Total submissions: 5
Submitter | RCV | SCV | Clinical significance | Condition | Last evaluated | Review status | Method | Comment |
---|---|---|---|---|---|---|---|---|
Labcorp Genetics |
RCV000532647 | SCV000632643 | uncertain significance | GNE myopathy; Sialuria | 2021-08-28 | criteria provided, single submitter | clinical testing | This sequence change affects codon 458 of the GNE mRNA. It is a 'silent' change, meaning that it does not change the encoded amino acid sequence of the GNE protein. This variant also falls at the last nucleotide of exon 7, which is part of the consensus splice site for this exon. This variant is not present in population databases (ExAC no frequency). This variant has not been reported in the literature in individuals affected with GNE-related conditions. ClinVar contains an entry for this variant (Variation ID: 460451). Variants that disrupt the consensus splice site are a relatively common cause of aberrant splicing (PMID: 17576681, 9536098). Algorithms developed to predict the effect of sequence changes on RNA splicing suggest that this variant may disrupt the consensus splice site. 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. |
Eurofins Ntd Llc |
RCV000597411 | SCV000705775 | uncertain significance | not provided | 2017-01-19 | criteria provided, single submitter | clinical testing | |
Women's Health and Genetics/Laboratory Corporation of America, |
RCV001805154 | SCV002050731 | uncertain significance | not specified | 2021-12-01 | criteria provided, single submitter | clinical testing | Variant summary: GNE c.1374G>A (p.Lys458Lys) alters a conserved nucleotide located to the last nucleotide of exon 7, therefor it could affect mRNA splicing, leading to a significantly altered protein sequence. Several computational tools predict a significant impact on normal splicing: two predict the variant abolishes a 5' splicing donor site, and two predict the variant weakens a 5' donor site. However, these predictions have yet to be confirmed by functional studies. The variant was absent in 251416 control chromosomes (gnomAD). The available data on variant occurrences in the general population are insufficient to allow any conclusion about variant significance. To our knowledge, no occurrence of c.1374G>A in individuals affected with Inclusion Body Myopathy 2 and no experimental evidence demonstrating its impact on protein function have been reported. Two clinical diagnostic laboratories have submitted clinical-significance assessments for this variant to ClinVar after 2014, and both of them classified the variant as uncertain significance. Based on the evidence outlined above, the variant was classified as uncertain significance. |
Ambry Genetics | RCV002527742 | SCV003631944 | uncertain significance | Inborn genetic diseases | 2022-07-21 | criteria provided, single submitter | clinical testing | Occurs in the last base pair of the exon Based on insufficient or conflicting evidence, the clinical significance of this alteration remains unclear. |
Natera, |
RCV001829573 | SCV002075651 | uncertain significance | GNE myopathy | 2021-08-06 | no assertion criteria provided | clinical testing |