Total submissions: 10
Submitter | RCV | SCV | Clinical significance | Condition | Last evaluated | Review status | Method | Comment |
---|---|---|---|---|---|---|---|---|
Invitae | RCV001564388 | SCV000544282 | uncertain significance | not provided | 2022-11-01 | criteria provided, single submitter | clinical testing | This sequence change replaces valine, which is neutral and non-polar, with methionine, which is neutral and non-polar, at codon 435 of the FH protein (p.Val435Met). This variant is present in population databases (rs147528200, gnomAD 0.06%). This variant has not been reported in the literature in individuals affected with FH-related conditions. ClinVar contains an entry for this variant (Variation ID: 134418). 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 FH protein function. In summary, the available evidence is currently insufficient to determine the role of this variant in disease. Therefore, it has been classified as a Variant of Uncertain Significance. |
Ambry Genetics | RCV000571469 | SCV000673360 | likely benign | Hereditary cancer-predisposing syndrome | 2022-04-26 | criteria provided, single submitter | clinical testing | This alteration is classified as likely benign based on a combination of the following: seen in unaffected individuals, population frequency, intact protein function, lack of segregation with disease, co-occurrence, RNA analysis, in silico models, amino acid conservation, lack of disease association in case-control studies, and/or the mechanism of disease or impacted region is inconsistent with a known cause of pathogenicity. |
Gene |
RCV001564388 | SCV001787547 | uncertain significance | not provided | 2023-10-20 | criteria provided, single submitter | clinical testing | In silico analysis supports that this missense variant has a deleterious effect on protein structure/function; Observed in individuals with colorectal cancer or endocrine tumors as well as unaffected controls (PMID: 24728327, 29684080, 32808982, 32008151); This variant is associated with the following publications: (PMID: 32008151, 32561076, 25004247, 29641532, 24728327, 27377421, 29684080, 32808982, 37569332) |
Center for Genomic Medicine, |
RCV000121094 | SCV004025209 | uncertain significance | not specified | 2023-08-15 | criteria provided, single submitter | clinical testing | |
St. |
RCV003325184 | SCV004031172 | uncertain significance | Hereditary leiomyomatosis and renal cell cancer | 2023-05-31 | criteria provided, single submitter | clinical testing | The FH c.1303G>A (p.Val435Met) missense change has a maximum subpopulation frequency of 0.06% in gnomAD v2.1.1 (https://gnomad.broadinstitute.org). The in silico tool REVEL predicts a deleterious effect on protein function, but to our knowledge this prediction has not been confirmed by functional studies. To our knowledge, this variant has not been reported in individuals with hereditary leiomyomatosis and renal cell cancer (HLRCC) or fumarase deficiency. In summary, the evidence currently available is insufficient to determine the clinical significance of this variant. It has therefore been classified as of uncertain significance. |
Prevention |
RCV004555537 | SCV004114474 | uncertain significance | FH-related disorder | 2023-12-29 | criteria provided, single submitter | clinical testing | The FH c.1303G>A variant is predicted to result in the amino acid substitution p.Val435Met. This variant has been reported as a germline variant in patient with Cushing syndrome due to bilateral adrenocortical hyperplasia or adenoma (Berthon et al. 2020. PubMed ID: 32808982). This variant is reported in 0.060% of alleles in individuals of African descent in gnomAD (http://gnomad.broadinstitute.org/variant/1-241663824-C-T) and has conflicting interpretations of likely benign and uncertain in ClinVar (https://www.ncbi.nlm.nih.gov/clinvar/variation/134418/). Although we suspect that this variant may be benign, at this time, the clinical significance of this variant is uncertain due to the absence of conclusive functional and genetic evidence. |
Quest Diagnostics Nichols Institute San Juan Capistrano | RCV001564388 | SCV004218871 | likely benign | not provided | 2022-11-01 | criteria provided, single submitter | clinical testing | |
Baylor Genetics | RCV000473170 | SCV005057744 | uncertain significance | Fumarase deficiency | 2024-03-22 | criteria provided, single submitter | clinical testing | |
ITMI | RCV000121094 | SCV000085262 | not provided | not specified | 2013-09-19 | no assertion provided | reference population | |
Natera, |
RCV000473170 | SCV001457337 | uncertain significance | Fumarase deficiency | 2020-09-16 | no assertion criteria provided | clinical testing |