Total submissions: 2
Submitter | RCV | SCV | Clinical significance | Condition | Last evaluated | Review status | Method | Comment |
---|---|---|---|---|---|---|---|---|
Clin |
RCV001794564 | SCV002032364 | pathogenic | Monogenic diabetes | 2021-08-24 | reviewed by expert panel | curation | The c.425C>T variant in the HNF1 homeobox A gene, HNF1A, causes an amino acid change of serine to phenylalanine at codon 142 (p.(Ser142Phe)) of NM_000545.8. This variant is located within the DNA binding domain (codons 107-174) of HNF1A, which is defined as critical for the protein’s function by the ClinGen MDEP (PM1_Supporting). This is supported by functional studies that demonstrated the p.Ser142Phe protein has DNA binding below 40% of wild type, indicating that this variant impacts protein function (PS3_Supporting, PMID: 10585442). This variant is also predicted to be deleterious by computational evidence, with a REVEL score of 0.977, which is greater than the MDEP threshold of 0.70 (PP3). This variant is absent in gnomAD v2.1.1 (PM2_Supporting), and was identified in at least 9 unrelated individuals with non- autoimmune and non-absolute/near-absolute insulin-deficient diabetes (PS4; PMID 31968686, PMID 9097962, PMID: 23610083, PMID: 21224407, internal lab contributors). This variant segregated with diabetes, with 14 informative meioses in 5 families with MODY (PP1_Strong; PMID 31968686, PMID 9097962, internal lab contributors). This variant was identified in an individual with diabetes with a calculated MODY probability of <50%, however the presence of a moderate level of criteria (persistent C-peptide) allows the application of this criteria at a supporting level per the ClinGen MDEP's approval (PP4; PMID 31968686). Taken together, this evidence supports the classification of this variant as pathogenic for monogenic diabetes. ACMG/AMP criteria applied (specification version 1.0, approved 8/24/21): PP1_Strong, PS4, PP3, PP4, PM1_Supporting, PM2_Supporting, PS3_Supporting. |
Revvity Omics, |
RCV003136157 | SCV003822784 | pathogenic | not provided | 2022-03-03 | criteria provided, single submitter | clinical testing |