Total submissions: 4
Submitter | RCV | SCV | Clinical significance | Condition | Last evaluated | Review status | Method | Comment |
---|---|---|---|---|---|---|---|---|
Counsyl | RCV000670278 | SCV000795112 | likely pathogenic | Neuronal ceroid lipofuscinosis 3 | 2017-10-27 | criteria provided, single submitter | clinical testing | |
Illumina Laboratory Services, |
RCV000778462 | SCV000914714 | uncertain significance | Neuronal ceroid lipofuscinosis | 2018-11-07 | criteria provided, single submitter | clinical testing | The CLN3 c.47-1G>A variant occurs in a canonical splice site (acceptor) and is therefore predicted to disrupt or distort the normal gene product. A literature search was performed for the gene and cDNA change. No publications were found based on this search. This variant is not found in the 1000 Genomes Project, Exome Sequencing Project, Exome Aggregation Consortium, or Genome Aggregation Database in a region of good sequencing coverage. It is therefore presumed to be rare. Based on the potential impact of splice acceptor variants and the lack of clarifying evidence, the c.47-1G>A variant is classified as a variant of unknown significance but suspicious for pathogenicity for neuronal ceroid-lipofuscinosis. This variant was observed by ICSL as part of a predisposition screen in an ostensibly healthy population. |
Invitae | RCV000778462 | SCV001404997 | likely pathogenic | Neuronal ceroid lipofuscinosis | 2023-11-28 | criteria provided, single submitter | clinical testing | This sequence change affects an acceptor splice site in intron 2 of the CLN3 gene. It is expected to disrupt RNA splicing. Variants that disrupt the donor or acceptor splice site typically lead to a loss of protein function (PMID: 16199547), and loss-of-function variants in CLN3 are known to be pathogenic (PMID: 9311735, 28542676). This variant is not present in population databases (gnomAD no frequency). This variant has not been reported in the literature in individuals affected with CLN3-related conditions. ClinVar contains an entry for this variant (Variation ID: 554608). 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 currently available evidence indicates that the variant is pathogenic, but additional data are needed to prove that conclusively. Therefore, this variant has been classified as Likely Pathogenic. |
Baylor Genetics | RCV000670278 | SCV004214321 | likely pathogenic | Neuronal ceroid lipofuscinosis 3 | 2024-01-05 | criteria provided, single submitter | clinical testing |