Total submissions: 4
Submitter | RCV | SCV | Clinical significance | Condition | Last evaluated | Review status | Method | Comment |
---|---|---|---|---|---|---|---|---|
CFTR- |
RCV001009517 | SCV001169612 | pathogenic | Cystic fibrosis; CFTR-related disorder | 2018-01-29 | criteria provided, single submitter | curation | the variant causes a phenotype but regarding our data, we can't formally attribute it to CF, CFTR-RD or both |
Institute of Human Genetics, |
RCV002284359 | SCV002574063 | pathogenic | Cystic fibrosis | 2022-09-05 | criteria provided, single submitter | curation | This variant was identified in 2 unrelated patients with a clinically confirmed diagnosis of cystic fibrosis. The variant was classified in the context of a project re-classifying variants in the German Cystic Fibrosis Registry (Muko.e.V.). Link: https://www.muko.info/angebote/qualitaetsmanagement/register/cf-einrichtungen/mukoweb. Criteria applied: PVS1, PM2_SUP, PM3, PP4 |
Ambry Genetics | RCV002284359 | SCV002704174 | pathogenic | Cystic fibrosis | 2021-10-08 | criteria provided, single submitter | clinical testing | The c.165-2A>G intronic pathogenic mutation, also known as 297-2A>G, results from an A to G substitution two nucleotides before coding exon 3 in the CFTR gene. This variant (reported as 297-2A>G) was detected in two siblings with clinical presentations of cystic fibrosis: a male with meconium ileus and lung disease who died at the age of 3 months, and a female with a positive sweat chloride test, pancreatic insufficiency, severe lung disease and P. aeruginosa colonization before 3 years of age. The mutation was heterozygous and found to be in trans with c.2463_2464del (p.S821fs, also known as 2594delGT) on the other chromosome (Visich A et al. Clin. Genet., 2002 Mar;61:207-13). This variant is considered to be rare based on population cohorts in the Genome Aggregation Database (gnomAD). In silico splice site analysis predicts that this alteration will weaken the native splice acceptor site. In addition to the clinical data presented in the literature, alterations that disrupt the canonical splice site are expected to cause aberrant splicing, resulting in an abnormal protein or a transcript that is subject to nonsense-mediated mRNA decay. As such, this alteration is classified as a disease-causing mutation. |
Labcorp Genetics |
RCV002284359 | SCV004684914 | pathogenic | Cystic fibrosis | 2022-12-22 | criteria provided, single submitter | clinical testing | For these reasons, this variant has been classified as Pathogenic. Algorithms developed to predict the effect of sequence changes on RNA splicing suggest that this variant may disrupt the consensus splice site. ClinVar contains an entry for this variant (Variation ID: 53315). This variant is also known as 297-2A>G. Disruption of this splice site has been observed in individuals with cystic fibrosis (PMID: 10798368, 12000363, 16980811). This variant is not present in population databases (gnomAD no frequency). This sequence change affects an acceptor splice site in intron 2 of the CFTR 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 CFTR are known to be pathogenic (PMID: 1695717, 7691345, 9725922). |