The MTHFR NM_005957.5:c.665C>T (NP_005948.3:p.(Ala222Val)) missense variant has not previously been reported in somatic cancers (COSMIC). Experimental evidence: P.Ala222Val showed approximately 30% homozygous enzyme activity and increased thermolability across expression and patient-fibroblast assays. Based on available guidelines, this variant is considered to be Benign. This variant is considered to be drug response by the VCEP (ClinPGx; ClinVar ID 3520).
Five-step scale from benign to pathogenic. This variant is benign. Select a step to read what it means.
This variantScenario
BenignPathogenic
Benign.A benign classification under the recorded framework.
In plain language
Gene-level background from the recorded interpretation.
Words with a dotted underline have a short definition. Hover or tap them.
About MTHFR
MTHFR encodes an enzyme that helps process folate and supports the conversion of homocysteine into methionine, an essential building block for the body. Changes in this gene can cause methylenetetrahydrofolate reductase deficiency and may influence susceptibility to vascular disease and neural tube defects. MTHFR has been studied in colon cancer, acute leukemia, and other cancers, but there is insufficient evidence to classify it as an oncogene or tumor suppressor.
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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.
Met at supporting: p.Ala222Val showed approximately 30% homozygous enzyme activity and increased thermolability across expression and patient-fibroblast assays.
PP3Moderate
PP3 · moderate
Met at moderate strength: missense REVEL score 0.842 meets the generic PP3 threshold of >=0.773 but is below the >=0.932 strong threshold.
Benign criteria applied · 2
BA1Stand alone
BA1 · stand alone
Met: gnomAD allele frequency is 0.318214, far above the generic BA1 stand-alone threshold of 0.05.
BS1Strong
BS1 · strong
Met: AF 0.318214 with 87,723 homozygotes is far above the generic BS1 default threshold of 0.01 and incompatible with a rare fully penetrant disorder.
Recorded classification: Benign
Benign: BA1 stand-alone is met by the 0.318214 gnomAD allele frequency, with BS1 strong also applied; pathogenic evidence does not satisfy a pathogenic rule.
02The sources
Evidence at a glance
Evidence summaries and captured source records, where available. Missing entries should not be interpreted as negative findings.
gnomAD v4.1
gnomAD v2.1
Population frequency
513,548 / 1,613,846 alleles
gnomAD v4.1: 513,548 / 1,613,846 alleles. Recorded AF 0.318214. Recorded homozygote count 87723.
gnomAD v2.1
This variant is present in gnomAD v2.1 (AF= 0.308483; MAF= 30.84828%, 87234/282784 alleles, homozygotes = 15819) and has highest observed frequency in the Admixed American population (AF= 0.501919; MAF= 50.19187%, 17788/35440 alleles, homozygotes = 4654); grpmax FAF= 0.496463.
gnomAD-Canada
This variant is present in gnomAD-Canada v1.0 (AF= 0.3201935624184428, 5889/18392 alleles, homozygotes = 1086).
OncoKB did not identify variant-specific reviewed functional evidence for this variant; gene-level curated context is available for reviewer follow-up. MTHFR, a reductase in the folate cycle, is altered in various cancers.
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 · 10 not met · 10 not assessed · 4 not applicable. Open any row for the full reasoning, the rule and the evidence behind it.
PS2, PM6, PP1, and BS4 are all not assessed because the available case materials contain no proband-level de novo testing or family-level segregation/non-segregation data for NM_005957.5:c.665C>T.
Functional evidence supports PS3 at supporting strength because concordant biochemical, thermolability, expression, and patient-fibroblast findings indicate impaired MTHFR function, but clinical diagnostic laboratory validation is not established in the supplied evidence.
BS3 is not met because the available studies show reduced activity and thermolability rather than no damaging effect.
No VCEP covers MTHFR, so generic ACMG/AMP 2015 rules govern.
The available paper extracts document common C677T/A222V population, biochemical, functional, or treatment-toxicity observations, but do not establish PP4, BP5, or a qualifying PS4 case-control estimate.
ClinVar's exact-variant expert-panel classification is drug response, so it does not satisfy the required Pathogenic/Likely pathogenic PP5 or Benign/Likely benign BP6 trigger.
Generic ACMG/AMP rules govern because no VCEP covers MTHFR.
The variant is missense, so PP3 and BP4 use the REVEL path only; the available SpliceAI score is not counted for either criterion.
REVEL 0.842 meets PP3 moderate but not PP3 strong, and does not meet BP4 supporting.
Population evidence strongly supports a benign interpretation for this common MTHFR c.665C>T (p.Ala222Val) polymorphism: BA1 is met and BS1 is met, while PM2 is not met.
BS2 was not assessed because the available aggregate population data do not establish healthy-adult status, inheritance model, and early full penetrance as required by the criterion.
No criteria match.
Met · 4
PS3SupportingACMG_2015Met at supporting: p.Ala222Val showed approximately 30% homozygous enzyme activity and increased thermolability across expression and patient-fibroblast assays.
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Reasoning
PS3 is met at supporting strength. Multiple biologically relevant, variant-specific functional studies evaluate MTHFR p.Ala222Val (historical c.677C>T numbering). Frosst et al. demonstrated reduced MTHFR activity in homozygotes, reduced residual activity after heat treatment, and greater thermolability of mutagenized versus wild-type MTHFR expressed in E. coli, with genotype/activity and assay comparisons serving as controls. Subsequent work in patient fibroblast lysates found genotype-dependent thermolability (CC 42 ± 11%, CT 29 ± 14%, TT 21 ± 9% activity remaining after heat treatment), and recombinant MTHFR work identifies approximately 60% activity reduction in homozygotes. The concordant biochemical, stability, and cell-based findings support a damaging effect on protein function. Supporting rather than stronger calibration is appropriate because the supplied evidence does not demonstrate validation, reproducibility, and robustness in a clinical diagnostic laboratory setting.
Rule
Well-established in vitro or in vivo functional studies supportive of a damaging effect on the gene or gene product.
Evidence considered
Frosst et al. 1995 (PMID:7647779), Results/Table 1/Figure 2: the c.677C>T alanine-to-valine variant had approximately 30% of mean MTHFR activity in homozygotes and 65% in heterozygotes; residual activity after heating was 22% in homozygotes, 56% in heterozygotes, and 67% in noncarriers; mutagenized MTHFR cDNA expressed in E. coli was significantly more thermolabile than wild type.
Goyette et al. 2003 (PMID:12673793), Introduction and recombinant-expression sections: c.677C>T (A222V) lies in the catalytic domain and decreases enzyme activity by approximately 60% in homozygotes; the recombinant study used the valine allele as a defined background while testing other mutations.
Watkins et al. 2015 (PMID:25736335), Results, section ‘SNPs and thermolability’: among 42 mutant fibroblast cell lines with detectable activity, heat-treated residual activity was 42 ± 11% for CC, 29 ± 14% for CT, and 21 ± 9% for TT.
Hickey et al. 2016 (PMID:26872964), Introduction: p.Ala222Val is reported to lower MTHFR protein stability and residual enzymatic activity when combined with severe mutations.
Still missing
No supplied evidence demonstrates validation, reproducibility, and robustness of the assay in a clinical diagnostic laboratory setting.
PP3ModerateACMGMet at moderate strength: missense REVEL score 0.842 meets the generic PP3 threshold of >=0.773 but is below the >=0.932 strong threshold.
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Reasoning
NM_005957.5:c.665C>T produces the missense substitution NP_005948.3:p.(Ala222Val). Under the generic rule, the missense path uses REVEL only; SpliceAI is not used for PP3/BP4 in this situation. The REVEL score is 0.842, which meets the supplied generic PP3 moderate threshold of >=0.773 but does not meet the strong threshold of >=0.932. Therefore PP3 is met at moderate strength. BayesDel has no established generic ACMG-strength calibration and is not used.
Rule
Multiple lines of computational evidence support a deleterious effect on the gene or gene product (conservation, evolutionary, splicing impact, etc.)....Missense variant -> REVEL only. Its SpliceAI score says nothing about whether the amino-acid substitution is tolerated, so 'no predicted splice impact' is never BP4 support for a missense variant....PP3 (moderate): >= 0.773 — ClinGen SVI REVEL calibration (Pejaver et al. 2022, Am J Hum Genet) (PMID:36413997)
Evidence considered
Variant consequence: NM_005957.5:c.665C>T is a missense variant, NP_005948.3:p.(Ala222Val), so the applicable generic computational path is REVEL only; SpliceAI is not used for this missense PP3 assessment.
Local REVEL predictor lookup: REVEL score = 0.842.
ClinGen SVI REVEL calibration (Pejaver et al. 2022, Am J Hum Genet; PMID:36413997): generic PP3 moderate threshold >=0.773 and strong threshold >=0.932; 0.842 therefore supports PP3 at moderate strength.
BayesDel score is not used because no generic ACMG-strength calibration is established for BayesDel.
Sources
revel
BA1Stand aloneACMGMet: gnomAD allele frequency is 0.318214, far above the generic BA1 stand-alone threshold of 0.05.
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Reasoning
BA1 is met. The variant is common in both default all-comers gnomAD datasets: AF 0.308483 in gnomAD v2.1 (87,234/282,784 alleles) and AF 0.318214 in gnomAD v4.1 (513,548/1,613,846 alleles). The highest population frequencies are also far above the 5% stand-alone threshold, including 0.501919 in the gnomAD v2.1 Admixed American population and 0.483516 in the gnomAD v4.1 Amish population. The non-cancer subsets are concordant (0.314785 in gnomAD v2.1 non-cancer exomes and 0.274260 in gnomAD v3.1 non-cancer genomes), so cohort selection does not alter the conclusion.
BS1StrongACMGMet: AF 0.318214 with 87,723 homozygotes is far above the generic BS1 default threshold of 0.01 and incompatible with a rare fully penetrant disorder.
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Reasoning
BS1 is met. The variant has AF 0.308483 in gnomAD v2.1 and 0.318214 in gnomAD v4.1, with 15,819 and 87,723 homozygotes, respectively; non-cancer datasets remain similarly high at AF 0.314785 in v2.1 exomes and 0.274260 in v3.1 genomes. These frequencies and homozygote counts are far above what would be expected for a rare, fully penetrant early-onset MTHFR deficiency disorder, even without relying solely on the 1% default. The result is not an ancestry-only elevation: multiple broad populations show high frequencies, including European non-Finnish AF 0.337103 in gnomAD v4.1 and East Asian AF 0.348436.
Rule
BS1 (strong): >= 0.01 — Generic SVI default; per-gene derivation preferred (Whiffin et al. 2017) (PMID:28518168)
Non-cancer concordance: gnomAD v2.1 non-cancer exomes AF=0.314785 with 13,862 homozygotes; gnomAD v3.1 non-cancer genomes AF=0.274260 with 6,696 homozygotes.
The elevated frequency is not confined to one ancestry: gnomAD v4.1 European non-Finnish AF=0.337103 and East Asian AF=0.348436.
The generic 1% BS1 value is a default; the governing prompt directs consideration of maximum credible allele frequency using prevalence, penetrance and allelic heterogeneity, citing Whiffin et al. 2017 (PMID:28518168). The observed frequency and homozygote burden are orders of magnitude above a rare fully penetrant early-onset disorder expectation.
PS1ACMG_2015Not met: no previously established pathogenic variant with the same Ala222Val amino-acid change from a different nucleotide change was identified.
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Reasoning
PS1 is not met. The variant is MTHFR NP_005948.3:p.(Ala222Val), but the reviewed evidence identifies this exact A222V change rather than a different nucleotide change producing the same amino-acid substitution; no previously established pathogenic same-amino-acid variant with an alternate nucleotide change is documented. PMID:12673793 and PMID:7647779 discuss the common 677C>T/A222V polymorphism, not an independent same-protein-change pathogenic comparator.
Rule
Same amino acid change as a previously established pathogenic variant regardless of nucleotide change.
Evidence considered
The normalized variant is NM_005957.5:c.665C>T, NP_005948.3:p.(Ala222Val).
PMID:12673793 explicitly discusses MTHFR 677C>T (A222V); it does not provide a different nucleotide change causing the same Ala222Val substitution established as pathogenic.
PMID:7647779 identifies the common C-to-T substitution converting alanine to valine; it is not an independent same-amino-acid-change pathogenic comparator.
ClinVar lists multiple conflicting submissions for the exact c.665C>T/p.Ala222Val variant, not a separate nucleotide change producing the same amino-acid change.
PM1ACMG_2015Not met: although A222V lies in the catalytic domain, gnomAD v4.1 reports AF 0.318214 with 87,723 homozygotes, demonstrating common benign variation.
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Reasoning
PM1 is not met. PMID:12673793 places A222V within the MTHFR catalytic domain, but the generic PM1 requirement is a critical domain or hotspot without benign variation. This variant itself is common in population databases (gnomAD v4.1 AF 0.318214; 513548/1613846 alleles; 87723 homozygotes), so the required absence of benign variation is not satisfied. vcep_materials.json has no MTHFR domain-table entry and no VCEP-specific hotspot route applies.
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
PMID:12673793, Introduction: "The first, 677C>T (A222V), lies within the catalytic domain and decreases enzyme activity by approximately 60% when present in the homozygous state."
gnomAD v4.1 reports NM_005957.5:c.665C>T/p.Ala222Val at AF 0.318214, with 513548 of 1613846 alleles and 87723 homozygotes.
vcep_materials.json reports no VCEP coverage and an empty domain_tables object for MTHFR.
The case evidence reports no statistically significant hotspot for this residue and no exact variant listing in the hotspot source.
PM2ACMGNot met: gnomAD AF is 0.318214, vastly above the generic PM2 supporting threshold of 0.0001 or less.
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Reasoning
PM2 is not met. The variant is not absent or extremely rare in controls; it occurs at AF 0.308483 in gnomAD v2.1 and AF 0.318214 in gnomAD v4.1, with concordant non-cancer frequencies of 0.314785 in v2.1 exomes and 0.274260 in v3.1 genomes. Each value is vastly above the generic PM2 supporting threshold of <=0.0001.
Rule
PM2 (supporting): <= 0.0001 — SVI recommendation to downgrade PM2 to Supporting (ClinGen SVI 2020) (PMID:25741868)
Published generic calibration: PM2 supporting threshold <=0.0001, attributed in the governing prompt to the ClinGen SVI recommendation and ACMG/AMP 2015 reference (PMID:25741868).
PM5ACMG_2015Not met: no different missense substitution at MTHFR residue Ala222 with an established pathogenic classification was identified.
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Reasoning
PM5 is not met. The observed substitution is Ala222Val, and the reviewed same-residue candidate collection contains no alternate missense change at Ala222 with an established pathogenic classification. The available publications describe A222V itself and do not establish a different pathogenic missense substitution at residue 222.
Rule
Novel missense change at an amino acid residue where a different missense change determined to be pathogenic has been seen before.
Evidence considered
The observed protein change is NP_005948.3:p.(Ala222Val), residue 222.
pm5_candidates.json reports zero same-residue candidates and zero expert-panel or non-expert majority pathogenic/likely pathogenic candidates.
PMID:12673793 and PMID:26872964 discuss the A222V polymorphism itself, not a different missense change at Ala222 established as pathogenic.
PP2ACMG_2015Not met: gnomAD v4.1 shows A222V at AF 0.318214 with 87,723 homozygotes, incompatible with a low rate of benign missense variation.
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Reasoning
PP2 is not met. The criterion requires both a low rate of benign missense variation and missense variants as a common disease mechanism. MTHFR has abundant benign missense variation: the observed A222V variant alone has gnomAD v4.1 AF 0.318214 with 87723 homozygotes, directly contradicting a low benign-missense-rate premise. The available evidence also documents the common A222V polymorphism as a frequent studied variant rather than establishing the required gene-level PP2 combination.
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.
Evidence considered
gnomAD v4.1 reports the missense A222V variant at AF 0.318214, with 513548/1613846 alleles and 87723 homozygotes.
PMID:26872964 describes p.Ala222Val as one of the few common MTHFR variants and as particularly well studied, with effects on protein stability and residual activity.
Because the low-benign-missense-variation requirement is not satisfied, PP2 is not met regardless of the separate disease-mechanism prong.
PP5ACMG_2015Not met: the exact-variant ClinVar expert-panel classification is drug response, not Pathogenic or Likely pathogenic.
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Reasoning
The exact-variant ClinVar expert-panel classification is drug response, not Pathogenic or Likely pathogenic. The Pathogenic and Likely pathogenic records are ordinary laboratory submissions or single-submitter assertions, which do not meet the required expert-panel condition for 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 variation 3520 exact-match record: review status is reviewed by expert panel, but the expert-panel classification is drug response; Pathogenic/Likely pathogenic entries are non-expert submissions and are excluded.
BS3ACMG_2015Not met: functional studies report approximately 30% homozygous activity and 21% heat-treated residual activity, indicating impairment rather than no damaging effect.
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Reasoning
BS3 is not met. The reviewed functional evidence does not show no damaging effect on MTHFR p.Ala222Val; instead, the reported biochemical and cellular assays show reduced enzyme activity and increased thermolability, including approximately 30% activity in homozygotes and 21% residual activity after heat treatment in TT fibroblast lines. No independent well-established assay demonstrating normal protein function or normal splicing for this variant was identified.
Rule
Well-established in vitro or in vivo functional studies show no damaging effect on protein function or splicing.
Evidence considered
Frosst et al. 1995 (PMID:7647779), Results/Table 1/Figure 2: homozygous p.Ala222Val-equivalent c.677C>T carriers had approximately 30% of mean MTHFR activity and 22% residual activity after heating, while wild-type controls had higher activity.
Watkins et al. 2015 (PMID:25736335), Results, section ‘SNPs and thermolability’: TT fibroblast lines retained 21 ± 9% activity after heat treatment versus 42 ± 11% for CC lines.
Still missing
No independent well-established assay showing normal protein function or normal splicing for p.Ala222Val was identified.
BP1ACMG_2015Not met: MTHFR deficiency literature includes multiple missense mutations, so disease is not shown to be caused primarily by truncating variants.
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Reasoning
BP1 is not met. MTHFR is not established here as a gene in which disease is caused primarily by truncating variants: the reviewed MTHFR deficiency literature describes multiple missense disease-associated mutations, while the common A222V missense variant is extensively characterized. Therefore the gene-level primarily-truncating premise of BP1 is not supported.
Rule
Missense variant in a gene for which primarily truncating variants are known to cause disease.
Evidence considered
PMID:10679944 reports characterization of six novel MTHFR mutations in patients with homocystinuria and discusses severe MTHFR deficiency mutations alongside the 677C>T missense polymorphism.
PMID:26872964 reviews severe MTHFR deficiency and identifies p.Ala222Val as a common MTHFR variant; its discussion is not restricted to a primarily truncating disease mechanism.
The available evidence does not establish a primarily truncating MTHFR disease mechanism, so BP1 is not met.
BP4ACMGNot met: missense REVEL score 0.842 exceeds the generic BP4 supporting threshold of <=0.29, so the result is outside the benign range.
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Reasoning
NM_005957.5:c.665C>T is a missense variant, so BP4 must be assessed using REVEL only; the SpliceAI result cannot be substituted into the missense path. REVEL is 0.842, above the generic BP4 supporting threshold of <=0.29 and therefore in neither a BP4 range nor a benign computational range. BP4 is not met. BayesDel has no established generic ACMG-strength calibration and is not used.
Rule
Multiple lines of computational evidence suggest no impact on gene or gene product (conservation, evolutionary, splicing impact, etc.)....Missense variant -> REVEL only. Its SpliceAI score says nothing about whether the amino-acid substitution is tolerated, so 'no predicted splice impact' is never BP4 support for a missense variant....BP4 (supporting): <= 0.29 — ClinGen SVI REVEL calibration (Pejaver et al. 2022, Am J Hum Genet) (PMID:36413997)
Evidence considered
Variant consequence: NM_005957.5:c.665C>T is a missense variant, so the applicable generic computational path is REVEL only; SpliceAI is not evidence for BP4 in this situation.
Local REVEL predictor lookup: REVEL score = 0.842.
ClinGen SVI REVEL calibration (Pejaver et al. 2022, Am J Hum Genet; PMID:36413997): generic BP4 supporting threshold <=0.29; the score 0.842 does not meet BP4.
BayesDel score is not used because no generic ACMG-strength calibration is established for BayesDel.
Sources
revel
BP6ACMG_2015Not met: the exact-variant ClinVar expert-panel classification is drug response, not Benign or Likely benign.
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Reasoning
The exact-variant ClinVar expert-panel classification is drug response rather than Benign or Likely benign. Benign and Likely benign records in ClinVar are ordinary laboratory or non-expert submissions, so they cannot trigger BP6 under the required expert-panel restriction.
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 variation 3520 exact-match record: review status is reviewed by expert panel, but the expert-panel classification is drug response; Benign/Likely benign entries are non-expert submissions and are excluded.
PS2ACMG_2015Not assessed: no proband phenotype, confirmed maternity and paternity, de novo genotype, or family-history information is documented.
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Reasoning
The case materials do not document a proband with a defined disease phenotype, confirmed maternity and paternity, a de novo genotype, or absence of family history for NM_005957.5:c.665C>T. Therefore the PS2 requirements cannot be assessed.
Rule
De novo (both maternity and paternity confirmed) in a patient with the disease and no family history.
Evidence considered
The case materials provide variant normalization and population/literature records but no proband-level parental testing or de novo observation for NM_005957.5:c.665C>T.
The ACMG/AMP framework source was reviewed for the PS2 definition; it supplies no case-specific de novo evidence.
Still missing
Document the proband's disease phenotype and relevant family history.
Obtain parental genotypes and confirmation of both maternity and paternity.
Confirm whether the variant is absent from both biological parents.
PS4ACMG_2015Not assessed: no verifiable exact-variant affected-versus-control counts or odds ratio with a 95% confidence interval are available for the PS4 >5.0 and CI-excluding-1 requirement.
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Reasoning
The reviewed literature includes studies of the common MTHFR C677T/A222V polymorphism and genotype-associated biochemical or treatment-toxicity outcomes, but no accessible source supplies a qualifying affected-disease case count and matched unaffected/population-control count for this exact variant with which to calculate an OR and 95% CI. The literature_pass.json criteria index lists PMID:11710708, PMID:12915598, PMID:20301327, PMID:25394175, PMID:30247353, and PMID:35645034 as PS4 leads, but packet.ai_classified_papers is empty and none of those papers has a paper_extracts entry or available full text in this case, so those leads cannot be verified against an abstract or full text. gnomAD v4 reports a population allele frequency of 0.318214, but a population frequency alone is not a case-control comparison and cannot establish PS4.
Rule
The prevalence of the variant in affected individuals is significantly increased compared to the prevalence in controls. ... 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
literature_pass.json packet.ai_classified_papers is empty; its PS4 criteria index lists PMID:11710708, PMID:12915598, PMID:20301327, PMID:25394175, PMID:30247353, and PMID:35645034 as leads without verifiable paper extracts in this case.
gnomAD v4.1 source data for NM_005957.5:c.665C>T / p.Ala222Val: allele frequency 0.318214 (513548/1613846 alleles); this is population prevalence, not affected-versus-control case-control evidence.
Still missing
Retrieve and verify PMID:11710708, PMID:12915598, PMID:20301327, PMID:25394175, PMID:30247353, and PMID:35645034 against abstracts or full text.
Obtain exact-variant affected and matched control counts, or case frequency and matched-ancestry control frequency, and calculate OR with 95% CI if reported.
PM3ACMG_2015Not assessed: no affected-proband observation identifies a pathogenic partner in trans or provides parental/offspring phase testing.
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Reasoning
PM3 is relevant to the recessive MTHFR deficiency context, but the available evidence does not identify an affected proband carrying NM_005957.5:c.665C>T with a specified pathogenic MTHFR variant, nor does it establish that any such variants are in trans through parental or offspring testing. Population homozygote observations and functional descriptions of p.Ala222Val do not establish the required affected-proband compound-heterozygous phase observation.
Rule
For recessive disorders, detected in trans with a pathogenic variant ... This requires testing of parents (or offspring) to determine phase.
Evidence considered
The available evidence describes common p.Ala222Val functional effects and population homozygotes, but does not document a qualifying affected-proband compound-heterozygous observation with a pathogenic MTHFR allele in trans.
No parental, offspring, or other phase-testing result is provided for this variant with a pathogenic MTHFR partner.
Still missing
Affected-proband data with a specified pathogenic MTHFR variant are needed.
Parental, offspring, or equivalent phasing data are needed to establish trans configuration.
PM6ACMG_2015Not assessed: no affected proband with an assumed de novo variant and documented parental-testing or family-history status is provided.
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Reasoning
The case materials do not document an assumed de novo occurrence of NM_005957.5:c.665C>T in an affected patient, nor do they provide parental testing or a documented absence of family history. Therefore PM6 cannot be assessed.
Rule
Assumed de novo, but without confirmation of paternity and maternity.
Evidence considered
No proband-level case report, parental genotype, or assumed de novo observation for NM_005957.5:c.665C>T is documented in the case materials.
The ACMG/AMP framework source was reviewed for the PM6 definition; it supplies no case-specific de novo evidence.
Still missing
Document the proband's disease phenotype and family history.
Document the variant's presence in the proband and absence or unknown status in each biological parent.
Clarify whether de novo status is assumed from clinical data or family history.
PP1ACMG_2015Not assessed: zero affected relatives, informative meioses, or familial genotype–phenotype segregation observations are documented.
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Reasoning
The case materials contain no affected family members, meioses, familial genotypes, or phenotype-segregation observations for NM_005957.5:c.665C>T. Consequently, co-segregation cannot be assessed.
Rule
Co-segregation with disease in multiple affected family members in a gene definitively known to cause the disease.
Evidence considered
The case materials do not provide a family pedigree, affected-relative testing, unaffected-relative testing, or segregation analysis for NM_005957.5:c.665C>T.
No reviewed publication in the available extracted literature reports family co-segregation for this variant.
Still missing
Identify affected relatives and document their disease phenotypes.
Obtain variant genotypes for affected and unaffected informative relatives.
Document the number of informative meioses and segregation pattern.
PP4ACMG_2015Not assessed: no patient phenotype or family history is documented to evaluate specificity for a single-gene disease.
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Reasoning
The case evidence supplied does not provide an evaluated patient phenotype or family history for this variant. Without a documented phenotype that is highly specific for a disease with a single genetic etiology, PP4 cannot be adjudicated.
Rule
Patient’s phenotype or family history is highly specific for a disease with a single genetic etiology.
Still missing
Provide the patient's phenotype, clinical diagnosis, and relevant family history, including whether the presentation is specific for a single genetic etiology.
BS2ACMG_2015Not assessed: 87,723 homozygotes are reported, but healthy-adult status and early full penetrance are not established.
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Reasoning
BS2 is not assessed. gnomAD documents many homozygotes, but the available population records do not establish that specific individuals were healthy adults, and the case does not document the required inheritance model or that full penetrance is expected at an early age for the disorder being evaluated. Homozygote counts alone therefore cannot satisfy the complete BS2 definition.
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 15,819 homozygotes and gnomAD v4.1 reports 87,723 homozygotes for NM_005957.5:c.665C>T (p.Ala222Val).
The database records provide allele and homozygote counts but do not provide individual-level phenotype, age, or confirmation that each homozygote was a healthy adult.
Still missing
Confirm the disorder and inheritance model, and document that the observed homozygotes were healthy adults with expected early full penetrance.
BS4ACMG_2015Not assessed: no affected relatives with tested negative genotypes or phenotype-reviewed non-segregation observations are documented.
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Reasoning
The case materials do not document affected relatives who lack NM_005957.5:c.665C>T, nor do they provide a family pedigree, phenotype review, or an analysis excluding phenocopies. Lack of segregation therefore cannot be assessed.
Rule
Lack of segregation in affected members of a family.
Evidence considered
No affected-family-member genotype-negative observation or other family non-segregation evidence for NM_005957.5:c.665C>T is documented.
The case materials do not provide the family-level phenotype and genetic information needed to evaluate the BS4 caveat concerning phenocopies or more than one pathogenic variant.
Still missing
Identify affected relatives and document their clinical phenotypes.
Obtain reliable variant genotypes for affected relatives.
Assess phenocopy and multiple-pathogenic-variant explanations before interpreting non-segregation.
BP2ACMG_2015Not assessed: no pathogenic allelic partner is documented with the required cis or trans phase for BP2.
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Reasoning
The evidence does not document NM_005957.5:c.665C>T in trans with a pathogenic variant in a fully penetrant dominant disorder, or in cis with a pathogenic variant in any inheritance pattern. Population homozygote counts and general functional studies do not establish cis/trans phase or a pathogenic allelic partner, so BP2 cannot be assessed.
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 case evidence does not identify a pathogenic allelic partner for this variant or provide molecular phasing showing cis or trans configuration.
Population observations and functional studies do not substitute for the required cis/trans allelic observation.
Still missing
A documented pathogenic allelic partner is needed.
Phasing evidence is needed to establish cis or trans configuration and, for the trans path, a fully penetrant dominant disorder context.
BP5ACMG_2015Not assessed: no case-level alternate molecular diagnosis is documented for a patient carrying this variant.
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Reasoning
The supplied case evidence does not identify a patient with a documented alternate molecular basis for disease in whom this variant was found. The absence of such case-level information prevents adjudication of BP5.
Rule
Variant found in a case with an alternate molecular basis for disease.
Still missing
Provide case-level evidence showing an alternate molecular basis for the patient's disease and confirming that this variant was found in that case.
Not applicable · 4· recorded as not applicableShow reasons ▾Hide reasons ▴PVS1N/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_005957.5:c.665C>T in MTHFR is a missense substitution predicted to produce NP_005948.3:p.(Ala222Val). 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 MTHFR, so the generic ACMG/AMP 2015 definition applies. This determination was made deterministically from the variant's consequence class, prior to LLM adjudication.
PM4N/ANot applicable: PM4 requires a protein-length change, and this is a missense variant.
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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_005957.5:c.665C>T in MTHFR is a missense substitution predicted to produce NP_005948.3:p.(Ala222Val). 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 MTHFR, so the generic ACMG/AMP 2015 definition applies. This determination was made deterministically from the variant's consequence class, prior to LLM adjudication.
BP3N/ANot applicable: BP3 requires an in-frame indel in a repeat region, and this is a missense variant.
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Reasoning
BP3 (Richards et al. 2015, PMID:25741868) applies to in-frame insertions/deletions located in a repetitive region without a known function. NM_005957.5:c.665C>T in MTHFR is a missense substitution predicted to produce NP_005948.3:p.(Ala222Val). 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 MTHFR, so the generic ACMG/AMP 2015 definition applies. This determination was made deterministically from the variant's consequence class, prior to LLM adjudication.
BP7N/ANot applicable: BP7 requires a synonymous variant, and this is a missense variant.
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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_005957.5:c.665C>T in MTHFR is a missense substitution predicted to produce NP_005948.3:p.(Ala222Val). 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 MTHFR, 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
MTHFR
Transcript
NM_005957.5
Coding (HGVS c.)
NM_005957.5:c.665C>T
Protein (HGVS p.)
NP_005948.3:p.(Ala222Val)
GRCh38
chr1:11796321 G>A
GRCh37
chr1:11856378 G>A
Location and type
Exon 5 · missense
ClinVar
3520, 499744
Gene diagram
Every interpreted variant in MTHFR, mapped onto the exon structure of NM_005957.5. Select a row to find it on the plot.
MTHFRNM_005957.5
Fetching transcript structure from UCSC…
Exons
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Transcript span
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Strand
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Variants mapped
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Source
UCSC ncbiRefSeqCurated
All variants in MTHFR—Select a row to find it on the plot; use the link to open its page.
AF 0.32 · 513548 / 1,613,846 alleles · 87723 hom · FAF 0.47
Amish440 / 910
0.48105 hom
Admixed American28657 / 59,984
0.487236 hom
Ashkenazi Jewish13619 / 29,604
0.463147 hom
East Asian15635 / 44,872
0.352955 hom
European (non-Finnish)397733 / 1,179,858
0.3467492 hom
Remaining individuals19200 / 62,494
0.313108 hom
Middle Eastern1584 / 6,062
0.26233 hom
European (Finnish)14919 / 63,990
0.231788 hom
South Asian13560 / 91,086
0.151194 hom
African/African American8201 / 74,986
0.11465 hom
gnomAD v2.1
AF 0.31 · 87234 / 282,784 alleles · 15819 hom · FAF 0.5
Admixed American17788 / 35,440
0.54654 hom
Ashkenazi Jewish4740 / 10,370
0.461089 hom
European (non-Finnish)43635 / 129,108
0.347511 hom
Remaining individuals2325 / 7,220
0.32395 hom
East Asian5790 / 19,944
0.29929 hom
European (Finnish)5799 / 25,116
0.23694 hom
South Asian4443 / 30,616
0.15389 hom
African/African American2714 / 24,970
0.11158 hom
gnomAD-Canada
AF not recorded · ? / ? alleles
Statements
gnomAD v4.1
This variant is present in gnomAD v4.1 (AF= 0.318214; MAF= 31.82138%, 513548/1613846 alleles, homozygotes = 87723) and has highest observed frequency in the Amish population (AF= 0.483516; MAF= 48.35165%, 440/910 alleles, homozygotes = 105); grpmax FAF= 0.473111.
gnomAD v2.1
This variant is present in gnomAD v2.1 (AF= 0.308483; MAF= 30.84828%, 87234/282784 alleles, homozygotes = 15819) and has highest observed frequency in the Admixed American population (AF= 0.501919; MAF= 50.19187%, 17788/35440 alleles, homozygotes = 4654); grpmax FAF= 0.496463.
gnomAD-Canada
This variant is present in gnomAD-Canada v1.0 (AF= 0.3201935624184428, 5889/18392 alleles, homozygotes = 1086).
PP3ModerateACMGMet at moderate strength: missense REVEL score 0.842 meets the generic PP3 threshold of >=0.773 but is below the >=0.932 strong threshold.
Details ▾Hide ▴
Reasoning
NM_005957.5:c.665C>T produces the missense substitution NP_005948.3:p.(Ala222Val). Under the generic rule, the missense path uses REVEL only; SpliceAI is not used for PP3/BP4 in this situation. The REVEL score is 0.842, which meets the supplied generic PP3 moderate threshold of >=0.773 but does not meet the strong threshold of >=0.932. Therefore PP3 is met at moderate strength. BayesDel has no established generic ACMG-strength calibration and is not used.
Rule
Multiple lines of computational evidence support a deleterious effect on the gene or gene product (conservation, evolutionary, splicing impact, etc.)....Missense variant -> REVEL only. Its SpliceAI score says nothing about whether the amino-acid substitution is tolerated, so 'no predicted splice impact' is never BP4 support for a missense variant....PP3 (moderate): >= 0.773 — ClinGen SVI REVEL calibration (Pejaver et al. 2022, Am J Hum Genet) (PMID:36413997)
Evidence considered
Variant consequence: NM_005957.5:c.665C>T is a missense variant, NP_005948.3:p.(Ala222Val), so the applicable generic computational path is REVEL only; SpliceAI is not used for this missense PP3 assessment.
Local REVEL predictor lookup: REVEL score = 0.842.
ClinGen SVI REVEL calibration (Pejaver et al. 2022, Am J Hum Genet; PMID:36413997): generic PP3 moderate threshold >=0.773 and strong threshold >=0.932; 0.842 therefore supports PP3 at moderate strength.
BayesDel score is not used because no generic ACMG-strength calibration is established for BayesDel.
Sources
revel
BP4ACMGNot met: missense REVEL score 0.842 exceeds the generic BP4 supporting threshold of <=0.29, so the result is outside the benign range.
Details ▾Hide ▴
Reasoning
NM_005957.5:c.665C>T is a missense variant, so BP4 must be assessed using REVEL only; the SpliceAI result cannot be substituted into the missense path. REVEL is 0.842, above the generic BP4 supporting threshold of <=0.29 and therefore in neither a BP4 range nor a benign computational range. BP4 is not met. BayesDel has no established generic ACMG-strength calibration and is not used.
Rule
Multiple lines of computational evidence suggest no impact on gene or gene product (conservation, evolutionary, splicing impact, etc.)....Missense variant -> REVEL only. Its SpliceAI score says nothing about whether the amino-acid substitution is tolerated, so 'no predicted splice impact' is never BP4 support for a missense variant....BP4 (supporting): <= 0.29 — ClinGen SVI REVEL calibration (Pejaver et al. 2022, Am J Hum Genet) (PMID:36413997)
Evidence considered
Variant consequence: NM_005957.5:c.665C>T is a missense variant, so the applicable generic computational path is REVEL only; SpliceAI is not evidence for BP4 in this situation.
Local REVEL predictor lookup: REVEL score = 0.842.
ClinGen SVI REVEL calibration (Pejaver et al. 2022, Am J Hum Genet; PMID:36413997): generic BP4 supporting threshold <=0.29; the score 0.842 does not meet BP4.
BayesDel score is not used because no generic ACMG-strength calibration is established for BayesDel.
Sources
revel
BP7N/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_005957.5:c.665C>T in MTHFR is a missense substitution predicted to produce NP_005948.3:p.(Ala222Val). 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 MTHFR, 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 no significant splice impact for this variant (max delta score = 0.00). REVEL score = 0.842. BayesDel score = 0.547323.
9 paper records listed. 4 cited in the classification.
Cited in the classification
Characterization of mutations in severe methylenetetrahydrofolate reductase deficiency reveals an FAD-responsive mutation.
The paper explicitly identifies the MTHFR common variant 677C>T (A222V), corresponding to the specified A222V variant, places it in the catalytic domain, and reports approximately 60% lower enzyme activity in homozygotes; it does not establish an alternate pathogenic missense at residue 222.
The first, 677C>T (A222V), lies within the catalytic domain and decreases enzyme activity by approximately 60% when present in the homozygous state.
Location Introduction, paragraph discussing the two common MTHFR polymorphisms
Context The paper summarizes prior functional studies of the common 677C>T variant and uses recombinant human MTHFR bacterial-expression constructs carrying the 677T/valine allele as background for testing other mutations.
Insights into severe 5,10-methylenetetrahydrofolate reductase deficiency: molecular genetic and enzymatic characterization of 76 patients.
The paper describes the corresponding MTHFR Ala222Val polymorphism under historical c.677C>T numbering. In 42 mutant fibroblast cell lines with detectable activity, heat-treated residual activity was 42 ± 11% for CC, 29 ± 14% for CT, and 21 ± 9% for TT, demonstrating genotype-dependent thermolability.
Following heat treatment of those mutant cells with detectable MTHFR activity (42 cell lines), those with the CC genotype had 42 ± 11% activity remaining compared to parallel cell lysates without heat treatment, those with CT had 29 ± 14% activity remaining, and TT had 21 ± 9%.
Location Results, section ‘SNPs and thermolability’
Context Genotyping of 76 mutant MTHFR cell lines; heat-treatment thermolability assay performed on 42 mutant cell lines with detectable MTHFR activity; activity measured in cultured patient fibroblast lysates.
Mutation Update and Review of Severe Methylenetetrahydrofolate Reductase Deficiency.
The paper identifies p.Ala222Val as a common, extensively studied MTHFR variant and reports effects on protein stability and residual enzymatic activity when combined with severe mutations; it does not establish a different pathogenic missense at Ala222 or a primarily truncating-only disease mechanism.
Of the few common variants, p.Ala222Val has been particularly well studied, and the effect of this variation in lowering protein stability [Frosst, et al., 1995] and residual enzymatic activity when found in combination with severe mutations [Sibani, et al., 2003] needs to be borne in mind.
Location Introduction, paragraph following the description of the MTHFR gene and transcript isoforms
Context Review article summarizing prior studies of common and severe MTHFR variants, including protein stability and residual enzymatic activity observations.
A candidate genetic risk factor for vascular disease: a common mutation in methylenetetrahydrofolate reductase.
The paper identifies the common C-to-T MTHFR substitution that converts alanine to valine and reports high population frequency and reduced enzyme activity in homozygotes; it does not establish a distinct pathogenic same-amino-acid comparator.
Context Genotyping and MTHFR enzyme activity, thermolability, and plasma homocysteine measurements in 40 individuals; allele-frequency analysis in 114 unselected French Canadian chromosomes; mutagenized versus wild-type MTHFR cDNA expression in E. coli with heat-treatment assay.
Other recorded publications
Pharmacogenetics of methotrexate: toxicity among marrow transplantation patients varies with the methylenetetrahydrofolate reductase C677T polymorphism.
Preponderance of methylenetetrahydrofolate reductase C677T homozygosity among leukemia patients intolerant to methotrexate.
This paper compares MTHFR C677T genotypes among acute-leukemia patients according to methotrexate intolerance and reports genotype-specific toxicity frequencies, but it is not a comparison of variant prevalence in affected individuals versus unaffected controls for a disease caused by MTHFR.
Methotrexate intolerance was encountered in seven of 21 CC patients (33.3%), in six out of 25 CT patients (24%) and in nine of 15 TT patients (60%) (P = 0.03, Fisher's exact test).
Results, page 1917; Table 2
Standards and guidelines for the interpretation of sequence variants: a joint consensus recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology.
This paper provides general ACMG/AMP standards for variant interpretation and discusses evidence categories including segregation, case observations, and family data; it contains no MTHFR c.665C>T-specific de novo or segregation findings.
The variant classification approach described in this paper is meant to be applicable to variants in all Mendelian genes whether identified by single gene tests, multi-gene panels, exome sequencing or genome sequencing.
Introduction, final paragraph
Characterization of six novel mutations in the methylenetetrahydrofolate reductase (MTHFR) gene in patients with homocystinuria.
Sibani S et al. · 2000
The paper characterizes severe MTHFR deficiency mutations in patients with homocystinuria and discusses the common 677C>T alanine-to-valine missense polymorphism; it does not establish a primarily truncating-only mechanism.
The first, 677C→T, changes an evolutionarily conserved alanine into a valine residue, resulting in a thermolabile enzyme which can be stabilized by folate and FAD.
Introduction, page 281; Discussion, pages 285–286
The UK NEQAS for Molecular Genetics scheme for gastrointestinal stromal tumour: findings and recommendations following four rounds of circulation.
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= 0.318214; MAF= 31.82138%, 513548/1613846 alleles, homozygotes = 87723) and has highest observed frequency in the Amish population (AF= 0.483516; MAF= 48.35165%, 440/910 alleles, homozygotes = 105); grpmax FAF= 0.473111.
gnomAD v2.1
This variant is present in gnomAD v2.1 (AF= 0.308483; MAF= 30.84828%, 87234/282784 alleles, homozygotes = 15819) and has highest observed frequency in the Admixed American population (AF= 0.501919; MAF= 50.19187%, 17788/35440 alleles, homozygotes = 4654); grpmax FAF= 0.496463.
gnomAD-Canada
This variant is present in gnomAD-Canada v1.0 (AF= 0.3201935624184428, 5889/18392 alleles, homozygotes = 1086).
ClinVar
This variant has been reported in ClinVar as Benign (8 clinical laboratories) and as Pathogenic (3 clinical laboratories) and as Uncertain significance (3 clinical laboratories) and as Likely benign (1 clinical laboratory) and as Association (1 clinical laboratory) and as other (1 clinical laboratory) and as Likely Pathogenic (1 clinical laboratory) and as drug response by ClinPGx (expert panel). (ClinVarID = 3520)
In silico
SpliceAI predicts no significant splice impact for this variant (max delta score = 0.00). REVEL score = 0.842. BayesDel score = 0.547323.
Functional
OncoKB did not identify variant-specific reviewed functional evidence for this variant; gene-level curated context is available for reviewer follow-up. MTHFR, a reductase in the folate cycle, is altered in various cancers.
Somatic
This variant does not lie in a statistically significant hotspot. This variant has not previously been reported in somatic cancers (COSMIC).
Cancer Hotspots
This variant does not lie in a statistically significant hotspot.