Total submissions: 3
Submitter | RCV | SCV | Clinical significance | Condition | Last evaluated | Review status | Method | Comment |
---|---|---|---|---|---|---|---|---|
Clin |
RCV000993611 | SCV001146719 | pathogenic | Phenylketonuria | 2019-07-07 | reviewed by expert panel | curation | The PAH:p.M1L variant is a predicted start-lost variant in the canonical transcript of PAH (ENST00000553106); There are no other PAH RefSeq transcripts. The next in-frame Met is at amino acid 180 in exon 6. There are 49 pathogenic variants in ClinVar upstream of aa 180. The p.Met1Val variant has <3% enzyme activity as compared to wild type (PMID: 9450897), confirming start loss variants lead to loss of function of the PAH enzyme without re-initiation. This variant was reported in trans with the pathogenic variant p.Arg241His (PM3) in 1 Mexican proband with mild PKU (PMID: 24941924; PP4). It is absent from control databases (PM2). In summary, this variant meets criteria to be classified as pathogenic for PAH. PAH-specific ACMG/AMP criteria applied: PP4, PM2, PM3, PVS1. |
Labcorp Genetics |
RCV000993611 | SCV004296196 | pathogenic | Phenylketonuria | 2023-08-29 | criteria provided, single submitter | clinical testing | For these reasons, this variant has been classified as Pathogenic. Experimental studies have shown that disruption of the initiator codon affects PAH function (PMID: 1301201). Algorithms developed to predict the effect of variants on protein structure and function are not available or were not evaluated for this variant. ClinVar contains an entry for this variant (Variation ID: 102626). Disruption of the initiator codon has been observed in individual(s) with clinical features of PAH-related conditions (PMID: 2574002, 26666653; Invitae). This variant is not present in population databases (gnomAD no frequency). This sequence change affects the initiator methionine of the PAH mRNA. The next in-frame methionine is located at codon 180. |
De |
RCV000088869 | SCV000119465 | not provided | not provided | no assertion provided | not provided |