Total submissions: 7
Submitter | RCV | SCV | Clinical significance | Condition | Last evaluated | Review status | Method | Comment |
---|---|---|---|---|---|---|---|---|
Labcorp Genetics |
RCV000230943 | SCV000290804 | uncertain significance | Familial cancer of breast | 2022-10-24 | criteria provided, single submitter | clinical testing | This sequence change replaces tyrosine, which is neutral and polar, with cysteine, which is neutral and slightly polar, at codon 409 of the PALB2 protein (p.Tyr409Cys). This variant is present in population databases (no rsID available, gnomAD 0.003%). This variant has not been reported in the literature in individuals affected with PALB2-related conditions. ClinVar contains an entry for this variant (Variation ID: 241525). Advanced modeling of protein sequence and biophysical properties (such as structural, functional, and spatial information, amino acid conservation, physicochemical variation, residue mobility, and thermodynamic stability) performed at Invitae indicates that this missense variant is expected to disrupt PALB2 protein function. Experimental studies have shown that this missense change does not substantially affect PALB2 function (PMID: 31636395). In summary, the available evidence is currently insufficient to determine the role of this variant in disease. Therefore, it has been classified as a Variant of Uncertain Significance. |
Mendelics | RCV003492015 | SCV000839043 | likely benign | Hereditary cancer | 2024-01-23 | criteria provided, single submitter | clinical testing | |
Color Diagnostics, |
RCV000709387 | SCV000905272 | uncertain significance | Hereditary cancer-predisposing syndrome | 2023-11-21 | criteria provided, single submitter | clinical testing | This missense variant replaces tyrosine with cysteine at codon 409 of the PALB2 protein. Computational prediction is inconclusive regarding the impact of this variant on protein structure and function. A functional study has reported that the variant does not impact PALB2 function in a homology-directed repair assay (PMID: 31636395). This variant has been detected in a breast cancer case-control meta-analysis in 0/60466 cases and 1/53461 unaffected individuals (PMID: 33471991; Leiden Open Variation Database DB-ID PALB2_010708) and reported in an individual affected with breast cancer and an unaffected individual (PMID: 33811135). This variant has been identified in 1/250868 chromosomes in the general population by the Genome Aggregation Database (gnomAD). The available evidence is insufficient to determine the role of this variant in disease conclusively. Therefore, this variant is classified as a Variant of Uncertain Significance. |
Quest Diagnostics Nichols Institute San Juan Capistrano | RCV000985884 | SCV001134532 | uncertain significance | not provided | 2019-09-05 | criteria provided, single submitter | clinical testing | |
Laboratorio de Genetica e Diagnostico Molecular, |
RCV000230943 | SCV002512644 | uncertain significance | Familial cancer of breast | 2021-11-22 | criteria provided, single submitter | clinical testing | ACMG classification criteria: PM2 moderate |
Ambry Genetics | RCV000709387 | SCV002664832 | uncertain significance | Hereditary cancer-predisposing syndrome | 2023-01-26 | criteria provided, single submitter | clinical testing | The p.Y409C variant (also known as c.1226A>G), located in coding exon 4 of the PALB2 gene, results from an A to G substitution at nucleotide position 1226. The tyrosine at codon 409 is replaced by cysteine, an amino acid with highly dissimilar properties. This alteration was seen in 1/7840 breast cancer patients and 1/7928 controls in the South East Asian population (Ng PS et al. J Med Genet, 2022 May;59:481-491). This alteration was found to be functional in a homology-directed DNA repair (HDR) assay (Wiltshire T et al. Genet. Med., 2020 Mar;22:622-632). This amino acid position is highly conserved in available vertebrate species. In addition, the in silico prediction for this alteration is inconclusive. Since supporting evidence is limited at this time, the clinical significance of this alteration remains unclear. |
Baylor Genetics | RCV000230943 | SCV005053849 | uncertain significance | Familial cancer of breast | 2024-03-29 | criteria provided, single submitter | clinical testing |