Total submissions: 4
Submitter | RCV | SCV | Clinical significance | Condition | Last evaluated | Review status | Method | Comment |
---|---|---|---|---|---|---|---|---|
Clin |
RCV000810454 | SCV001371770 | likely pathogenic | Glycogen storage disease, type II | 2024-10-29 | reviewed by expert panel | curation | The NM_000152.5:c.276C>A (p.Cys92Ter) variant in GAA is a nonsense variant predicted to cause a premature stop codon in biologically-relevant-exon 2 of 20, leading to nonsense mediated decay in a gene in which loss-of-function is an established disease mechanism (PVS1). This variant is absent in gnomAD v2.1.1. and v4.1.0. (PM2_Supporting). To our knowledge, this variant has not been reported in individuals with Pompe disease in the literature and functional studies are unavailable. There is a ClinVar entry for this variant (Variation ID: 654482). The classification of this variant has been upgraded from Variant of Uncertain Significance to likely pathogenic based on the recommendations of the ClinGen Sequence Variant Interpretation Working Group, that a variant meeting PVS1 and PM2_Supporting is classified as Likely Pathogenic (https://clinicalgenome.org/site/assets/files/5182/pm2_-_svi_recommendation_-_approved_sept2020.pdf ). In summary, this variant meets the criteria to be classified as likely pathogenic for Pompe disease. GAA-specific ACMG/AMP criteria applied, as specified by the ClinGen Lysosomal Diseases Variant Curation Expert Panel (Specifications Version 2.0): PVS1, PM2_Supporting. (Classification approved by the ClinGen Lysosomal Diseases Variant Curation Expert Panel on October 29, 2024). |
Labcorp Genetics |
RCV000810454 | SCV000950653 | pathogenic | Glycogen storage disease, type II | 2023-05-28 | criteria provided, single submitter | clinical testing | This variant is not present in population databases (gnomAD no frequency). ClinVar contains an entry for this variant (Variation ID: 654482). This variant has not been reported in the literature in individuals affected with GAA-related conditions. This sequence change creates a premature translational stop signal (p.Cys92*) in the GAA gene. It is expected to result in an absent or disrupted protein product. Loss-of-function variants in GAA are known to be pathogenic (PMID: 18425781, 22252923). For these reasons, this variant has been classified as Pathogenic. |
Fulgent Genetics, |
RCV000810454 | SCV002810305 | likely pathogenic | Glycogen storage disease, type II | 2024-03-26 | criteria provided, single submitter | clinical testing | |
Baylor Genetics | RCV000810454 | SCV004197847 | likely pathogenic | Glycogen storage disease, type II | 2023-04-04 | criteria provided, single submitter | clinical testing |