Total submissions: 4
Submitter | RCV | SCV | Clinical significance | Condition | Last evaluated | Review status | Method | Comment |
---|---|---|---|---|---|---|---|---|
Clin |
RCV000886768 | SCV005089703 | uncertain significance | Glycogen storage disease, type II | 2024-04-02 | reviewed by expert panel | curation | The NM_000152.5:c.1346C>T variant in GAA is a missense variant predicted to cause substitution of serine with leucine at amino acid 449 (p.Ser449Leu). The highest population minor allele frequency in gnomAD v2.1.1. is 0.001177 (36/30594 alleles), including 2 homozygotes, in the South Asian population, which is lower than the ClinGen Lysosomal Diseases VCEP’s threshold for PM2_Supporting (<0.001), meeting this criterion. Three patient(s) with this variant had documented GAA deficiency with activity in the affected range in muscle, cultured skin fibroblasts, leukocytes, lymphocytes, whole blood or dried blood spot (PMIDs 33202836, 33301762). However, due to the frequency of homozygotes in gnomAD, PP4 was not applied. The computational predictor REVEL gives a score of 0.307 which is below the threshold of 0.5, evidence that does not predict a damaging effect on GAA function (BP4). There is a ClinVar entry for this variant (Variation ID: 714463, 1-star review status) with one submitter classifying as likely benign and one classifying as a variant of uncertain significance. In summary, this variant meets the criteria to be classified as a variant of uncertain significance for Pompe disease based on the ACMG/AMP criteria applied, as specified by the ClinGen Lysosomal Diseases Variant Curation Expert Panel (specifications Version 2.0): PM2_Supporting, BP4. (Classification approved by the ClinGen Lysosomal Diseases Variant Curation Expert Panel on April 2, 2024). |
Labcorp Genetics |
RCV000886768 | SCV001030295 | likely benign | Glycogen storage disease, type II | 2025-01-23 | criteria provided, single submitter | clinical testing | |
Revvity Omics, |
RCV003130083 | SCV003810585 | uncertain significance | not provided | 2023-08-16 | criteria provided, single submitter | clinical testing | |
Mayo Clinic Laboratories, |
RCV003130083 | SCV005408537 | uncertain significance | not provided | 2024-05-31 | criteria provided, single submitter | clinical testing |