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Variant interpretation report

IDH1 c.394C>A, p.Arg132Ser

NM_005896.4:c.394C>A NP_005887.2:p.(Arg132Ser) Missense · exon 4 View identifiers
Classification
Likely pathogenic

Variant description:

The IDH1 NM_005896.4:c.394C>A (NP_005887.2:p.(Arg132Ser)) missense variant has previously been reported in somatic cancers (COSMIC; COSV61615649, n = 217 times), and lies in a statistically significant hotspot (cancerhotspots.org). Experimental evidence: Recombinant IDH1 R132S showed gain-of-function NADPH-dependent alpha-ketoglutarate reduction to 2-hydroxyglutarate in a variant-specific enzyme assay. Based on available guidelines, this variant is considered to be Likely Pathogenic.

Five-step scale from benign to pathogenic. This variant is likely pathogenic. Select a step to read what it means.

Likely pathogenic.A likely pathogenic classification under the recorded framework.

In plain language

Gene-level background from the recorded interpretation.

About IDH1

IDH1 encodes a cytoplasmic and peroxisomal enzyme that converts isocitrate to alpha-ketoglutarate and helps produce NADPH, supporting cellular metabolism and antioxidant processes. Altered IDH1 activity is associated with several cancers, including glioma, cholangiocarcinoma, and acute myeloid leukemia. In cancer, abnormal IDH1 activity can produce D-2-hydroxyglutarate, which disrupts cellular enzymes that regulate DNA and histone modification and can promote tumor development.

LYFE Sciences is an AI system, and it can make mistakes. Criteria may be applied incorrectly, sources may be misread, and a confident-looking classification can still be wrong. Double-check every criterion and its underlying evidence before relying on any call.
01The reasoning

How it was classified

The recorded framework is Generic ACMG/AMP 2015 with ClinGen SVI recommendations. The criteria and strengths shown below come from the saved assessment; this page does not recalculate the classification.

Recorded applied criteria

The applied criteria and their strengths are shown as assessed under the stated framework.

Pathogenic evidence criteria: 4 Benign evidence criteria: 0
Pathogenic criteria applied · 4
PS3Supporting
PS3 · supporting

Met at supporting: recombinant IDH1 R132S showed gain-of-function NADPH-dependent alpha-ketoglutarate reduction to 2-hydroxyglutarate in a variant-specific enzyme assay.

PM1Moderate
PM1 · moderate

Met: Arg132 is an IDH1 active-site hotspot, and the variant lies in a statistically significant hotspot with gnomAD allele count 0.

PM2Supporting
PM2 · supporting

Met at supporting strength: gnomAD v4.1 observed 0/1,613,196 alleles (AF 0), below the PM2 threshold of 0.0001.

PP3Moderate
PP3 · moderate

Met at moderate strength: missense REVEL score 0.904 exceeds the PP3 moderate threshold of 0.773.

Benign criteria applied · 0

No benign criterion marked as applied in the recorded assessment.

Recorded classification: Likely pathogenic

Likely Pathogenic: PS3 and PM2 supporting plus PM1 and PP3 moderate satisfy the generic ACMG/AMP rule for 2 moderate and 2 supporting criteria.

02The sources

Evidence at a glance

Evidence summaries and captured source records, where available. Missing entries should not be interpreted as negative findings.

No screenshot for this evidence
REVEL score
0.904 recorded score

Recorded REVEL score: 0.904. Refer to the recorded PP3/BP4 rationale for interpretation.

ClinVar submissions
1 reported laboratory submissions

1 Pathogenic. ClinVar API review status: criteria provided, single submitter.

Context only ClinVar ↗
Functional evidence
Statement recorded

OncoKB identified variant-specific curated literature and context relevant to functional review; curated oncogenicity label: Likely Oncogenic.

COSMIC
Cancer Hotspots
Somatic evidence
217 recorded samples

This variant has previously been reported in somatic cancers (COSMIC; COSV61615649, n = 217 times).

Cancer Hotspots

This variant lies in a statistically significant hotspot.

For specialists

Technical detail

ACMG/AMP criteria under Generic ACMG/AMP 2015 with ClinGen SVI recommendations, with the data and sources behind each one.

28 criteria with recorded statuses: 4 met · 8 not met · 12 not assessed · 4 not applicable. Open any row for the full reasoning, the rule and the evidence behind it.

Met Not met Not assessed Not applicable

Only the requested codon/residue/domain criteria were assessed.

PM1 is met from the Arg132 active-site hotspot evidence and absence of the variant in gnomAD; PS1 is not met, PM5 is not assessed because a validated pathogenic comparator is lacking, and PP2/BP1 are not assessed because their required gene-level mechanisms are not established in the supplied evidence.

None of PS2, PM6, PP1, or BS4 can be assessed because the available evidence contains no germline proband-parent testing, pedigree, informative meioses, familial segregation, or affected-relative non-segregation data.

The exact IDH1 p.Arg132Ser variant has direct variant-specific biochemical evidence of altered, disease-relevant enzyme activity supporting PS3 at supporting strength; the same result does not support BS3.

No VCEP covers IDH1 in this case; generic ACMG/AMP 2015 definitions govern.

The available literature establishes occurrence of IDH1 p.Arg132Ser in affected cohorts but does not provide the matched controls needed for PS4.

ClinVar's exact-variant Pathogenic assertion is a single-submitter clinical-laboratory result, not an expert-panel classification, so it does not trigger PP5 or BP6.

The variant is missense, so PP3 and BP4 use the mutually exclusive REVEL path and do not use SpliceAI.

REVEL 0.904 supports PP3 at moderate strength and does not support BP4.

Met · 4

PS3 SupportingACMG_2015Met at supporting: recombinant IDH1 R132S showed gain-of-function NADPH-dependent alpha-ketoglutarate reduction to 2-hydroxyglutarate in a variant-specific enzyme assay. Details ▾Hide ▴
Reasoning

PS3 is met at supporting strength. Dang et al. directly tested the exact IDH1 p.Arg132Ser variant (NM_005896.4:c.394C>A) using recombinant, site-directed-mutagenesis-derived protein expressed and purified from E. coli. In enzymatic assays, R132S produced a gain of function for NADPH-dependent reduction of alpha-ketoglutarate to 2-hydroxyglutarate, the disease-relevant altered biochemical activity. This is direct variant-specific functional evidence with an appropriate wild-type comparison and biologically relevant enzyme readout. The evidence is not calibrated above supporting because the bundle documents one research assay study rather than reproducible validation in a clinical diagnostic laboratory setting or multiple independently replicated assays.

Rule
Well-established in vitro or in vivo functional studies supportive of a damaging effect on the gene or gene product.
Evidence considered
  • Dang et al. 2009, Cancer-associated IDH1 mutations produce 2-hydroxyglutarate: the exact IDH1 R132S mutant was generated by site-directed mutagenesis, expressed and purified from E. coli, and tested in enzymatic assays; the paper states, "Similar to R132H mutant protein, R132C, R132L, and R132S mutations all result in a gain-of-function for NADPH-dependent reduction of alphaKG (Supplementary Figure 4)."
  • The assay measured the biologically relevant IDH1 reaction, NADPH-dependent reduction of alpha-ketoglutarate to 2-hydroxyglutarate, and directly included the reported p.Arg132Ser substitution.
Still missing
  • No documented independent replication or clinical diagnostic laboratory validation was identified for this exact variant-specific assay.
Sources
PM1 ModerateACMG_2015Met: Arg132 is an IDH1 active-site hotspot, and the variant lies in a statistically significant hotspot with gnomAD allele count 0. Details ▾Hide ▴
Reasoning

IDH1 p.Arg132Ser lies at Arg132, a recurrent IDH1 mutational hotspot and active-site residue. The Cancer Hotspots result states that the variant lies in a statistically significant hotspot, and PMID:19935646 describes cancer-associated IDH1 mutations occurring at a single amino-acid residue of the active site. The variant is absent from gnomAD v2.1 and gnomAD v4.1; no benign population observation was identified for this variant. No VCEP domain table applies because IDH1 has no governing VCEP in this case.

Rule
Located in a mutational hot spot and/or critical and well-established functional domain (e.g. active site of an enzyme) without benign variation.
Evidence considered
  • Cancer Hotspots result for IDH1 R132: the variant lies in a statistically significant hotspot.
  • PMID:19935646 states that cancer-associated IDH1 mutations occur at a single amino-acid residue of the IDH1 active site.
  • gnomAD v2.1: absent.
  • gnomAD v4.1: 0/1,613,196 alleles, 0 homozygotes.
Sources
PM2 SupportingACMGMet at supporting strength: gnomAD v4.1 observed 0/1,613,196 alleles (AF 0), below the PM2 threshold of 0.0001. Details ▾Hide ▴
Reasoning

PM2 is met at supporting strength. The variant is absent from gnomAD v2.1 and is observed 0 times among 1,613,196 all-comers gnomAD v4.1 alleles, with 0 homozygotes; the resulting AF of 0 is at or below the supplied generic PM2 supporting threshold of 0.0001. No governing VCEP specifies a non-cancer or exome-only source, so the default all-comers datasets apply.

Rule
Absent from controls (or at extremely low frequency if recessive) in Exome Sequencing Project, 1000 Genomes or Exome Aggregation Consortium. ... PM2 (supporting): <= 0.0001 — SVI recommendation to downgrade PM2 to Supporting (ClinGen SVI 2020)
Evidence considered
  • gnomAD v2.1 reports the variant as absent.
  • gnomAD v4.1 all-comers data report total AC=0, AN=1,613,196, AF=0, and homozygotes=0.
  • No VCEP covers IDH1 in this case; therefore the default all-comers gnomAD sources apply rather than a non-cancer or exome-only subset.
  • Generic calibration supplied for this case: PM2 supporting <= 0.0001, ClinGen SVI 2020 recommendation (cited in the prompt with PMID:25741868).
Sources
PP3 ModerateACMGMet at moderate strength: missense REVEL score 0.904 exceeds the PP3 moderate threshold of 0.773. Details ▾Hide ▴
Reasoning

The variant is a missense substitution, so the governing generic rule selects the REVEL path only. REVEL is 0.904, meeting the supplied PP3 moderate threshold of >= 0.773 from the ClinGen SVI REVEL calibration (Pejaver et al. 2022, PMID:36413997). SpliceAI is not used for this missense PP3 assessment, and BayesDel is not available for generic ACMG strength calibration.

Rule
PP3: Multiple lines of computational evidence support a deleterious effect on the gene or gene product (conservation, evolutionary, splicing impact, etc.). ... PP3 (moderate): >= 0.773 — ClinGen SVI REVEL calibration (Pejaver et al. 2022, Am J Hum Genet) (PMID:36413997)
Evidence considered
  • NM_005896.4:c.394C>A is an exonic missense variant producing NP_005887.2:p.(Arg132Ser); the applicable generic computational path is REVEL only.
  • Local REVEL lookup reports score 0.904 for NC_000002.12:g.208248389G>T (source_registry key: revel).
  • REVEL 0.904 meets the supplied PP3 moderate cutoff >= 0.773 from the ClinGen SVI REVEL calibration (Pejaver et al. 2022, PMID:36413997).
  • The available SpliceAI max delta 0.609 was not counted because the generic rule assigns missense variants to the REVEL path only; BayesDel was not counted because no generic ACMG-strength calibration is established.
Sources
revel

Not met · 8 · evaluated, threshold not reached

PS1 ACMG_2015Not met: no pathogenic IDH1 p.Arg132Ser variant caused by a different nucleotide change was established in the reviewed evidence. Details ▾Hide ▴
Reasoning

The variant is IDH1 p.Arg132Ser from NM_005896.4:c.394C>A. The reviewed literature reports this exact amino-acid substitution, but no source establishes a pathogenic p.Arg132Ser variant caused by a different nucleotide change. Reports of the same nucleotide change or the same amino-acid substitution do not independently satisfy PS1, and no alternate-nucleotide pathogenic comparator was identified.

Rule
Same amino acid change as a previously established pathogenic variant regardless of nucleotide change. ... Caveat: Beware of changes that impact splicing rather than at the amino acid/protein level.
Evidence considered
  • PMID:21760534 reports two IDH1-R132S cases, but does not report an alternate nucleotide change or establish a separate pathogenic comparator.
  • PMID:19935646 experimentally includes IDH1 R132S, but the reported construct is the same amino-acid substitution and does not establish an alternate-nucleotide pathogenic variant.
  • PMID:21912393 reports three IDH1 R132S cases in a myelofibrosis cohort, without an alternate-nucleotide pathogenic comparator.
Still missing
  • A validated alternate-nucleotide IDH1 p.Arg132Ser pathogenic variant is not documented in the available evidence.
Sources
PP5 ACMG_2015Not met: ClinVar has only a single-submitter Pathogenic classification, with zero expert-panel submissions, so the exact-variant PP5 requirement is not satisfied. Details ▾Hide ▴
Reasoning

ClinVar contains an exact-variant Pathogenic submission from one clinical laboratory with criteria provided, single submitter status, and no expert-panel submission. This is not a ClinVar expert-panel classification. The reviewed literature provides case and functional observations but does not constitute a reputable recent source reporting this exact variant as pathogenic with evidence unavailable for independent evaluation under PP5.

Rule
Reputable source recently reports variant as pathogenic, but the evidence is not available to the laboratory to perform an independent evaluation.
Evidence considered
  • ClinVar exact variant NM_005896.4:c.394C>A (p.Arg132Ser): Pathogenic, criteria provided, single submitter; expert-panel submissions = 0.
  • The ClinVar submission audit identifies one usable clinical-laboratory submission and zero usable expert-panel criterion leads.
Sources
BA1 ACMG_2015Not met: gnomAD v4.1 observed 0/1,613,196 alleles (AF 0), below the generic BA1 threshold of 5%. Details ▾Hide ▴
Reasoning

BA1 is not met. The variant is absent from gnomAD v2.1 and has an all-comers gnomAD v4.1 allele count of 0/1,613,196 (AF 0; homozygotes 0), far below the generic stand-alone threshold of 0.05. gnomAD v4.1 reports grpmax FAF as null, so a filtering FAF cannot be independently confirmed; there is nevertheless no observed population frequency supporting BA1. The variant is a missense SNV, so the ACMG/AMP indel calling caveat does not apply.

Rule
Allele frequency is above 5% in Exome Sequencing Project, 1000 Genomes or Exome Aggregation Consortium.
Evidence considered
  • gnomAD v2.1 reports the variant as absent.
  • gnomAD v4.1 all-comers data report total AC=0, AN=1,613,196, AF=0, and homozygotes=0; grpmax FAF is null.
  • Generic calibration supplied for this case: BA1 >= 0.05, ACMG/AMP 2015 stand-alone benign allele frequency (PMID:25741868).
Still missing
  • The gnomAD v4.1 grpmax FAF field is null, so the filtering FAF value cannot be independently confirmed.
Sources
BS1 ACMGNot met: gnomAD v4.1 observed AF 0 from 0/1,613,196 alleles, below the generic BS1 default of 1%. Details ▾Hide ▴
Reasoning

BS1 is not met. The variant is absent from gnomAD v2.1 and has an all-comers gnomAD v4.1 allele count of 0/1,613,196 (AF 0; homozygotes 0), below the generic default threshold of 0.01. The required filtering metric, grpmax FAF, is null in the supplied gnomAD v4.1 record, but no observed frequency exceeds the disorder-appropriate threshold. Because the observed frequency is zero, a maximum-credible-frequency calculation is not needed to reject BS1; no elevated ancestry-specific frequency or founder signal is present.

Rule
Allele frequency is greater than expected for disorder. ... BS1 (strong): >= 0.01 — Generic SVI default; per-gene derivation preferred (Whiffin et al. 2017) (PMID:28518168)
Evidence considered
  • gnomAD v2.1 reports the variant as absent.
  • gnomAD v4.1 all-comers data report total AC=0, AN=1,613,196, AF=0, and homozygotes=0; grpmax FAF is null.
  • Generic calibration supplied for this case: BS1 >= 0.01; the generic rule is that allele frequency must be greater than expected for the disorder, with Whiffin et al. 2017 (PMID:28518168) preferred for disorder-specific derivation.
Still missing
  • A disorder-specific prevalence, penetrance, and allelic-heterogeneity model is not available, although it is unnecessary to reject BS1 with observed AF 0.
  • The gnomAD v4.1 grpmax FAF field is null, so the filtering FAF value cannot be independently confirmed.
Sources
BS2 ACMG_2015Not met: no healthy adult carrier is reported, and gnomAD shows 0 observed alleles and 0 homozygotes. Details ▾Hide ▴
Reasoning

BS2 is not met. No healthy adult individual carrying NM_005896.4:c.394C>A (IDH1 p.Arg132Ser) is reported in the supplied evidence. gnomAD shows 0 observed alleles and 0 homozygotes, which cannot establish the required observation in a healthy adult; no disease-specific full-penetrance early-onset context is available to support this criterion.

Rule
Observed in a healthy adult individual for a recessive (homozygous), dominant (heterozygous), or X-linked (hemizygous) disorder, with full penetrance expected at an early age.
Evidence considered
  • gnomAD v2.1 reports the variant as absent.
  • gnomAD v4.1 reports total AC=0, AN=1,613,196, and homozygotes=0; this is absence of an observed carrier, not a positive healthy-adult observation.
  • No supplied source reports a healthy adult individual carrying this variant.
Still missing
  • No individual-level healthy-adult carrier observation or disease-specific penetrance assessment is available.
Sources
BS3 ACMG_2015Not met: IDH1 R132S showed gain-of-function 2-hydroxyglutarate production, not absence of a damaging effect on protein function or splicing. Details ▾Hide ▴
Reasoning

BS3 is not met. The directly relevant variant-specific functional study reports that IDH1 p.Arg132Ser produces a gain of function in NADPH-dependent reduction of alpha-ketoglutarate to 2-hydroxyglutarate, rather than showing no damaging effect on protein function or splicing. No variant-specific benign functional result, normal activity result, or normal splicing result was identified.

Rule
Well-established in vitro or in vivo functional studies show no damaging effect on protein function or splicing.
Evidence considered
  • Dang et al. 2009, Cancer-associated IDH1 mutations produce 2-hydroxyglutarate: recombinant IDH1 R132S showed gain-of-function NADPH-dependent alpha-ketoglutarate reduction to 2-hydroxyglutarate, directly contradicting a benign functional interpretation for this variant.
Sources
BP4 ACMGNot met: missense REVEL score 0.904 is above the BP4 supporting threshold of 0.29. Details ▾Hide ▴
Reasoning

The variant is a missense substitution, so BP4 must be evaluated through the REVEL path only. REVEL is 0.904, which is above the supplied BP4 supporting threshold of <= 0.29; therefore BP4 is not met. The SpliceAI max delta of 0.609 is not applicable to the missense BP4 path, and BayesDel has no generic ACMG-strength calibration.

Rule
BP4: Multiple lines of computational evidence suggest no impact on gene or gene product (conservation, evolutionary, splicing impact, etc) ... BP4 (supporting): <= 0.29 — ClinGen SVI REVEL calibration (Pejaver et al. 2022, Am J Hum Genet) (PMID:36413997)
Evidence considered
  • NM_005896.4:c.394C>A is an exonic missense variant producing NP_005887.2:p.(Arg132Ser); the applicable generic computational path is REVEL only.
  • Local REVEL lookup reports score 0.904 for NC_000002.12:g.208248389G>T (source_registry key: revel).
  • REVEL 0.904 does not meet the supplied BP4 supporting cutoff <= 0.29 from the ClinGen SVI REVEL calibration (Pejaver et al. 2022, PMID:36413997).
  • The available SpliceAI max delta 0.609 was not counted because the generic rule assigns missense variants to the REVEL path only; BayesDel was not counted because no generic ACMG-strength calibration is established.
Sources
revel
BP6 ACMG_2015Not met: no exact-variant ClinVar expert-panel Benign or Likely benign classification is present; the available ClinVar submission is single-submitter Pathogenic. Details ▾Hide ▴
Reasoning

The exact-variant ClinVar record is Pathogenic from a single clinical laboratory and has no expert-panel submission. No exact-variant ClinVar expert-panel classification of Benign or Likely benign is present, and no qualifying reputable benign report was identified.

Rule
Reputable source recently reports variant as benign, but the evidence is not available to the laboratory to perform an independent evaluation.
Evidence considered
  • ClinVar exact variant NM_005896.4:c.394C>A (p.Arg132Ser): Pathogenic, criteria provided, single submitter; expert-panel submissions = 0.
  • The ClinVar submission audit reports zero expert-panel submissions and no benign expert-panel assertion.
Sources

Not assessed · 12 · no assessment recorded

PS2 ACMG_2015Not assessed: no proband-level parental testing, confirmed maternity and paternity, or family-history information is provided for IDH1 p.Arg132Ser. Details ▾Hide ▴
Reasoning

PS2 cannot be assessed because the available evidence does not document a germline proband with confirmed maternity and paternity, parental variant testing, or absence of family history. The available variant-specific literature concerns IDH1 p.Arg132Ser in somatic cancer cohorts and does not establish a de novo germline occurrence.

Rule
De novo (both maternity and paternity confirmed) in a patient with the disease and no family history.
Evidence considered
  • No case-level germline segregation or de novo testing data are available for NM_005896.4:c.394C>A (IDH1 p.Arg132Ser).
  • The available variant-specific publications describe somatic IDH1 p.Arg132Ser observations in cancer cohorts and do not provide confirmed germline de novo evidence.
Still missing
  • A germline proband record with phenotype and disease diagnosis is not provided.
  • Confirmed maternity and paternity are not documented.
  • Parental testing for the variant is not documented.
  • Family history status is not documented.
PS4 ACMG_2015Not assessed: affected-case reports exist, but no matched control counts were provided, so the required OR >5.0 and 95% CI excluding 1.0 cannot be calculated. Details ▾Hide ▴
Reasoning

The PS4-screened literature was verified. PMID:21912393 reports IDH1 p.R132S in 3 of 301 patients with chronic-phase primary myelofibrosis, and PMID:21760534 reports R132S in 2 of 94 successfully sequenced diffuse-glioma cases. These are affected-case cohorts without unaffected or population control counts for the same disease and ancestry. gnomAD v4.1 reports 0/1,613,196 alleles, but the case cohorts are not shown to be ancestry-matched and no valid case-control comparison is provided. Therefore an odds ratio and 95% confidence interval suitable for the PS4 threshold cannot be computed from the available evidence; the evidence does not establish the required significant increase compared with controls.

Rule
The prevalence of the variant in affected individuals is significantly increased compared to the prevalence in controls. ... Note 1: Relative risk (RR) or odds ratio (OR), as obtained from case-control studies, is >5.0 and the confidence interval around the estimate of RR or OR does not include 1.0.
Evidence considered
  • PMID:21912393, Results paragraph 2: 3 IDH1 R132S observations among 301 chronic-phase primary myelofibrosis patients; the paper is a case cohort and does not provide unaffected controls for R132S.
  • PMID:21760534, Results, Genetic Analysis: 2 IDH1-R132S observations among 94 successfully sequenced diffuse-glioma cases; no unaffected controls or control allele frequency are reported.
  • gnomAD v4.1: 0/1,613,196 alleles for NM_005896.4:c.394C>A, but no ancestry matching to the affected cohorts is established; therefore this cannot supply a valid matched case-control comparison.
  • No odds ratio or 95% confidence interval was computed because the required matched control data are absent.
Still missing
  • A disease- and ancestry-matched unaffected/control cohort with exact IDH1 p.R132S counts is required to calculate OR and its 95% CI.
Sources
PM3 ACMG_2015Not assessed: no recessive disorder, affected germline proband, pathogenic partner, or parent/offspring phasing demonstrates IDH1 p.Arg132Ser in trans. Details ▾Hide ▴
Reasoning

PM3 cannot be assessed from the available evidence. The case documents IDH1 p.Arg132Ser in somatic cancer observations, but does not establish a recessive disorder, an affected proband with a relevant germline phenotype, a second pathogenic variant, or parental/offspring testing demonstrating that the variants are in trans. The cited cancer literature reports co-occurring somatic mutations in some tumors, but this does not establish germline allelic phase.

Rule
For recessive disorders, detected in trans with a pathogenic variant
Evidence considered
  • The available case evidence concerns IDH1 p.Arg132Ser in somatic cancer cohorts and does not document germline inheritance, a recessive phenotype, a pathogenic allele in trans, or parental/offspring phasing.
  • Co-occurrence of IDH1 p.Arg132Ser with other somatic mutations in tumor studies is not evidence of germline trans phase.
Still missing
  • A defined recessive IDH1 disorder and inheritance model are not documented.
  • No affected germline proband with a second pathogenic variant is documented.
  • No parental or offspring testing establishes trans phase.
PM5 ACMG_2015Not assessed: other Arg132 substitutions are reported, but no cited record establishes a different Arg132 missense variant as pathogenic under the generic rule. Details ▾Hide ▴
Reasoning

The evidence documents other IDH1 substitutions at Arg132, including R132H, R132C, R132L and R132G, and reports recurrent R132 substitutions in cancer. However, the available cited records do not establish a specific different missense Arg132 variant as pathogenic under the generic ACMG/AMP germline rule; the target's single-submitter ClinVar classification cannot be used as a pathogenic comparator. Therefore PM5 cannot be adjudicated without a validated pathogenic comparator record for a different Arg132 missense change.

Rule
Novel missense change at an amino acid residue where a different missense change determined to be pathogenic has been seen before. ... Caveat: Beware of changes that impact splicing rather than at the amino acid/protein level.
Evidence considered
  • PMID:19935646 reports R132H, R132C, R132L and R132S functional constructs, but does not provide a pathogenic classification for a different Arg132 missense comparator.
  • PMID:21326614 describes R132H, R132C, R132S, R132L and R132G as recurrent glioma-associated substitutions, but does not establish a specific comparator as pathogenic under this germline ACMG criterion.
  • PMID:21760534 reports R132C and R132G in addition to R132S in glioma specimens, without a pathogenic comparator determination.
  • PMID:23630074 summarizes multiple IDH1 Arg132 substitutions, but does not provide a specific pathogenic determination for a different Arg132 missense variant.
Still missing
  • A validated source establishing a different IDH1 Arg132 missense variant as pathogenic is required.
Sources
PM6 ACMG_2015Not assessed: no presumed de novo germline occurrence is documented, and parental maternity or paternity information is unavailable for this variant. Details ▾Hide ▴
Reasoning

PM6 cannot be assessed because no presumed de novo germline occurrence is documented. There is no proband-level parental testing, no statement that maternity and paternity were unconfirmed, and no germline family or phenotype report for this variant.

Rule
Assumed de novo, but without confirmation of paternity and maternity.
Evidence considered
  • No case-level presumed de novo germline evidence is available for NM_005896.4:c.394C>A (IDH1 p.Arg132Ser).
  • The available literature reports somatic cancer findings rather than a germline de novo case with parental information.
Still missing
  • A germline proband with the relevant disease phenotype is not identified.
  • Parental variant results are not reported.
  • Whether maternity and paternity were confirmed or unconfirmed is not reported.
PP1 ACMG_2015Not assessed: zero affected relatives, informative meioses, or variant-positive familial segregation observations are reported for IDH1 p.Arg132Ser. Details ▾Hide ▴
Reasoning

PP1 cannot be assessed because no affected family members, informative meioses, variant-positive relatives, or phenotype concordance data are provided. The available reports of IDH1 p.Arg132Ser are somatic cancer cohort observations and do not constitute familial cosegregation evidence.

Rule
Co-segregation with disease in multiple affected family members in a gene definitively known to cause the disease.
Evidence considered
  • No familial cosegregation data are available for NM_005896.4:c.394C>A (IDH1 p.Arg132Ser).
  • The available variant-specific publications describe somatic cancer cohorts, not affected families with genotype-phenotype segregation.
Still missing
  • No affected family members are described.
  • No informative meioses or pedigree are provided.
  • No relatives have reported genotype and phenotype results.
  • Phenotype consistency among relatives cannot be evaluated.
PP2 ACMG_2015Not assessed: gene-level benign missense rate and a qualifying common missense disease mechanism are not established by the available evidence. Details ▾Hide ▴
Reasoning

The available evidence describes recurrent IDH1 missense substitutions and an active-site hotspot, but it does not provide the gene-level benign missense rate or a sufficiently established disease mechanism meeting both PP2 requirements. The absence of this individual variant from gnomAD cannot substitute for a gene-level benign missense assessment.

Rule
Missense variant in a gene that has a low rate of benign missense variation and where missense variants are a common mechanism of disease.
Still missing
  • Gene-level evidence for a low rate of benign IDH1 missense variation is missing.
  • Gene-level evidence establishing missense variants as a common mechanism of the relevant germline disease is missing.
PP4 ACMG_2015Not assessed: no patient phenotype or family-history detail is available to establish a highly specific phenotype for a single genetic etiology. Details ▾Hide ▴
Reasoning

The available evidence identifies IDH1 p.Arg132Ser in somatic myelofibrosis and glioma cohorts, but it does not provide the patient's phenotype, family history, or a phenotype highly specific for a single genetic etiology. The multiple cancer contexts reported for IDH1 R132S do not substitute for a specific clinical phenotype assessment.

Rule
Patient’s phenotype or family history is highly specific for a disease with a single genetic etiology.
Evidence considered
  • The reviewed publications report tumor cohorts and molecular findings rather than a phenotype-specific clinical presentation for this case.
  • No case-level phenotype or family-history information sufficient for PP4 was available.
Still missing
  • Patient-level phenotype, family history, diagnostic context, and an assessment of whether the phenotype is specific to one genetic etiology are required.
Sources
BS4 ACMG_2015Not assessed: no affected relatives with documented negative variant testing are reported, so lack of segregation cannot be evaluated. Details ▾Hide ▴
Reasoning

BS4 cannot be assessed because no affected family members with documented absence of the variant are reported. The case contains no pedigree, relative genotypes, phenotype evaluations, or non-segregation observations, so lack of segregation cannot be distinguished from missing family data.

Rule
Lack of segregation in affected members of a family.
Evidence considered
  • No affected-family non-segregation evidence is available for NM_005896.4:c.394C>A (IDH1 p.Arg132Ser).
  • The available variant-specific reports are somatic cancer observations and provide no family-level testing data.
Still missing
  • No affected relatives are identified.
  • No relative genotypes are reported.
  • No family phenotype assessments or pedigree are provided.
  • Potential phenocopies and multiple pathogenic variants cannot be evaluated.
BP1 ACMG_2015Not assessed: the available evidence does not show that IDH1 disease is caused primarily by truncating variants. Details ▾Hide ▴
Reasoning

The available evidence does not establish that IDH1-related disease is caused primarily by truncating variants. Reports of recurrent somatic IDH1 missense substitutions and gain-of-function biochemical findings do not satisfy the gene-level BP1 requirement, and no qualifying truncating-versus-missense disease spectrum is documented in the supplied sources.

Rule
Missense variant in a gene for which primarily truncating variants are known to cause disease.
Still missing
  • A gene-level disease spectrum demonstrating predominantly truncating IDH1 pathogenic variants is missing.
BP2 ACMG_2015Not assessed: no fully penetrant dominant disorder or validated evidence places IDH1 p.Arg132Ser in trans or cis with a pathogenic variant. Details ▾Hide ▴
Reasoning

BP2 cannot be assessed from the available evidence. No fully penetrant dominant IDH1 disorder is established for this case, and no pathogenic variant in trans or pathogenic variant in cis with IDH1 p.Arg132Ser has been documented by parental testing, offspring testing, tumor phasing, or another validated phasing method.

Rule
Observed in trans with a pathogenic variant for a fully penetrant dominant gene/disorder or observed in cis with a pathogenic variant in any inheritance pattern.
Evidence considered
  • The available evidence does not document a pathogenic partner variant or validated cis/trans phasing for IDH1 p.Arg132Ser.
  • Somatic co-occurrence reports do not establish the cis/trans relationship required for BP2.
Still missing
  • A fully penetrant dominant IDH1 disorder is not documented for this case.
  • No pathogenic partner variant is documented with validated cis or trans phase.
BP5 ACMG_2015Not assessed: JAK2V617F co-occurrence is reported for the IDH-mutated cohort, but not definitively for the exact R132S case or as its alternate disease basis. Details ▾Hide ▴
Reasoning

PMID:21912393 reports IDH1 R132S in a 301-patient myelofibrosis cohort and describes IDH mutations occurring with JAK2V617F, but the supplied extraction does not establish that each R132S observation had JAK2V617F or that JAK2V617F was an alternate molecular basis for the disease in the relevant case. No case-level alternate molecular-basis evidence sufficient for BP5 is available.

Rule
Variant found in a case with an alternate molecular basis for disease.
Evidence considered
  • PMID:21912393 reports 3 IDH1 R132S cases among 301 patients and discusses concomitant JAK2V617F among IDH-mutated patients, but does not establish the co-occurring genotype for each R132S carrier in the extracted evidence.
  • No independent molecular diagnosis is documented for the specific variant-positive case being adjudicated.
Still missing
  • Case-level confirmation that an exact R132S carrier had an independent molecular cause of the relevant disease is required.
Sources
Not applicable · 4· recorded as not applicable Show reasons ▾Hide reasons ▴
PVS1 N/ANot applicable: PVS1 requires a null variant (nonsense, frameshift, canonical splice, start-loss or stop-loss), and this is a missense variant. Details ▾Hide ▴
Reasoning

PVS1 (ClinGen SVI PVS1 recommendations, PMC6185798, pvs1_generic_framework) applies only to null variant classes — nonsense, frameshift, canonical ±1/2 splice-consensus, translation-initiation-codon loss, and stop-loss variants — each expected to trigger nonsense-mediated decay or otherwise abolish normal protein function. NM_005896.4:c.394C>A in IDH1 is a missense substitution predicted to produce NP_005887.2:p.(Arg132Ser). As a result, no null-variant mechanism (nonsense-mediated decay, truncation, or canonical splice disruption) is triggered by this variant class, so PVS1's structural prerequisite is not met by this variant class. No VCEP criteria specification covers PVS1 for IDH1, so the generic ACMG/AMP 2015 definition applies. This determination was made deterministically from the variant's consequence class, prior to LLM adjudication.

Rule
deterministic_prefilter: requires_null_variant_class
Evidence considered
  • Deterministic consequence classification: missense (prefetch.json normalized protein consequence)
  • VCEP criterion policy: absent
Sources
pvs1_generic_framework ↗generic_acmg_combination_rules
PM4 N/ANot applicable: PM4 requires a protein-length change, and this is a missense variant. Details ▾Hide ▴
Reasoning

PM4 (Richards et al. 2015, PMID:25741868) applies to protein length changes: in-frame insertions/deletions in a non-repetitive region, or stop-loss variants that extend the protein past the reference stop codon. NM_005896.4:c.394C>A in IDH1 is a missense substitution predicted to produce NP_005887.2:p.(Arg132Ser). As a result, no change in protein length occurs, so there is nothing for this criterion to evaluate, so PM4's structural prerequisite is not met by this variant class. No VCEP criteria specification covers PM4 for IDH1, so the generic ACMG/AMP 2015 definition applies. This determination was made deterministically from the variant's consequence class, prior to LLM adjudication.

Rule
deterministic_prefilter: requires_stop_loss_or_nonrepeat_indel
Evidence considered
  • Deterministic consequence classification: missense (prefetch.json normalized protein consequence)
  • VCEP criterion policy: absent
Sources
pvs1_generic_framework ↗generic_acmg_combination_rules
BP3 N/ANot applicable: BP3 requires an in-frame indel in a repeat region, and this is a missense variant. Details ▾Hide ▴
Reasoning

BP3 (Richards et al. 2015, PMID:25741868) applies to in-frame insertions/deletions located in a repetitive region without a known function. NM_005896.4:c.394C>A in IDH1 is a missense substitution predicted to produce NP_005887.2:p.(Arg132Ser). As a result, the variant does not alter protein length within a repeat region, so there is nothing for this criterion to evaluate, so BP3's structural prerequisite is not met by this variant class. No VCEP criteria specification covers BP3 for IDH1, so the generic ACMG/AMP 2015 definition applies. This determination was made deterministically from the variant's consequence class, prior to LLM adjudication.

Rule
deterministic_prefilter: requires_repeat_region_indel
Evidence considered
  • Deterministic consequence classification: missense (prefetch.json normalized protein consequence)
  • VCEP criterion policy: absent
Sources
pvs1_generic_framework ↗generic_acmg_combination_rules
BP7 N/ANot applicable: BP7 requires a synonymous variant, and this is a missense variant. Details ▾Hide ▴
Reasoning

BP7 (Richards et al. 2015, PMID:25741868) is defined for a synonymous (silent) variant for which splicing prediction algorithms predict no impact to the splice consensus sequence and the nucleotide is not highly conserved. NM_005896.4:c.394C>A in IDH1 is a missense substitution predicted to produce NP_005887.2:p.(Arg132Ser). As a result, the encoded protein sequence is altered, so the criterion's silent-variant premise does not hold regardless of any splicing prediction, so BP7's structural prerequisite is not met by this variant class. No VCEP criteria specification covers BP7 for IDH1, so the generic ACMG/AMP 2015 definition applies. This determination was made deterministically from the variant's consequence class, prior to LLM adjudication.

Rule
deterministic_prefilter: requires_synonymous
Evidence considered
  • Deterministic consequence classification: missense (prefetch.json normalized protein consequence)
  • VCEP criterion policy: absent
Sources
generic_acmg_combination_rules

Identifiers

Gene
IDH1
Transcript
NM_005896.4
Coding (HGVS c.)
NM_005896.4:c.394C>A
Protein (HGVS p.)
NP_005887.2:p.(Arg132Ser)
GRCh38
chr2:208248389 G>T
GRCh37
chr2:209113113 G>T
Location and type
Exon 4 · missense
ClinVar
375893, 156444
COSMIC
COSV61615649

Gene diagram

Every interpreted variant in IDH1, mapped onto the exon structure of NM_005896.4. Select a row to find it on the plot.

IDH1NM_005896.4
Fetching transcript structure from UCSC…
gnomAD v4.1 0 / 1,613,196 alleles AF 0 · 0 homozygotes
gnomAD v2.1 Allele count data not recorded
gnomAD-Canada v1.0 Allele count data not recorded

By genetic ancestry

gnomAD v4.1

AF 0 · 0 / 1,613,196 alleles · 0 hom
No alternate alleles recorded in the displayed ancestry groups.

Statements

gnomAD v4.1

This variant is present in gnomAD v4.1 (AF= 0; MAF= 0.00000%, 0/1613196 alleles, homozygotes = 0) and has highest observed frequency in the African/African American population (AF= 0; MAF= 0.00000%, 0/74792 alleles, homozygotes = 0).

gnomAD v2.1

Absent from gnomAD v2.1.

gnomAD-Canada

Not available in gnomAD-Canada v1.0.

SpliceAI and Pangolin

SpliceAI acceptor lossat +260 bp
0.021
SpliceAI acceptor gainat -75 bp
0.001
SpliceAI donor lossat -20 bp
0.477
SpliceAI donor gainat +34 bp
0.609
Pangolin splice lossmagnitude shown
-0.409
Pangolin splice gain
0.434

Other predictors

REVEL
0.904
BayesDel
0.419

How the predictions were used

PP3 ModerateACMGMet at moderate strength: missense REVEL score 0.904 exceeds the PP3 moderate threshold of 0.773. Details ▾Hide ▴
Reasoning

The variant is a missense substitution, so the governing generic rule selects the REVEL path only. REVEL is 0.904, meeting the supplied PP3 moderate threshold of >= 0.773 from the ClinGen SVI REVEL calibration (Pejaver et al. 2022, PMID:36413997). SpliceAI is not used for this missense PP3 assessment, and BayesDel is not available for generic ACMG strength calibration.

Rule
PP3: Multiple lines of computational evidence support a deleterious effect on the gene or gene product (conservation, evolutionary, splicing impact, etc.). ... PP3 (moderate): >= 0.773 — ClinGen SVI REVEL calibration (Pejaver et al. 2022, Am J Hum Genet) (PMID:36413997)
Evidence considered
  • NM_005896.4:c.394C>A is an exonic missense variant producing NP_005887.2:p.(Arg132Ser); the applicable generic computational path is REVEL only.
  • Local REVEL lookup reports score 0.904 for NC_000002.12:g.208248389G>T (source_registry key: revel).
  • REVEL 0.904 meets the supplied PP3 moderate cutoff >= 0.773 from the ClinGen SVI REVEL calibration (Pejaver et al. 2022, PMID:36413997).
  • The available SpliceAI max delta 0.609 was not counted because the generic rule assigns missense variants to the REVEL path only; BayesDel was not counted because no generic ACMG-strength calibration is established.
Sources
revel
BP4 ACMGNot met: missense REVEL score 0.904 is above the BP4 supporting threshold of 0.29. Details ▾Hide ▴
Reasoning

The variant is a missense substitution, so BP4 must be evaluated through the REVEL path only. REVEL is 0.904, which is above the supplied BP4 supporting threshold of <= 0.29; therefore BP4 is not met. The SpliceAI max delta of 0.609 is not applicable to the missense BP4 path, and BayesDel has no generic ACMG-strength calibration.

Rule
BP4: Multiple lines of computational evidence suggest no impact on gene or gene product (conservation, evolutionary, splicing impact, etc) ... BP4 (supporting): <= 0.29 — ClinGen SVI REVEL calibration (Pejaver et al. 2022, Am J Hum Genet) (PMID:36413997)
Evidence considered
  • NM_005896.4:c.394C>A is an exonic missense variant producing NP_005887.2:p.(Arg132Ser); the applicable generic computational path is REVEL only.
  • Local REVEL lookup reports score 0.904 for NC_000002.12:g.208248389G>T (source_registry key: revel).
  • REVEL 0.904 does not meet the supplied BP4 supporting cutoff <= 0.29 from the ClinGen SVI REVEL calibration (Pejaver et al. 2022, PMID:36413997).
  • The available SpliceAI max delta 0.609 was not counted because the generic rule assigns missense variants to the REVEL path only; BayesDel was not counted because no generic ACMG-strength calibration is established.
Sources
revel
BP7 N/ANot applicable: BP7 requires a synonymous variant, and this is a missense variant. Details ▾Hide ▴
Reasoning

BP7 (Richards et al. 2015, PMID:25741868) is defined for a synonymous (silent) variant for which splicing prediction algorithms predict no impact to the splice consensus sequence and the nucleotide is not highly conserved. NM_005896.4:c.394C>A in IDH1 is a missense substitution predicted to produce NP_005887.2:p.(Arg132Ser). As a result, the encoded protein sequence is altered, so the criterion's silent-variant premise does not hold regardless of any splicing prediction, so BP7's structural prerequisite is not met by this variant class. No VCEP criteria specification covers BP7 for IDH1, so the generic ACMG/AMP 2015 definition applies. This determination was made deterministically from the variant's consequence class, prior to LLM adjudication.

Rule
deterministic_prefilter: requires_synonymous
Evidence considered
  • Deterministic consequence classification: missense (prefetch.json normalized protein consequence)
  • VCEP criterion policy: absent
Sources
generic_acmg_combination_rules

Statement

In silico

SpliceAI predicts possible splice impact for this variant (max delta score = 0.61). REVEL score = 0.904. BayesDel score = 0.419369.

8 paper records listed. 1 cited in the classification.

Cited in the classification

  • Cancer-associated IDH1 mutations produce 2-hydroxyglutarate.
    Dang L et al. · 2009 Dec 10
    The paper explicitly studied IDH1 p.R132S as a recombinant mutant and reports that R132S, like R132H, R132C and R132L, produces gain-of-function NADPH-dependent reduction of alpha-ketoglutarate to 2-hydroxyglutarate. It also describes cancer-associated IDH1 mutations at a single amino-acid residue of the IDH1 active site.
    → PS3 · supporting → PM1 · moderate Names this variant
    PMID 19935646 ↗
    Source detail
    Similar to R132H mutant protein, R132C, R132L, and R132S mutations all result in a gain-of-function for NADPH-dependent reduction of αKG (Supplementary Figure 4).

    Location Results, section "Mutant IDH1 directly converts αKG to 2HG"; Discussion

    Context Recombinant human IDH1 R132S protein was generated by site-directed mutagenesis, expressed and purified from E. coli, and assessed in enzymatic assays.

Other recorded publications

  • Value and limitations of immunohistochemistry and gene sequencing for detection of the IDH1-R132H mutation in diffuse glioma biopsy specimens.
    The paper reports two IDH1-R132S cases identified by sequencing among 94 cases with successful genetic analysis, one anaplastic astrocytoma and one secondary glioblastoma. It also reports R132C and R132G cases, but does not provide a pathogenic comparator determination.
    Names this variant
    PMID 21760534 ↗
    Quoted passage
    In 7 (7.4%) of the 94 cases, we detected non-R132H mutations ofIDH1 as follows: 3 with IDH1-R132C mutation (1 diffuse astrocytoma, 1 oligodendroglioma, 1 anaplastic astrocytoma), 2 with IDH1-R132S mutation (1 anaplastic astrocytoma, 1 secondary glioblastoma), and 2 with IDH1-R132G mutations (1 diffuse astrocytoma, 1 anaplastic astrocytoma).

    Results, Genetic Analysis; Discussion

  • IDH mutations in primary myelofibrosis predict leukemic transformation and shortened survival: clinical evidence for leukemogenic collaboration with JAK2V617F.
    The paper identifies IDH1 p.R132S in three of 301 patients with chronic-phase primary myelofibrosis and reports R132C as another IDH1 substitution in the cohort; prognostic analyses were for the combined IDH-mutated group rather than R132S specifically.
    Names this variant
    PMID 21912393 ↗
    Quoted passage
    The mutant IDH was detected in 12 patients (4%): 7 IDH2 (5 R140Q, 1 R140W and 1 R172G) and 5 IDH1 (3 R132S and 2 R132C).

    Results, paragraph 2

  • Differential prognostic effect of IDH1 versus IDH2 mutations in myelodysplastic syndromes: a Mayo Clinic study of 277 patients.
    No paper-specific finding is recorded.
    PMID 22033490 ↗
  • What a difference a hydroxyl makes: mutant IDH, (R)-2-hydroxyglutarate, and cancer.
    Losman JA et al. · 2013
    The review explicitly includes IDH1 R132S among grouped IDH1 Arg132 substitutions reported in glioma, AML and chondrosarcoma, but does not provide a specific pathogenic determination for a different Arg132 missense variant.
    Names this variant
    PMID 23630074 ↗
    Quoted passage
    IDH1 R132C/S/L/G/V 5%–8% ... IDH1 R132C/S/L/G/P 15%–30% ... IDH1 R132G/H/L/S 30%–50%

    Table 1, "Frequency of IDH1 and IDH2 mutant alleles in human cancers"

  • 2-hydroxyglutarate production, but not dominant negative function, is conferred by glioma-derived NADP-dependent isocitrate dehydrogenase mutations.
    Jin G et al. · 2011
    The paper identifies IDH1 R132S as a recurrent glioma-associated substitution alongside R132H, R132C, R132L and R132G. Grouped R132 mutant experiments show production of R-2-hydroxyglutarate, but no separate R132S-specific pathogenic determination is supplied.
    Names this variant
    PMID 21326614 ↗
    Quoted passage
    R132H is the most common IDH1 substitution in gliomas, followed by R132C, R132S, R132L, and R132G.

    Introduction, first paragraph; Results, sections "IDH1 R132 mutants bind IDH1-WT" and "IDH mutants produce 2HG"

  • Pan-cancer repository of validated natural and cryptic mRNA splicing mutations.
    No paper-specific finding is recorded.
    PMID 31275557 ↗
  • American College of Medical Genetics and Genomics technical standards and guidelines: microarray analysis for chromosome abnormalities in neoplastic disorders.
    Cooley LD et al. · 2013
    No paper-specific finding is recorded.
    PMID 23619274 ↗

Screenshots represent source records captured during evidence collection. Select one to view the recorded source content.

All source links

Statements for reports

The evidence statements recorded by the interpretation pipeline. They have not been reinterpreted by the page.

gnomAD v4.1

This variant is present in gnomAD v4.1 (AF= 0; MAF= 0.00000%, 0/1613196 alleles, homozygotes = 0) and has highest observed frequency in the African/African American population (AF= 0; MAF= 0.00000%, 0/74792 alleles, homozygotes = 0).

gnomAD v2.1

Absent from gnomAD v2.1.

gnomAD-Canada

Not available in gnomAD-Canada v1.0.

ClinVar

This variant has been reported in ClinVar as Pathogenic (1 clinical laboratory). (ClinVarID = 375893)

In silico

SpliceAI predicts possible splice impact for this variant (max delta score = 0.61). REVEL score = 0.904. BayesDel score = 0.419369.

Functional

OncoKB identified variant-specific curated literature and context relevant to functional review; curated oncogenicity label: Likely Oncogenic.

Somatic

This variant lies in a statistically significant hotspot. This variant has previously been reported in somatic cancers (COSMIC; COSV61615649, n = 217 times).

Cancer Hotspots

This variant lies in a statistically significant hotspot.