Total submissions: 13
Submitter | RCV | SCV | Clinical significance | Condition | Last evaluated | Review status | Method | Comment |
---|---|---|---|---|---|---|---|---|
Ambry Genetics | RCV000129303 | SCV000184065 | pathogenic | Hereditary cancer-predisposing syndrome | 2022-01-13 | criteria provided, single submitter | clinical testing | The p.R554* pathogenic mutation (also known as c.1660C>T), located in coding exon 13 of the APC gene, results from a C to T substitution at nucleotide position 1660. This changes the amino acid from an arginine to a stop codon within coding exon 13. This mutation has been reported in multiple individuals diagnosed with familial adenomatous polyposis (FAP) or attenuated FAP (AFAP) (Fodde R et al. Genomics, 1992 Aug;13:1162-8; Ripa R et al. Eur J Hum Genet, 2002 Oct;10:631-7; Friedl W et al. Hered Cancer Clin Pract, 2005 Sep;3:95-114; Truta B et al. Fam Cancer, 2005;4:127-33; Filipe B et al. Clin Genet, 2009 Sep;76:242-55; Lagarde A et al. J Med Genet, 2010 Oct;47:721-2; Rivera B et al. Ann Oncol, 2011 Apr;22:903-909; de Oliveira JC et al. Cancer Med, 2019 05;8:2114-2122; Staninova-Stojovska M et al. Balkan J Med Genet, 2019 Dec;22:5-16). This variant is considered to be rare based on population cohorts in the Genome Aggregation Database (gnomAD). In addition to the clinical data presented in the literature, this alteration is expected to result in loss of function by premature protein truncation or nonsense-mediated mRNA decay. As such, this alteration is interpreted as a disease-causing mutation. |
University of Washington Department of Laboratory Medicine, |
RCV000210172 | SCV000266005 | pathogenic | Colorectal cancer, susceptibility to | 2015-11-20 | criteria provided, single submitter | clinical testing | |
Laboratory for Molecular Medicine, |
RCV000844608 | SCV000271308 | pathogenic | Familial multiple polyposis syndrome | 2021-06-28 | criteria provided, single submitter | clinical testing | The p.Arg554X variant in APC has been previously reported in at least 15 individuals with familial adenomatous polyposis (FAP) (Fodde 1992, Ripa 2002, Friedl 2005, Rivera 2011, Bisgaard 2004, Truta 2005) and was absent from large population studies. It has also been reported in ClinVar (Variation ID#807). This nonsense variant leads to a premature termination codon at position 554, which is predicted to lead to a truncated or absent protein. Heterozygous loss of function of the APC gene is an established disease mechanism in individuals with FAP. In summary, this variant meets criteria to be classified as pathogenic for familial adenomatous polyposis in an autosomal dominant manner. ACMG/AMP Criteria applied: PVS1, PS4, PM2_Supporting. |
Gene |
RCV000482405 | SCV000567480 | pathogenic | not provided | 2018-04-06 | criteria provided, single submitter | clinical testing | This variant is denoted APC c.1660C>T at the cDNA level and p.Arg554Ter (R554X) at the protein level. The substitution creates a nonsense variant, which changes an Arginine to a premature stop codon (CGA>TGA), and is predicted to cause loss of normal protein function through either protein truncation or nonsense-mediated mRNA decay. This variant has been reported in association with Familial Adenomatous Polyposis (FAP) (Fodde 1992, van der Luijt 1997, Blaker 2003, Friedl and Aretz 2005, Castellsague 2010) and is considered pathogenic. |
Labcorp Genetics |
RCV000000845 | SCV000647193 | pathogenic | Familial adenomatous polyposis 1 | 2024-01-21 | criteria provided, single submitter | clinical testing | This sequence change creates a premature translational stop signal (p.Arg554*) in the APC gene. It is expected to result in an absent or disrupted protein product. Loss-of-function variants in APC are known to be pathogenic (PMID: 17963004, 20685668). This variant is not present in population databases (gnomAD no frequency). This premature translational stop signal has been observed in individual(s) with familial adenomatous polyposis (PMID: 1324223, 12357334, 15108286, 15951963, 20223039, 20685668, 20924072). ClinVar contains an entry for this variant (Variation ID: 807). For these reasons, this variant has been classified as Pathogenic. |
Color Diagnostics, |
RCV000129303 | SCV000686849 | pathogenic | Hereditary cancer-predisposing syndrome | 2020-03-03 | criteria provided, single submitter | clinical testing | This variant changes 1 nucleotide in exon 14 of the APC gene, creating a premature translation stop signal. This variant is expected to result in an absent or non-functional protein product. To our knowledge, functional studies have not been reported for this variant. This variant has been reported in individuals affected with familial adenomatous polyposis (PMID: 1324223, 7524601, 10077047, 12357334, 15951963, 16680592, 19793053, 20223039, 20685668, 20924072, 21643010, 21779980, 26622826, 26845104). This variant has not been identified in the general population by the Genome Aggregation Database (gnomAD). Loss of APC function is a known mechanism of disease (clinicalgenome.org). Based on the available evidence, this variant is classified as Pathogenic. |
Fulgent Genetics, |
RCV000763541 | SCV000894354 | pathogenic | Desmoid disease, hereditary; Carcinoma of colon; Familial adenomatous polyposis 1; Neoplasm of stomach; Hepatocellular carcinoma | 2018-10-31 | criteria provided, single submitter | clinical testing | |
Genetics and Molecular Pathology, |
RCV000000845 | SCV002761773 | pathogenic | Familial adenomatous polyposis 1 | 2022-01-11 | criteria provided, single submitter | clinical testing | |
Myriad Genetics, |
RCV000000845 | SCV004043967 | pathogenic | Familial adenomatous polyposis 1 | 2023-05-02 | criteria provided, single submitter | clinical testing | This variant is considered pathogenic. This variant creates a termination codon and is predicted to result in premature protein truncation. |
KCCC/NGS Laboratory, |
RCV000000845 | SCV005387775 | pathogenic | Familial adenomatous polyposis 1 | 2024-11-03 | criteria provided, single submitter | clinical testing | This sequence change creates a premature translational stop signal (p.Arg554*) in the APC gene. It is expected to result in an absent or disrupted protein product. Loss-of function variants in APC are known to be pathogenic (PMID: 17963004, 20685668). This variant is not present in population databases (gnomAD no frequency). This premature translational stop signal has been observed in individual(s) with familial adenomatous polyposis (PMID: 1324223, 12357334, 15108286, 15951963, 20223039, 20685668, 20924072). ClinVar contains an entry for this variant (Variation ID: 807) classified as pathogenic by multiple submitters, no conflicts. For these reasons, this variant has been classified as Pathogenic |
OMIM | RCV000000845 | SCV000020995 | pathogenic | Familial adenomatous polyposis 1 | 1992-08-01 | no assertion criteria provided | literature only | |
Yale Center for Mendelian Genomics, |
RCV000000845 | SCV000784633 | pathogenic | Familial adenomatous polyposis 1 | 2015-11-27 | no assertion criteria provided | literature only | |
Laboratory for Genotyping Development, |
RCV003162203 | SCV002758123 | pathogenic | Gastric cancer | 2021-07-01 | no assertion criteria provided | research |