Next-Generation Sequencing Identifies Monogenic Diabetes
|
By LabMedica International staff writers Posted on 23 Jul 2019 |

Image: The MiSeq System: access focused applications such as targeted resequencing, metagenomics, small genome sequencing, targeted gene expression profiling (Photo courtesy of Illumina).
Monogenic diabetes is seen mainly in maturity onset diabetes of the young (MODY), and accounts for 1%–2% of all diabetes cases. In adults, monogenic diabetes is difficult to distinguish from common diabetes causes.
The diagnosis of monogenic diabetes is an example of precision medicine because it conveys specificities as regards the severity and the course of hyperglycemia, the risk of diabetes complications, the need for diabetes treatment and its modalities, the presence of associated features, and the management of affected women during pregnancy.
Medical Geneticists at the Pitié-Salpêtrière Hospital (Paris, France) and their colleagues included in a cross-sectional study 1,564 probands who were recruited from 116 Endocrinology departments throughout France. Inclusion criteria were the absence of diabetes autoantibodies, and at least two of the three following criteria: an age ≤ 40 years and a body mass index (BMI) < 30 kg/m2 at diagnosis in the proband or in at least two relatives with diabetes, and a family history of diabetes in ≥ 2 generations.
Genetic testing was carried out in two steps. The first one was the targeted Next-Generation Sequencing (NGS) based on a multiplex polymerase chain reaction assay, the SureMODY-MASTR assay. The coding regions ± 30 bp of seven genes (GCK, HNF1A, HNF4A, HNF1B, ABCC8, KCNJ11, and INS) and the minimal promoter region of HNF1A, HNF4A, and INS were amplified, and multiplex libraries were subsequently pooled and run on a MiSeq instrument.
The scientists reported that pathogenic variants were identified in 254 patients (16.2%) and in 23.2% of EuroCaucasian patients. Using more stringent selection criteria (family history of diabetes in ≥ 3 generations, age at diabetes ≤ 40 years and BMI < 30 kg/m2 in the proband, EuroCaucasian origin) increased the diagnosis rate to 43%, but with 70% of the identified cases being missed. GCK (44%), HNF1A (33%), and HNF4A (10%) accounted for the majority of the cases. HNF1B (6%), ABCC8/KCNJ11 (4.4%), and INS (2.8%) variants accounted for 13% of the cases.
As compared to non-monogenic cases, a younger age, a lower BMI and the absence of diabetes symptoms at diagnosis, a EuroCaucasian origin, and a family history of diabetes in ≥ 3 generations were associated with monogenic diabetes, but with wide phenotype overlaps between the two groups. In the total population, two clusters were identified, that mainly differed by the severity of diabetes at onset. Monogenic diabetes was more prevalent in the milder phenotypic cluster. The phenotypes of the 59 patients (3.8%) with variants of uncertain significance were different from that of patients with pathogenic variants, but not from that of non-monogenic patients.
The authors concluded that variants of HNF1B and the K-ATP channel genes were more frequently involved in monogenic diabetes than previously reported. Phenotype overlapping makes the diagnosis of monogenic diabetes difficult in adolescents/adults and underlies the benefit of NGS in clinically selected patients. The study was published on July 11, 2019, in the journal BMC Medicine.
Related Links:
Pitié-Salpêtrière Hospital
The diagnosis of monogenic diabetes is an example of precision medicine because it conveys specificities as regards the severity and the course of hyperglycemia, the risk of diabetes complications, the need for diabetes treatment and its modalities, the presence of associated features, and the management of affected women during pregnancy.
Medical Geneticists at the Pitié-Salpêtrière Hospital (Paris, France) and their colleagues included in a cross-sectional study 1,564 probands who were recruited from 116 Endocrinology departments throughout France. Inclusion criteria were the absence of diabetes autoantibodies, and at least two of the three following criteria: an age ≤ 40 years and a body mass index (BMI) < 30 kg/m2 at diagnosis in the proband or in at least two relatives with diabetes, and a family history of diabetes in ≥ 2 generations.
Genetic testing was carried out in two steps. The first one was the targeted Next-Generation Sequencing (NGS) based on a multiplex polymerase chain reaction assay, the SureMODY-MASTR assay. The coding regions ± 30 bp of seven genes (GCK, HNF1A, HNF4A, HNF1B, ABCC8, KCNJ11, and INS) and the minimal promoter region of HNF1A, HNF4A, and INS were amplified, and multiplex libraries were subsequently pooled and run on a MiSeq instrument.
The scientists reported that pathogenic variants were identified in 254 patients (16.2%) and in 23.2% of EuroCaucasian patients. Using more stringent selection criteria (family history of diabetes in ≥ 3 generations, age at diabetes ≤ 40 years and BMI < 30 kg/m2 in the proband, EuroCaucasian origin) increased the diagnosis rate to 43%, but with 70% of the identified cases being missed. GCK (44%), HNF1A (33%), and HNF4A (10%) accounted for the majority of the cases. HNF1B (6%), ABCC8/KCNJ11 (4.4%), and INS (2.8%) variants accounted for 13% of the cases.
As compared to non-monogenic cases, a younger age, a lower BMI and the absence of diabetes symptoms at diagnosis, a EuroCaucasian origin, and a family history of diabetes in ≥ 3 generations were associated with monogenic diabetes, but with wide phenotype overlaps between the two groups. In the total population, two clusters were identified, that mainly differed by the severity of diabetes at onset. Monogenic diabetes was more prevalent in the milder phenotypic cluster. The phenotypes of the 59 patients (3.8%) with variants of uncertain significance were different from that of patients with pathogenic variants, but not from that of non-monogenic patients.
The authors concluded that variants of HNF1B and the K-ATP channel genes were more frequently involved in monogenic diabetes than previously reported. Phenotype overlapping makes the diagnosis of monogenic diabetes difficult in adolescents/adults and underlies the benefit of NGS in clinically selected patients. The study was published on July 11, 2019, in the journal BMC Medicine.
Related Links:
Pitié-Salpêtrière Hospital
Latest Pathology News
- Breakthrough-Designated Cytology Test Supports Oral Cancer Risk Assessment
- Review Highlights Progress and Validation Needs for AI in Digital Pathology
- Roche Launches Automated Test to Support Mesothelioma Differential Diagnosis
- AI Pathology Approach Closely Aligns With Breast Cancer Genomic Risk Classification
- Digital Pathology Test Stratifies Recurrence Risk in Early Breast Cancer
- AI Pathology Tool Predicts DNA Repair Deficiency in High-Grade Serous Ovarian Cancer
- AI Tissue Analysis May Help Identify Missed Precancerous Colon Polyps
- AI Pre-Screening Helps Identify Lung Cancer Cases for Additional Biomarker Testing
- AI Pathology Platform Targets Workflow Delays and Molecular Test Failures
- Updated Digital Pathology Platform Expands AI Integration for Cancer Diagnosis
- Molecular Testing Refines Barrett’s Esophagus Progression Risk Beyond Biopsy Findings
- AI Histopathology Tool Distinguishes Ewing Sarcoma for Diagnosis
- Rapid Mass Spectrometry Test May Aid Glioma Margin Decisions
- Genomic Classifier Predicts Benefit From Adding Hormone Therapy to Salvage Prostate Radiation
- Multimodal AI Supports Prostate Cancer Risk Assessment Across Diverse Cohorts
- New AI Model Maps Where Glioblastoma Could Return After Surgery
Channels
Clinical Chemistry
view channel
Blood Protein Panel Detects ALS with High Accuracy
Amyotrophic lateral sclerosis (ALS) is a progressive neurological disease that affects the nerve cells responsible for muscle movement. Early symptoms, including muscle weakness, cramps, and difficulty... Read more
Single-Vesicle Analysis Reveals Tissue-Associated Inflammatory Signatures
Chronic inflammation can persist for months or years when immune cells continue attacking tissues despite the absence of an active threat. It is associated with cancers, brain disorders, autoimmune diseases,... Read moreHematology
view channel
New Reference Ranges Clarify Normal Neutrophil Counts in Duffy-Null Patients
Duffy-null status is a common genetic trait associated with naturally lower circulating white blood cell counts. It affects about 10% of the U.S. population and more than 66% of people with African or... Read more
Newly Certified FISH Probes Support Cytogenetic Testing in Blood Cancers
Hematological malignancies such as non-Hodgkin lymphoma, acute lymphoblastic leukemia, chronic lymphoid leukemia, and multiple myeloma require assessment of key cytogenetic abnormalities.... Read more
Genetic Testing Offers Opportunities for Earlier Blood Disorder Carrier Identification
Inherited hemoglobin disorders can affect oxygen transport, yet individuals who carry only a trait may remain unaware of their status. People with sickle cell trait or beta-thalassemia trait often have... Read more
New Risk-Stratification Tool Predicts Relapse After Blinatumomab in Childhood ALL
Acute lymphoblastic leukemia in children and young people requires careful assessment of relapse risk, particularly as treatment approaches move beyond standard chemotherapy. Traditional relapse predictors... Read moreImmunology
view channel
Exhaled Breath Particles Reveal Virus-Specific Antibodies in the Lower Airways
Respiratory viruses such as influenza virus, SARS-CoV-2, and respiratory syncytial virus (RSV) require immune protection across the airway mucosa. Antibodies in the respiratory tract lining are important... Read more
Roche Gains FDA Clearance for Flexible Respiratory Pathogen Panel
Respiratory infections often cause overlapping viral and bacterial symptoms, making diagnosis more difficult during peak respiratory seasons. This uncertainty can be especially important for high-risk... Read more
Tumor and Immune Biomarkers Linked to Treatment Response in T-Cell Lymphoma
T-follicular helper cell lymphoma (TFHL) is a subtype of peripheral T-cell lymphoma associated with poor prognosis and limited treatment options after relapse. Its molecular abnormalities include frequent... Read more
Prototype Point-of-Care Lateral Flow Test Aims to Improve Neonatal Sepsis Triage
Sepsis in newborns and young infants remains a major clinical challenge, particularly in low- and middle-income countries. An estimated 2.3 million newborns die each year, with sepsis contributing substantially... Read moreMicrobiology
view channel
Common Genetic Variant Increases Risk of Bacterial Pneumonia
Pneumonia is a common and sometimes serious infection, with 20,000–30,000 people affected in Sweden each year. Known risk factors include advanced age, smoking, and underlying medical conditions.... Read more
Stool Testing Predicts UTI Risk and Guides Antibiotic Selection
Urinary tract infections (UTIs) are a common reason for antibiotic prescribing in general medical practice and can be painful in postmenopausal women, sometimes progressing to kidney infection or life-threatening... Read more
Rapid Host-Response Assay Gains FDA Clearance to Help Distinguish Bacterial and Viral Infections
Bacterial and viral infections often cause similar symptoms, making early differentiation difficult in emergency and urgent care settings. Clinicians may need to begin treatment before traditional diagnostic... Read morePathology
view channel
Review Highlights Progress and Validation Needs for AI in Digital Pathology
Pathology remains the gold standard for disease diagnosis, but clinical laboratories face growing demands for faster, more reproducible diagnostic and prognostic workflows. Digital pathology based on whole-slide... Read more
Breakthrough-Designated Cytology Test Supports Oral Cancer Risk Assessment
Oral cavity and oropharyngeal cancers remain a significant diagnostic challenge, with more than 60,000 Americans expected to be diagnosed in 2026 and more than 13,000 expected to die from these cancers.... Read more
AI Pathology Approach Closely Aligns With Breast Cancer Genomic Risk Classification
In early-stage breast cancer, precision oncology relies on biological information to guide personalized treatment decisions. Because access to tissue-based genomic testing may be limited, there is growing... Read moreTechnology
view channel
New qPCR Master Mixes Offer Broad Compatibility for Routine Research
Quantitative PCR (qPCR) workflows require consistent reagent performance across instruments and assay formats. Laboratories must also manage costs without changing established protocols.... Read more
Multi-Agent AI Framework Supports Laboratory Quality and Workflow Monitoring
Clinical laboratories analyze blood, urine, tissue, and other bodily fluids to support disease diagnosis and treatment. Rising test volumes, workforce shortages, and increasingly complex diagnostics are... Read moreIndustry
view channel
Siemens Healthineers Begins Transition Toward Standalone Olyrian Diagnostics Business
Siemens Healthineers has begun carving out its in vitro diagnostics business, which will operate as Olyrian Diagnostics. The new name will be introduced in stages as the business prepares to become a standalone... Read more
Agilent Completes Acquisition of Digital Pathology Platform Developer Proscia
Agilent Technologies has completed its acquisition of Proscia, a provider of digital pathology software for clinical and life sciences applications. The transaction involved a cash payment of USD 240 million... Read more
New Diagnostics Company Onvaro Formed to Expand Decentralized Testing
Sapphiros, a diagnostics platform backed by investment funds managed by KKR, and binx health, a point-of-care diagnostics company backed by Hildred, have combined to form Onvaro. The new diagnostics company... Read more







