Total submissions: 7
Submitter | RCV | SCV | Clinical significance | Condition | Last evaluated | Review status | Method | Comment |
---|---|---|---|---|---|---|---|---|
Soonchunhyang University Bucheon Hospital, |
RCV000032022 | SCV000267236 | uncertain significance | Biotinidase deficiency | 2016-03-18 | criteria provided, single submitter | reference population | |
Gene |
RCV000520641 | SCV000617652 | uncertain significance | not provided | 2020-06-17 | criteria provided, single submitter | clinical testing | Not observed at a significant frequency in large population cohorts (Lek et al., 2016); In silico analysis supports that this missense variant has a deleterious effect on protein structure/function; This variant is associated with the following publications: (PMID: 26361991, 15776412) |
Labcorp Genetics |
RCV000032022 | SCV000834107 | pathogenic | Biotinidase deficiency | 2024-04-25 | criteria provided, single submitter | clinical testing | This sequence change replaces asparagine, which is neutral and polar, with serine, which is neutral and polar, at codon 214 of the BTD protein (p.Asn214Ser). This variant is present in population databases (rs397514377, gnomAD 0.009%). This missense change has been observed in individuals with biotinidase deficiency (PMID: 15776412, 25144890, 29995633; Invitae). ClinVar contains an entry for this variant (Variation ID: 38579). 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 BTD protein function with a positive predictive value of 95%. This variant disrupts the p.Asn214 amino acid residue in BTD. Other variant(s) that disrupt this residue have been observed in individuals with BTD-related conditions (PMID: 26361991), which suggests that this may be a clinically significant amino acid residue. For these reasons, this variant has been classified as Pathogenic. |
Baylor Genetics | RCV000032022 | SCV004211423 | likely pathogenic | Biotinidase deficiency | 2023-11-28 | criteria provided, single submitter | clinical testing | |
Breakthrough Genomics, |
RCV000520641 | SCV005187548 | uncertain significance | not provided | criteria provided, single submitter | not provided | ||
Quest Diagnostics Nichols Institute San Juan Capistrano | RCV000520641 | SCV005625381 | likely pathogenic | not provided | 2024-11-22 | criteria provided, single submitter | clinical testing | The BTD c.641A>G (p.Asn214Ser) variant has been reported in the published literature in either a homozygous state or with another pathogenic variant associated with biotinidase deficiency in multiple individuals affected with partial biotinidase deficiency (10-30% of normal BTD activity) (PMID: 25144890 (2015), 26361991 (2015), 29995633 (2018), 33217065 (2021), 35195902 (2022), 38299772 (2024)). This variant has also been reported in a heterozygous state in an individual with approximately 60% of normal BTD enzyme activity (PMID: 38299772 (2024)). The frequency of this variant in the general population, 0.0001 (13/129166 chromosomes (Genome Aggregation Database, http://gnomad.broadinstitute.org)), is uninformative in the assessment of its pathogenicity. Analysis of this variant using bioinformatics tools for the prediction of the effect of amino acid changes on protein structure and function yielded predictions that this variant is damaging. Based on the available information, this variant is classified as likely pathogenic. |
Fulgent Genetics, |
RCV000032022 | SCV005660279 | likely pathogenic | Biotinidase deficiency | 2024-03-08 | criteria provided, single submitter | clinical testing |