oncogene Proteins c-met; C584058:onartuzumab
keywords: Companion diagnostics; Digital images; E-learning; Electronic training; Proficiency testing; Virtual pathology