rs199476118

Variant summary

Our verdict is Pathogenic. The variant received 10 ACMG points: 10P and 0B. PS4PM6_SupportingPP1_ModeratePP3PS3_Moderate

This summary comes from the ClinGen Evidence Repository: The m.3460G>A (p.A52T) variant in MT-ND1 has been reported in affected individuals from more than 50 kindreds (PS4, PMIDs: 1928099, 1674640, 7629530, 1734726, 1550131, 8496715, 8024249, 8556281, 8571959, 12205655, 11906302, 12807863, 12518276, 16738010, 17122117, 18216301, 18562849, 20232220, 21887510, 25338955, 25053773, 28314831, 30053855, 30591017). While this variant is one of the three most common variants associated with Leber Hereditary Optic Neuropathy (LHON; PMID:20301353), affected individuals can also have other features. Indeed, several individuals have been reported with multiple sclerosis. Other features have been variably seen in affected individuals including sensorineural hearing loss, auditory neuropathy, epilepsy, migraines, Parkinsonism, dystonia, Leigh syndrome, spinal cord lesions, myoclonus, myopathy, hypertension, high triglycerides, diabetes, and cardiac involvement. Testing excluding separate etiologies for these features has been limited. Heteroplasmy levels in affected individuals ranged from 58% to homoplasmy. Age of onset varied from four years old to 75 years old. This variant segregated with disease in multiple affected members in multiple families and several healthy family members had lower to undetectable levels of the variant (PP1_moderate; PMIDs: 1734726, 8571959, 11906302). There is one reported de novo occurrence to our knowledge (PM6_supporting; PMID:12518276). This variant is present in the healthy population, which is to be expected given the known reduced penetrance of this variant. The computational predictor APOGEE gives a consensus rating of pathogenic with a score of 0.86 (Min=0, Max=1), which predicts a damaging effect on gene function (PP3). Extensive cybrid studies supported the functional impact of this variant, as do E. coli and mouse studies (PS3_moderate PMIDs: 35383288, 22079202, 15720387, 15883259, 15342361, 10976107). In summary, this variant meets criteria to be classified as pathogenic for primary mitochondrial disease inherited in a mitochondrial manner. This classification was approved by the NICHD/NINDS U24 ClinGen Mitochondrial Disease Variant Curation Expert Panel on April 25, 2023. Mitochondrial DNA-specific ACMG/AMP criteria applied (PMID:32906214): PS4, PP1_moderate, PM6_supporting, PP3, PS3_moderate. LINK:https://erepo.genome.network/evrepo/ui/classification/CV9722/MONDO:0044970/014

Frequency

Mitomap GenBank:
Absent

Consequence

MT-ND1
ENST00000361390.2 missense

Scores

Apogee2
Pathogenic
0.87

Clinical Significance

Pathogenic reviewed by expert panel P:11O:2
LHON

Conservation

PhyloP100: 6.38

Publications

243 publications found
Variant links:
Genes affected
MT-ND1 (HGNC:7455): (mitochondrially encoded NADH dehydrogenase 1) Enables NADH dehydrogenase (ubiquinone) activity. Involved in mitochondrial electron transport, NADH to ubiquinone and mitochondrial respiratory chain complex I assembly. Located in mitochondrial membrane. Part of mitochondrial respiratory chain complex I. Implicated in several diseases, including MELAS syndrome; neurodegenerative disease (multiple); optic nerve disease (multiple); toxic shock syndrome; and type 2 diabetes mellitus. Biomarker of Alzheimer's disease; Parkinson's disease; and multiple sclerosis. [provided by Alliance of Genome Resources, Apr 2022]
TRNL1 (HGNC:7490): (mitochondrially encoded tRNA leucine 1 (UUA/G)) Implicated in cardiomyopathy. [provided by Alliance of Genome Resources, Apr 2022]
MT-RNR2 (HGNC:7471): (mitochondrially encoded 16S RNA) Enables G protein-coupled receptor binding activity; protein self-association; and receptor antagonist activity. Involved in several processes, including leukocyte chemotaxis; negative regulation of cell death; and negative regulation of neuroinflammatory response. Located in several cellular components, including mitochondrion; perinuclear region of cytoplasm; and sperm midpiece. [provided by Alliance of Genome Resources, Apr 2022]
MT-RNR2 Gene-Disease associations (from GenCC):
  • mitochondrial disease
    Inheritance: Mitochondrial Classification: LIMITED Submitted by: ClinGen

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ACMG classification

Classification was made for transcript

Our verdict: Pathogenic. The variant received 10 ACMG points.

PS3
For more information check the summary or visit ClinGen Evidence Repository.
PS4
For more information check the summary or visit ClinGen Evidence Repository.
PM6
For more information check the summary or visit ClinGen Evidence Repository.
PP1
For more information check the summary or visit ClinGen Evidence Repository.
PP3
For more information check the summary or visit ClinGen Evidence Repository.

Transcripts

RefSeq

Gene Transcript HGVSc HGVSp Effect Exon rank MANE Protein UniProt
ND1unassigned_transcript_4789 c.154G>A p.Ala52Thr missense_variant Exon 1 of 1
TRNL1unassigned_transcript_4788 c.*156G>A downstream_gene_variant
RNR2unassigned_transcript_4787 n.*231G>A downstream_gene_variant

Ensembl

Gene Transcript HGVSc HGVSp Effect Exon rank TSL MANE Protein Appris UniProt
MT-ND1ENST00000361390.2 linkc.154G>A p.Ala52Thr missense_variant Exon 1 of 1 6 ENSP00000354687.2
MT-TL1ENST00000386347.1 linkn.*156G>A downstream_gene_variant 6
MT-RNR2ENST00000387347.2 linkn.*231G>A downstream_gene_variant 6

Frequencies

Mitomap GenBank
The variant is not present, suggesting it is rare.
Gnomad homoplasmic
AF:
0.0
AC:
0
AN:
56426
Gnomad heteroplasmic
AF:
0.000018
AC:
1
AN:
56426

Mitomap

Disease(s): LHON
Status: Cfrm-[P]
Publication(s): 1674640

ClinVar

Significance: Pathogenic
Submissions summary: Pathogenic:11Other:2
Revision: reviewed by expert panel
LINK: link

Submissions by phenotype

Leber optic atrophy Pathogenic:4Other:1
GeneReviews
Significance:not provided
Review Status:no classification provided
Collection Method:literature only

This variant is one of the three most common causes of LHON.

May 04, 2022
Mendelics
Significance:Pathogenic
Review Status:criteria provided, single submitter
Collection Method:clinical testing

Oct 17, 2019
Wong Mito Lab, Molecular and Human Genetics, Baylor College of Medicine
Significance:Pathogenic
Review Status:criteria provided, single submitter
Collection Method:clinical testing

The NC_012920.1:m.3460G>A (YP_003024026.1:p.Ala52Thr) variant in MTND1 gene is interpretated to be a Pathogenic variant based on the modified ACMG guidelines (unpublished). This variant meets the following evidence codes: PS1, PS3

Jul 10, 2007
OMIM
Significance:Pathogenic
Review Status:no assertion criteria provided
Collection Method:literature only

Genomics England Pilot Project, Genomics England
Significance:Pathogenic
Review Status:no assertion criteria provided
Collection Method:clinical testing

not provided Pathogenic:3
Oct 23, 2020
Institute of Medical Genetics and Applied Genomics, University Hospital Tübingen
Significance:Pathogenic
Review Status:criteria provided, single submitter
Collection Method:clinical testing

Nov 22, 2017
ARUP Laboratories, Molecular Genetics and Genomics, ARUP Laboratories
Significance:Pathogenic
Review Status:criteria provided, single submitter
Collection Method:clinical testing

m.3460G>A is one of a small number of primary variants which are causative of Leber hereditary optic neuropathy (LHON; MIM: 535000; Howell 1992). It is estimated that 15%-25% of LHON families carry the g.3460G>A variant (Howell 1991).

Oct 04, 2022
Clinical Genetics Laboratory, Skane University Hospital Lund
Significance:Pathogenic
Review Status:criteria provided, single submitter
Collection Method:clinical testing

Leber optic atrophy and dystonia Pathogenic:1
Feb 05, 2025
3billion
Significance:Pathogenic
Review Status:criteria provided, single submitter
Collection Method:clinical testing

The variant is observed at an extremely low frequency in the gnomAD v4.1.0 dataset (heteroplasmic allele frequency: 0.002%). Predicted Consequence/Location: Mitochondrial variant Functional studies provide moderate evidence of the variant having a damaging effect on the gene or gene product (PMID: 1959619). The same nucleotide change resulting in the same amino acid change has been previously reported as pathogenic/likely pathogenic with strong evidence (3billion dataset/ClinVar ID: VCV000009722). A different missense change at the same codon (p.Ala52Val) has been reported as pathogenic/likely pathogenic with strong evidence (Mitomap PMID: 32355048). Therefore, this variant is classified as Pathogenic according to the recommendation of ACMG/AMP guideline.

Mitochondrial disease Pathogenic:1
Apr 25, 2023
ClinGen Mitochondrial Disease Nuclear and Mitochondrial Variant Curation Expert Panel, ClinGen
Significance:Pathogenic
Review Status:reviewed by expert panel
Collection Method:curation

The m.3460G>A (p.A52T) variant in MT-ND1 has been reported in affected individuals from more than 50 kindreds (PS4, PMIDs: 1928099, 1674640, 7629530, 1734726, 1550131, 8496715, 8024249, 8556281, 8571959, 12205655, 11906302, 12807863, 12518276, 16738010, 17122117, 18216301, 18562849, 20232220, 21887510, 25338955, 25053773, 28314831, 30053855, 30591017). While this variant is one of the three most common variants associated with Leber Hereditary Optic Neuropathy (LHON; PMID: 20301353), affected individuals can also have other features. Indeed, several individuals have been reported with multiple sclerosis. Other features have been variably seen in affected individuals including sensorineural hearing loss, auditory neuropathy, epilepsy, migraines, Parkinsonism, dystonia, Leigh syndrome, spinal cord lesions, myoclonus, myopathy, hypertension, high triglycerides, diabetes, and cardiac involvement. Testing excluding separate etiologies for these features has been limited. Heteroplasmy levels in affected individuals ranged from 58% to homoplasmy. Age of onset varied from four years old to 75 years old. This variant segregated with disease in multiple affected members in multiple families and several healthy family members had lower to undetectable levels of the variant (PP1_moderate; PMIDs: 1734726, 8571959, 11906302). There is one reported de novo occurrence to our knowledge (PM6_supporting; PMID: 12518276). This variant is present in the healthy population, which is to be expected given the known reduced penetrance of this variant. The computational predictor APOGEE gives a consensus rating of pathogenic with a score of 0.86 (Min=0, Max=1), which predicts a damaging effect on gene function (PP3). Extensive cybrid studies supported the functional impact of this variant, as do E. coli and mouse studies (PS3_moderate PMIDs: 35383288, 22079202, 15720387, 15883259, 15342361, 10976107). In summary, this variant meets criteria to be classified as pathogenic for primary mitochondrial disease inherited in a mitochondrial manner. This classification was approved by the NICHD/NINDS U24 ClinGen Mitochondrial Disease Variant Curation Expert Panel on April 25, 2023. Mitochondrial DNA-specific ACMG/AMP criteria applied (PMID: 32906214): PS4, PP1_moderate, PM6_supporting, PP3, PS3_moderate.

Optic atrophy Pathogenic:1
Jan 01, 2018
Institute of Human Genetics, Univ. Regensburg, Univ. Regensburg
Significance:Pathogenic
Review Status:no assertion criteria provided
Collection Method:clinical testing

MITOCHONDRIAL COMPLEX I DEFICIENCY, MITOCHONDRIAL TYPE 3 Pathogenic:1
Jul 10, 2007
OMIM
Significance:Pathogenic
Review Status:no assertion criteria provided
Collection Method:literature only

Leigh syndrome Other:1
GeneReviews
Significance:not provided
Review Status:no classification provided
Collection Method:literature only

Computational scores

Source: dbNSFP v4.3

Name
Calibrated prediction
Score
Prediction
Apogee2
Pathogenic
0.87
Hmtvar
Pathogenic
0.76
AlphaMissense
Pathogenic
0.62
BayesDel_addAF
Uncertain
0.13
D
DEOGEN2
Benign
0.13
T
LIST_S2
Benign
0.80
T
MutationAssessor
Uncertain
2.8
M
PhyloP100
6.4
PROVEAN
Uncertain
-2.4
N
Sift4G
Pathogenic
0.0010
D
GERP RS
4.8
Varity_R
0.63
Mutation Taster
=71/29
polymorphism

Publications

Other links and lift over

dbSNP: rs199476118; hg19: chrM-3461; COSMIC: COSV62293268; COSMIC: COSV62293268; API