Total submissions: 9
Submitter | RCV | SCV | Clinical significance | Condition | Last evaluated | Review status | Method | Comment |
---|---|---|---|---|---|---|---|---|
Clin |
RCV000237360 | SCV002506358 | pathogenic | Hypercholesterolemia, familial, 1 | 2022-04-05 | reviewed by expert panel | curation | PP1_strong: Variant segregates with FH phenotype in at least 28 informative meiosis (minimum 2) from 9 families from different labs (Laboratory of Genetics and Molecular Cardiology). PS3: PMID: 32015373. Level 1 assay. Heterologous cells (CHO), FACS assays. Normal cell surface LDLR (90%), 50% binding and 48% uptake. PS4_supporting: variant meets PM2 and is identified in 1 index case who fulfills SB criteria of definite FH from Molecular Genetics Laboratory (Centre for Cardiovascular Surgery and Transplantation) and 1 index case with DLCN >6 from PMID 30270055, Corral et al., 2018 (Argentina) so PS4_Supporting is met PM2: No population data was found for this variant in gnomAD (gnomAD version 2.1.1). PP3: REVEL = 0.927. PP4: Variant meets PM2 and is identified in 1 index case who fulfils SB for FH from different labs (Molecular Genetics Laboratory (Centre for Cardiovascular Surgery and Transplantation) and Laboratory of Genetics and Molecular Cardiology). |
LDLR- |
RCV000237360 | SCV000295122 | likely pathogenic | Hypercholesterolemia, familial, 1 | 2016-03-25 | criteria provided, single submitter | literature only | |
Molecular Genetics Laboratory, |
RCV000237360 | SCV000540779 | likely pathogenic | Hypercholesterolemia, familial, 1 | 2016-11-05 | criteria provided, single submitter | clinical testing | |
Laboratory of Genetics and Molecular Cardiology, |
RCV000237360 | SCV000588537 | likely pathogenic | Hypercholesterolemia, familial, 1 | 2016-03-01 | criteria provided, single submitter | research | |
Iberoamerican FH Network | RCV000237360 | SCV000748091 | likely pathogenic | Hypercholesterolemia, familial, 1 | 2016-03-01 | criteria provided, single submitter | research | |
Labcorp Genetics |
RCV001387171 | SCV001587731 | pathogenic | Familial hypercholesterolemia | 2024-08-01 | criteria provided, single submitter | clinical testing | This sequence change replaces serine, which is neutral and polar, with cysteine, which is neutral and slightly polar, at codon 326 of the LDLR protein (p.Ser326Cys). This variant is not present in population databases (gnomAD no frequency). This missense change has been observed in individuals with familial hypercholesterolemia (PMID: 12820708, 23375686, 23815734, 25463123). This variant is also known as S305C. ClinVar contains an entry for this variant (Variation ID: 251581). Advanced modeling of protein sequence and biophysical properties (such as structural, functional, and spatial information, amino acid conservation, physicochemical variation, residue mobility, and thermodynamic stability) performed at Invitae indicates that this missense variant is expected to disrupt LDLR protein function with a positive predictive value of 95%. This variant disrupts the p.Ser326 amino acid residue in LDLR. Other variant(s) that disrupt this residue have been observed in individuals with LDLR-related conditions (PMID: 11668640), which suggests that this may be a clinically significant amino acid residue. For these reasons, this variant has been classified as Pathogenic. |
Fulgent Genetics, |
RCV000237360 | SCV002788296 | likely pathogenic | Hypercholesterolemia, familial, 1 | 2021-10-22 | criteria provided, single submitter | clinical testing | |
GENin |
RCV001387171 | SCV005622679 | pathogenic | Familial hypercholesterolemia | 2025-01-09 | criteria provided, single submitter | clinical testing | The LDLR c.977C>G p.(Ser326Cys) missense variant has been reported in at least 4 unrelated FH probands meeting clinical criteria, including patients where alternative causes of high cholesterol were excluded (PS4_SUPPORTING, PP4_SUPPORTING; PMIDs 23375686, 22698793, 30270055, ClinGen FH VCEP data) and has been seen to segregate with FH phenotype in >=6 informative meiosis (PP1_STRONG; ClinGen FH VCEP data, PMID: 23815734). This variant is absent from gnomAD v2.1.1 (PM2_MODERATE). This variant meets level 1 pathogenic functional study criteria with <70% of wild-type activity in LDL binding and LDL internalisation in heterologous cells (CHO) (PS3_STRONG; PMID: 32015373). REVEL score is 0.927 (PP3_SUPPORTING). Based on the evidence listed above, we have classified this variant as Pathogenic. |
Laboratorium voor Moleculaire Diagnostiek Experimentele Vasculaire Geneeskunde, |
RCV000237360 | SCV000606287 | pathogenic | Hypercholesterolemia, familial, 1 | no assertion criteria provided | research |