Multicenter Evaluation of the Fully Automated PCR-Based Idylla EGFR Mutation Assay on Formalin-Fixed, Paraffin-Embedded Tissue of Human Lung Cancer.

Before initiating treatment of advanced non-small-cell lung cancer with tyrosine kinase inhibitors (eg, erlotinib, gefitinib, osimertinib, and afatinib), which inhibit the catalytic activity of epidermal growth factor receptor (EGFR), clinical guidelines require determining the EGFR mutational status for activating (EGFR exons 18, 19, 20, or 21) and resistance (EGFR exon 20) mutations. The EGFR resistance mutation T790M should be monitored at cancer progression. The Idylla EGFR Mutation Assay, performed on the Idylla molecular diagnostics platform, is a fully automated (<2.5 hours turnaround time) sample-to-result molecular test to qualitatively detect 51 EGFR oncogene point mutations, deletions, or insertions. In a 15-center evaluation, Idylla results on 449 archived formalin-fixed, paraffin-embedded tissue sections, originating from non-small-cell lung cancer biopsies and resection specimens, were compared with data obtained earlier with routine reference methods, including next-generation sequencing, Sanger sequencing, pyrosequencing, mass spectrometry, and PCR-based assays. When results were discordant, a third method of analysis was performed, when possible, to confirm test results. After confirmation testing and excluding invalids/errors and discordant results by design, a concordance of 97.6% was obtained between Idylla and routine test results. Even with <10 mm2 of tissue area, a valid Idylla result was obtained in 98.9% of the cases. The Idylla EGFR Mutation Assay enables sensitive detection of most relevant EGFR mutations in concordance with current guidelines, with minimal molecular expertise or infrastructure.

Selective shunting during carotid endarterectomy.

Carotid endarterectomy (CEA) is an effective treatment for significant carotid atherosclerosis. Perioperative stroke, a devastating complication, may be partially circumvented by shunting. However, routine shunt use is not without complications and does not benefit every patient. Our study is designed to determine whether CEA under general anesthesia, without cerebral monitoring, can be safely done with shunting only in the presence of poor internal carotid artery back-bleeding or contralateral carotid occlusion or critical stenosis. The medical records of 995 carotid operations were reviewed. A subset of 117 operations was performed on 112 patients using selective shunting. Data were analyzed and outcomes compared. For the selective shunt group, indications for redo operations (n=13) were recurrent asymptomatic high-grade stenosis in 69% and amaurosis fugax or transient ischemic attack in 31%. Indications for primary CEA (n=104) were asymptomatic high-grade stenosis in 59%, amaurosis fugax or transient ischemic attack in 36%, previous stroke in 3%, and global ischemia in 2%. A selective shunt was used in 29% of all symptomatic and 11% of all asymptomatic patients. No cerebral monitoring was used. There were no perioperative deaths and no permanent cranial nerve injuries, and there was one stroke (0.8%) from postoperative carotid thrombosis in a shunted patient. The average length of stay was 1.6 days for the non-shunt group and 2.2 days for the shunt group. The routine shunt group (n=878) had an overall stroke rate of 0.7%, no permanent cranial nerve deficits, and a mean hospital stay of 2.6 days. CEA under general anesthesia with selective shunting can be performed safely without cerebral monitoring.