Acta Dermato-Venereologica 98-4CompleteContent | Page 13

INVESTIGATIVE REPORT 437 The Position of Targeted Next-generation Sequencing in Epidermo­ lysis Bullosa Diagnosis Cristina HAS 1 , Julia KÜSEL 2# , Antonia REIMER 1,3# , Julia HOFFMANN 1 , Franziska SCHAUER 1 , Andreas ZIMMER 2 and Judith FISCHER 2 Department of Dermatology, 2 Institute for Human Genetics, Medical Center, University of Freiburg, and 3 Berta-Ottenstein-Program, Faculty of Medicine, University of Freiburg, Freiburg, Germany # These authors contributed equally to this paper. 1 The precise classification of epidermolysis bullosa (EB) into 4 main types and more than 30 subtypes is based on the level of skin cleavage, as well as clinical and molecular features, and is crucial for early prognosti- cation, case management, genetic counselling and prenatal or pre-implantation diagnosis. We report here the molecular pathology of 40 consecutive cases of su- spected EB, which were investigated by immunofluo- rescence mapping (IFM) and/or by a targeted next- generation sequencing (NGS) multi-gene panel. IFM correctly established the EB subtype in 76% of cases, while the molecular pathology was completely eluci- dated in 90% of cases by the targeted NGS multi-gene panel. Thirteen previously unreported mutations in EB genes were identified. In cases with unclear clini- cal and IFM findings, mutations were found by NGS in previously unexpected genes. IFM was useful in deli- vering fast results in newborns, and in indicating the consequences of the variants of uncertain significance on protein level. This study underscores the efficacy of the strategy of combining targeted NGS with IFM in re- solving unusual EB phenotypes. It also suggests that, despite technological advances, careful clinical eva- luation and deep phenotyping remains a crucial factor that dictates successful diagnosis of EB. Key words: epidermolysis bullosa; adhesion; blistering; skin fragility; mutation; keratin; collagen. Accepted Dec 14, 2017; Epub ahead of print Dec 15, 2017 Acta Derm Venereol 2018; 98: 437–440. Corr: Cristina Has, Department of Dermatology, Medical Center, Universi­ ty of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstrasse 7, DE-79104 Freiburg, Germany. E-mail: [email protected] E pidermolysis bullosa (EB) is a clinically and geneti- cally heterogeneous group of disorders characterized by skin fragility and mechanically induced skin blistering. The genetic basis of EB is well-established (1), yet new genes and mutational mechanisms still emerge. Clas- sification of EB into 4 main types (simplex, junctional, dystrophic and Kindler syndrome) and more than 30 sub- types is based on immunofluorescence mapping (IFM) and mutation analysis (2). Precise classification is crucial for early prognostication, case management, genetic counsel- ling and prenatal or preimplantation diagnosis (2). Clas- sical types of EB, such as severe generalized dystrophic or junctional EB, can be recognized based on clinical criteria as soon as the clinical picture is fully manifest (3). In newborns, infants and in individuals with moderate or mild skin fragility, clinical assessment usually does not allow precise classification. Such cases require molecular and genetic diagnosis. We report here the molecular pathology of 40 conse- cutive suspected cases of EB, which were investigated by IFM and/or by a targeted next-generation sequencing (NGS) multi-gene panel since July 2016, when NGS was approved as a diagnostic method in Germany. METHODS IFM was performed with a panel of 17 antibodies to components of the dermal–epidermal junction, as described previously (4). The multi-gene panel included 49 genes: 19 genes in which mutations were shown to be disease-causing in EB (2), and 30 additional ge- nes functionally related to epidermal adhesion or potential genetic modifiers (Table SI 1 ). NGS was performed using a custom Agilent Haloplex panel (Agilent, Santa Clara, CA, USA) and sequences were determined with an Illumina MiSeq (2 × 150 base pairs; Illumina, San Diego, CA, USA). Paired-end sequencing reads were aligned using Burrows-Wheeler Alignment tool (5) (version 0.7.15) against the human reference genome sequence GRCh37 (hg19). Variants were called using FreeBayes (6) (v1.1.0). AN- NOVAR (ANNOtate VARiation) (7) was applied to annotate the function of genetic variants and to cross-reference the variants with databases. Only variants with a frequency of < 1% and homozy- gous absence in ExAC (8) v0.3 were considered. Mutations were confirmed by Sanger sequencing, and whenever possible, segrega- tion was verified in the families (primer sequences available on request). Direct and indirect immunofluorescence were performed as described previously (9, 10). Fluorescein (FITC)-labelled anti- bodies used for direct immunofluorescence were anti-human IgG, IgA, IgM and C3c (Dako, Hamburg, Germany) at a dilution of 1:200, 1:50, 1:50 and 1:500. For IIF on salt-split skin, patient sera were diluted 1:10, secondary antibodies used were FITC-labelled anti-human IgG (Dako, Hamburg, Germany) at a dilution of 1:100. Commercial enzyme-linked immunoassay (ELISA) kits for the detection of NC16A domain of BP180- and bullous pemphigoid 230-kDa antigen (BP230)-specific antibodies (MBL) were used as per manufacturer’s protocol, with cut-off at 9 U/ml. RESULTS Analysis of a skin biopsy by IFM was performed in 25 cases, and correctly established the EB subtype in 19 of these (76%). In 36 cases (90%) the molecular patho­logy https://www.medicaljournals.se/acta/content/abstract/10.2340/00015555-2863 1 This is an open access article under the CC BY-NC license. www.medicaljournals.se/acta Journal Compilation © 2018 Acta Dermato-Venereologica. doi: 10.2340/00015555-2863 Acta Derm Venereol 2018; 98: 437–440