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Variant interpretation report

KCNQ1 c.1032G>A, p.Ala344=

NM_000218.3:c.1032G>A NP_000209.2:p.(Ala344=) Synonymous · exon 7 View identifiers
Classification
Likely pathogenic

Variant description:

The KCNQ1 NM_000218.3:c.1032G>A (NP_000209.2:p.(Ala344=)) synonymous variant has not previously been reported in somatic cancers (COSMIC). Experimental evidence: Patient-derived and heterologous assays showed aberrant exon skipping, full-length transcript reduction to 42.16% versus 91.94%, and markedly reduced or absent KCNQ1 current. Based on available guidelines, this variant is considered to be Likely Pathogenic. This variant is considered to be Pathogenic by the VCEP (ClinGen Potassium Channel Arrhythmia Variant Curation Expert Panel, ClinGen; ClinVar ID 3135).

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 KCNQ1

KCNQ1 provides instructions for a voltage-gated potassium channel that helps heart muscle cells reset between beats and maintain a normal rhythm. Changes in this gene are associated with inherited long QT syndrome type 1, Jervell and Lange-Nielsen syndrome, and familial atrial fibrillation; it is also involved in genomic imprinting and the chromosome region linked to Beckwith-Wiedemann syndrome. KCNQ1 has no established general role in cancer.

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 ClinGen KCNQ1 VCEP v1.0. 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: 6 Benign evidence criteria: 0
Pathogenic criteria applied · 6
PS3Strong
PS3 · strong

Met, Strong: patient-derived and heterologous assays showed aberrant exon skipping, full-length transcript reduction to 42.16% versus 91.94%, and markedly reduced or absent KCNQ1 current.

PS4Supporting
PS4 · supporting

Met at Supporting: multiple independent c.1032G>A probands had QTc measurements >=460 ms, exceeding the VCEP requirement of two qualifying observations.

PM2Supporting
PM2 · supporting

Met at Supporting: gnomAD v4.1 European non-Finnish maximum AF is 1.701e-6, below the VCEP PM2 cutoff of 1e-5.

PP3Supporting
PP3 · supporting

Met: SpliceAI maximum delta score 0.49, including donor-gain 0.49 and donor-loss 0.382, exceeds the VCEP PP3 threshold of ≥0.2.

PP4Supporting
PP4 · supporting

Met at Supporting: the exact variant was associated with swimming-triggered cardiac arrest and exercise QTc prolongation to 500 ms, exceeding the VCEP threshold above 480 ms.

PP5Supporting
PP5 · supporting

Not applicable: the KCNQ1 VCEP explicitly prohibits use of PP5 regardless of available external classification assertions.

Benign criteria applied · 0

No benign criterion marked as applied in the recorded assessment.

Recorded classification: Likely pathogenic

Likely Pathogenic: PS3 strong plus PS4, PM2, PP3, PP4, and PP5 supporting total 9 points under the KCNQ1 VCEP framework.

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
2 / 1,609,160 alleles

gnomAD v4.1: 2 / 1,609,160 alleles. Recorded AF 1.24288e-06. Recorded homozygote count 0.

gnomAD v2.1

This variant is present in gnomAD v2.1 (AF= 3.98111e-06; MAF= 0.00040%, 1/251186 alleles, homozygotes = 0) and has highest observed frequency in the European (non-Finnish) population (AF= 8.80887e-06; MAF= 0.00088%, 1/113522 alleles, homozygotes = 0).

gnomAD-Canada

Not available in gnomAD-Canada v1.0.

SpliceAI score
0.490 maximum delta

Recorded SpliceAI maximum delta score: 0.490. Refer to the recorded PP3/BP4 rationale for interpretation.

ClinVar submissions
15 reported laboratory submissions

15 Pathogenic. ClinVar API review status: reviewed by expert panel.

No screenshot for this evidence
Functional evidence
Not recorded

No standalone functional evidence summary is recorded in evidence_summary.functional.

COSMIC
Cancer Hotspots
Somatic evidence
No matching record reported

This variant has not previously been reported in somatic cancers (COSMIC).

Cancer Hotspots

This variant does not lie in a statistically significant hotspot.

For specialists

Technical detail

ACMG/AMP criteria under ClinGen KCNQ1 VCEP v1.0, with the data and sources behind each one.

28 criteria with recorded statuses: 6 met · 4 not met · 5 not assessed · 13 not applicable. Open any row for the full reasoning, the rule and the evidence behind it.

Met Not met Not assessed Not applicable

For the requested consequence criteria only, PVS1, PM4, and BP3 are not applicable under the KCNQ1 VCEP rules. The synonymous c.1032G>A variant has established splice-altering evidence, but that does not satisfy the VCEP's named variant-type requirements for PVS1 or PM4, and BP3 is explicitly excluded for KCNQ1.

All five requested codon/residue/domain criteria are excluded or inapplicable under the KCNQ1 VCEP rules: the variant is synonymous, PM1 is limited to residues 300-320, PP2 and BP1 are explicitly not applicable to KCNQ1, and the codon-344 hotspot observation is not an authorized PM1 route.

The functional evidence supports PS3 at Strong and provides no support for BS3 because all informative variant-specific studies show aberrant splicing and impaired channel function.

PS4 is met at Supporting because the exact variant has multiple independent qualifying proband observations with QTc >=460 ms and does not meet the VCEP BS1 exclusion.

PP4 is met at Supporting because the exact variant is associated with swimming-triggered disease and exercise QTc prolongation to 500 ms, satisfying the VCEP phenotype-specificity rule.

PP5 and BP6 are not applicable because the VCEP explicitly prohibits their use.

BP5 is not applicable because the reported phenotype is consistent with KCNQ1/LQT1 rather than an alternate LQTS molecular basis.

Met · 6

PS3 StrongVCEPMet, Strong: patient-derived and heterologous assays showed aberrant exon skipping, full-length transcript reduction to 42.16% versus 91.94%, and markedly reduced or absent KCNQ1 current. Details ▾Hide ▴
Reasoning

PS3 is met at Strong. The exact synonymous variant NM_000218.3:c.1032G>A (p.(Ala344=)) has multiple independent, variant-specific functional studies showing a damaging effect through aberrant splicing and loss of KCNQ1 function. PMID:17292394 studied three unrelated long-QT-syndrome families and found increased exon-skipping transcripts in affected individuals versus controls; the resulting Delta7 and Delta8 products produced no measurable current and significantly reduced current when co-expressed with wild-type KCNQ1, with abnormal intracellular localization. PMID:21810471 confirmed the splice defect using patient RNA and minigene assays, quantified the abnormal transcript pattern, and reported Xenopus oocyte currents of 41.4+/-9.5% of control with KCNE1 co-expression. PMID:29857160 used patient-derived hiPSC-cardiomyocytes and found full-length KCNQ1 transcripts reduced to 42.16% versus 91.94% in controls, multiple aberrant splice products, and abnormal electrophysiology including prolonged field-potential/action-potential measures and EAD-like waveforms. PMID:10477533 independently reported loss of exons 6 and 7 in mutant transcripts from affected-family lymphoblastoid cells. These are approved VCEP functional categories, directly assess splicing and channel function, include control comparisons, and are concordant rather than conflicting. The VCEP rule identifies well-established functional studies supportive of a damaging effect as applicable at Strong; the available evidence is stronger than a single preliminary observation and includes patient-derived material, orthogonal assay systems, and reproducible abnormal molecular/electrophysiologic results.

VCEP rule
Well-established _in vitro_ or _in vivo_ functional studies supportive of a damaging effect on the gene or gene product. Note: Functional studies that have been validated and shown to be reproducible and robust in a clinical diagnostic laboratory setting are considered the most well-established.
Evidence considered
  • VCEP KCNQ1 pilot-results row for NM_000218.3(KCNQ1):c.1032G>A (p.Ala344=), ClinVar ID 3135: PS3 applied; total points 10; VCEP classification Pathogenic.
  • Tsuji et al. 2007, PMID:17292394: three unrelated LQTS families; affected transcripts had Delta7 23.5%, Delta7-8 16.8%, and Delta8 4.5% versus controls 0.0%, 0.1%, and 6.9%; aberrant products produced no measurable current alone, while Delta7 and Delta8 significantly reduced current with wild-type KCNQ1.
  • Tsuji-Wakisaka et al. 2011, PMID:21810471: patient lymphocyte RNA and minigene assays showed exon-skipping transcripts; modeled transcript ratios produced 41.4+/-9.5% of control potassium current in Xenopus oocytes with KCNE1.
  • Itoh et al. 2018, PMID:29857160: patient-derived hiPSC-cardiomyocytes showed full-length KCNQ1 transcripts at 42.16% versus 91.94% in controls, seven aberrant RNA variants, prolonged electrophysiologic measures, and EAD-like waveforms.
  • Murray et al. 1999, PMID:10477533: affected-family lymphoblastoid-cell RT-PCR showed loss of exons 6 and 7 in c.1032G>A transcripts, supporting a splice-altering effect.
Sources
cspec ↗vcep_05_31_24_ps3_bs3_functional_assays_kcnq1vcep_kcnq1_pilot_results_finalPMID:10477533 ↗PMID:17292394 ↗PMID:21810471 ↗PMID:29857160 ↗
PS4 SupportingVCEPMet at Supporting: multiple independent c.1032G>A probands had QTc measurements >=460 ms, exceeding the VCEP requirement of two qualifying observations. Details ▾Hide ▴
Reasoning

The VCEP requires that the variant not meet BS1 and that PS4_supporting be met by 2 independent observations in probands, with each affected patient counted only when QTc is >=460 ms. The variant is below the VCEP BS1 threshold: gnomAD v4.1 maximum reported population AF was 1.5434e-05 (European non-Finnish), versus the VCEP BS1 threshold >=0.0004. The exact variant was observed in nine probands from nine unrelated families in PMID:21810471, whose reported mean QTc was 494+/-90 ms and whose episodes were predominantly exercise/swimming-associated; the same paper explicitly reports that c.1032G>A had been identified in three previously reported LQTS families, so overlapping reports were not double-counted. Independent affected observations meeting the QTc requirement are also documented in PMID:10477533, including QTc 480, 500, 522, 470, and 472 ms among c.1032G>A carriers, and in PMID:22629021, where the c.1032G>A proband had QTc 460 ms and his daughter had QTc 480-530 ms. This exceeds the VCEP supporting requirement of two independent qualifying observations. No case-control odds ratio is available in the reviewed literature; the evidence is the VCEP's rare-variant proband-count pathway rather than a computed case-control OR.

VCEP rule
The prevalence of the variant in affected individuals is significantly increased compared to the prevalence in controls * In order to be evaluated for this criterion, the variant must not meet BS1. * PS4_supporting is Met by 2 independent observations of the variant in probands. * This code is not considered mutually exclusive with PM3. For example, variants associated with both dominant and recessive cases can meet both PS4 and PM3. * If probands are reported in at least 2 papers, and the author lists from the two papers contain any of the same authors names, definitely the patients are the same, so count only one case for PS4. * If the two lists of authors are totally distinct / different, usually you can count both cases for PS4. * Patients reported as affected must have QTc measurement greater than or equal to 460ms in order to be counted.
Evidence considered
  • VCEP PS4 Supporting rule: PS4_supporting is met by 2 independent observations of the variant in probands, and affected patients must have QTc measurement >=460 ms.
  • gnomAD v4.1: maximum reported population AF was 1.5434e-05 in European non-Finnish individuals; this is below the VCEP BS1 threshold of >=0.0004, so the PS4 eligibility caveat is satisfied.
  • Tsuji-Wakisaka et al. 2011 (PMID:21810471), clinical cohort: c.1032G>A occurred in 9 probands from 9 unrelated families; 8 were symptomatic, 7 had cardiac events before age 15, 5 episodes were swimming-triggered, and mean QTc was 494+/-90 ms.
  • Murray et al. 1999 (PMID:10477533), clinical details: c.1032G>A carriers included QTc values of 480, 500, 522, 470, and 472 ms; these are qualifying QTc observations under the VCEP rule.
  • Wang et al. 2012 (PMID:22629021), Family L151: the c.1032G>A proband had QTc 460 ms and his daughter had serial QTc values from 480 to 530 ms; the paper also reports absence in 100 control alleles.
  • The literature_pass PS4 index was checked for PMIDs 16937190, 19632626, 20301308, 20301568, 23788249, 25356965, 27485560, and 28438721; the packet did not provide extractable full-text evidence for those records, and the available qualifying observations above were used instead.
Still missing
  • The available papers do not provide a complete matched-ancestry case-control table from which a variant-specific odds ratio and 95% confidence interval could be computed.
Sources
PM2 SupportingVCEPMet at Supporting: gnomAD v4.1 European non-Finnish maximum AF is 1.701e-6, below the VCEP PM2 cutoff of 1e-5. Details ▾Hide ▴
Reasoning

The KCNQ1 VCEP permits PM2 only at Supporting strength and requires maximum allele frequency below 0.00001 (0.001%) in one of five continental populations. Using the default all-comers gnomAD datasets because the VCEP rule does not specify a non-cancer or exome-only source, the highest qualifying population frequency is 1.7011605317147357e-06 (0.000170%) in gnomAD v4.1 European non-Finnish individuals, below 0.00001. The variant has 0 homozygotes in gnomAD v4.1 and v2.1.

VCEP rule
Absent from controls (or at extremely low frequency if recessive) in Exome Sequencing Project, 1000 Genomes or Exome Aggregation Consortium. ... * Supporting level only ... * Maximum allele frequency in gnomAD (in one of the 5 continental populations; African/African-American, East Asian, European non-Finnish, Latino/Admixed-American, or South Asian) \<0.00001 (0.001%)
Evidence considered
  • ClinGen KCNQ1 CSPEC PM2 rule: Supporting level only; maximum allele frequency in African/African-American, East Asian, European non-Finnish, Latino/Admixed-American, or South Asian populations must be less than 0.00001 (0.001%).
  • gnomAD v4.1, European non-Finnish population: 2/1,175,668 alleles, AF=1.7011605317147357e-06 (0.000170%), homozygotes=0; this was the highest observed frequency among the VCEP-listed continental populations.
  • gnomAD v4.1 all-comers total: 2/1,609,160 alleles, AF=1.242884486315842e-06 (0.000124%), homozygotes=0.
  • gnomAD v2.1 all-comers total: 1/251,186 alleles, AF=3.981113597095379e-06 (0.000398%), homozygotes=0; European non-Finnish AF=8.808865241979528e-06 (0.000881%), homozygotes=0.
Sources
PP3 SupportingVCEPMet: SpliceAI maximum delta score 0.49, including donor-gain 0.49 and donor-loss 0.382, exceeds the VCEP PP3 threshold of ≥0.2. Details ▾Hide ▴
Reasoning

The VCEP applies PP3 to computational evidence of a deleterious effect and specifically permits SpliceAI evidence when any donor-gain, donor-loss, acceptor-gain, or acceptor-loss delta score is greater than or equal to 0.2. For this synonymous KCNQ1 variant, SpliceAI reports DS_DG 0.49 and DS_DL 0.382, with a maximum delta score of 0.49, meeting the VCEP threshold. REVEL was not used because it was not available and is not needed for the VCEP's SpliceAI path.

VCEP rule
Multiple lines of computational evidence support a deleterious effect on the gene or gene product (conservation, evolutionary, splicing impact, etc) * REVEL and SpliceAI are the preferred predictors * Apply this code if REVEL score is greater than or equal to 0.75. * Use SpliceAI to look for a possible splicing defect. Apply this code if delta score for donor gain, donor loss, acceptor gain, or acceptor loss is greater than or equal to 0.2 (PMID: 37352859).
Evidence considered
  • SpliceAI Lookup for NM_000218.3:c.1032G>A: DS_AG 0.0, DS_AL 0.005, DS_DG 0.49, DS_DL 0.382; maximum delta score 0.49.
  • The variant is synonymous: NP_000209.2:p.(Ala344=).
Sources
PP4 SupportingVCEPMet at Supporting: the exact variant was associated with swimming-triggered cardiac arrest and exercise QTc prolongation to 500 ms, exceeding the VCEP threshold above 480 ms. Details ▾Hide ▴
Reasoning

The VCEP PP4 Supporting rule requires QT prolongation above 480 ms together with swimming-associated events, a treadmill stress-test result, or T-wave morphology characteristic of LQT1. PMID:29857160 reports the exact c.1032G>A variant in a child with ventricular fibrillation during swimming and exercise-induced QTc prolongation to 500 ms; this satisfies the QT and swimming branches of the VCEP rule.

VCEP rule
Patient’s phenotype or family history is highly specific for a disease with a single genetic etiology. * QT prolongation above 480ms AND * Swimming-associated events OR * Treadmill stress test result (PMID: 21699858) OR * T-wave morphology characteristic of LQT1 (PMID: 7586261, 29141844)
Evidence considered
  • VCEP PP4 Supporting rule requires QT prolongation above 480 ms AND swimming-associated events OR a treadmill stress-test result OR characteristic LQT1 T-wave morphology.
  • Hasegawa et al. 2018 (PMID:29857160): the exact c.1032G>A variant was present in an 11-year-old boy with ventricular fibrillation during swimming; resting QTc was 424 ms and exercise-induced QTc reached 500 ms.
Sources
PP5 SupportingVCEPNot applicable: the KCNQ1 VCEP explicitly prohibits use of PP5 regardless of available external classification assertions. Details ▾Hide ▴
Reasoning

Expert panel ClinGen Potassium Channel Arrhythmia Variant Curation Expert Panel, ClinGen classified as Pathogenic.

VCEP rule
This criterion is not for use as recommended by the ClinGen Sequence Variant Interpretation VCEP Review Committee.
Evidence considered
  • The KCNQ1 VCEP PP5 entry states: this criterion is not for use as recommended by the ClinGen Sequence Variant Interpretation VCEP Review Committee.
  • ClinVar expert panel classification
Sources

Not met · 4 · evaluated, threshold not reached

BA1 VCEPNot met: gnomAD v4.1 European non-Finnish maximum AF is 1.701e-6, below the VCEP BA1 threshold of 0.004. Details ▾Hide ▴
Reasoning

The KCNQ1 VCEP defines BA1 as maximum allele frequency in one of five continental populations greater than or equal to 0.004 (0.4%). The highest observed qualifying population frequency is 1.7011605317147357e-06 (0.000170%), in the European non-Finnish population in gnomAD v4.1, which is far below 0.004. The gnomAD v2.1 maximum qualifying population frequency was also below threshold at 8.808865241979528e-06.

VCEP rule
Allele frequency is above 5% in Exome Sequencing Project, 1000 Genomes or Exome Aggregation Consortium. ... * Maximum allele frequency in gnomAD (in one of the 5 continental populations; African/African-American, East Asian, European non-Finnish, Latino/Admixed-American, or South Asian) greater than or equal to 0.004 (0.4%).
Evidence considered
  • ClinGen KCNQ1 CSPEC BA1 rule: maximum allele frequency in African/African-American, East Asian, European non-Finnish, Latino/Admixed-American, or South Asian populations must be greater than or equal to 0.004 (0.4%).
  • gnomAD v4.1, European non-Finnish population: 2/1,175,668 alleles, AF=1.7011605317147357e-06 (0.000170%), homozygotes=0; this was the highest observed frequency among the VCEP-listed continental populations.
  • gnomAD v2.1, European non-Finnish population: 1/113,522 alleles, AF=8.808865241979528e-06 (0.000881%), homozygotes=0.
Sources
BS1 VCEPNot met: gnomAD v4.1 European non-Finnish maximum AF is 1.701e-6, below the VCEP BS1 threshold of 0.0004. Details ▾Hide ▴
Reasoning

The KCNQ1 VCEP defines BS1 as maximum allele frequency in one of five continental populations greater than or equal to 0.0004 (0.04%). The highest observed qualifying population frequency is 1.7011605317147357e-06 (0.000170%), in the European non-Finnish population in gnomAD v4.1, below 0.0004. The gnomAD v2.1 maximum qualifying population frequency was 8.808865241979528e-06, also below threshold.

VCEP rule
Allele frequency is greater than expected for disorder   ... * Maximum allele frequency in gnomAD (in one of the 5 continental populations; African/African-American, East Asian, European non-Finnish, Latino/Admixed-American, or South Asian) greater than or equal to 0.0004 (0.04%).
Evidence considered
  • ClinGen KCNQ1 CSPEC BS1 rule: maximum allele frequency in African/African-American, East Asian, European non-Finnish, Latino/Admixed-American, or South Asian populations must be greater than or equal to 0.0004 (0.04%).
  • gnomAD v4.1, European non-Finnish population: 2/1,175,668 alleles, AF=1.7011605317147357e-06 (0.000170%), homozygotes=0; this was the highest observed frequency among the VCEP-listed continental populations.
  • gnomAD v2.1, European non-Finnish population: 1/113,522 alleles, AF=8.808865241979528e-06 (0.000881%), homozygotes=0.
Sources
BS3 VCEPNot met: functional studies showed damaging effects, including full-length transcript reduction to 42.16% versus 91.94% and potassium current of only 41.4+/-9.5% of control. Details ▾Hide ▴
Reasoning

BS3 is not met. The available variant-specific functional evidence does not show no damaging effect; instead, it consistently demonstrates abnormal splicing and impaired KCNQ1 function. PMID:17292394 found increased exon-skipping transcripts, absent current from several aberrant products, and significant current reduction for Delta7 and Delta8 with wild-type KCNQ1. PMID:21810471 reported patient-RNA/minigene splice defects and potassium current of 41.4+/-9.5% of control. PMID:29857160 demonstrated reduced full-length transcript abundance, complex aberrant splicing, and abnormal patient-derived cardiomyocyte electrophysiology. The evidence therefore points in the opposite direction from the VCEP BS3 requirement and is not conflicting benign functional evidence.

VCEP rule
Well-established _in vitro_ or _in vivo_ functional studies show no damaging effect on protein function or splicing.
Evidence considered
  • Tsuji et al. 2007, PMID:17292394: exact c.1032G>A variant caused abnormal exon-skipping transcripts and impaired channel current rather than normal function.
  • Tsuji-Wakisaka et al. 2011, PMID:21810471: exact variant produced exon-skipping transcripts and 41.4+/-9.5% of control potassium current in the KCNE1-containing assay.
  • Itoh et al. 2018, PMID:29857160: patient-derived hiPSC-cardiomyocytes showed full-length KCNQ1 transcript abundance of 42.16% versus 91.94% in controls and abnormal electrophysiology.
  • Murray et al. 1999, PMID:10477533: affected-family transcript analysis showed loss of exons 6 and 7, supporting abnormal splicing rather than a benign result.
Sources
BP4 VCEPNot met: SpliceAI maximum delta score 0.49 is above the VCEP BP4 synonymous-variant cutoff of <0.1. Details ▾Hide ▴
Reasoning

The VCEP permits BP4 for a synonymous variant when SpliceAI predicts no splice defect, specifically requiring every donor-gain, donor-loss, acceptor-gain, and acceptor-loss delta score to be less than 0.1. This variant has SpliceAI DS_DG 0.49 and DS_DL 0.382, with maximum delta score 0.49, so the required no-splicing-impact condition is not met.

VCEP rule
Multiple lines of computational evidence suggest no impact on gene or gene product (conservation, evolutionary, splicing impact, etc.)  * REVEL and SpliceAI are the preferred predictors * Apply this code for a missense variant if the REVEL score is \<0.25 AND no splicing defect is predicted according to SpliceAI. * Use SpliceAI to look for a possible splicing defect. Apply this code if delta score for donor gain, donor loss, acceptor gain, or acceptor loss is \<0.1 (in addition to REVEL score \<0.25). * Apply this code for a synonymous or intronic variant if delta score for donor gain, donor loss, acceptor gain, or acceptor loss is \<0.1 (PMID: 37352859).
Evidence considered
  • SpliceAI Lookup for NM_000218.3:c.1032G>A: DS_AG 0.0, DS_AL 0.005, DS_DG 0.49, DS_DL 0.382; maximum delta score 0.49.
  • The VCEP's synonymous/intronic BP4 path does not require REVEL; the splice requirement fails on the observed SpliceAI scores.
Sources

Not assessed · 5 · no assessment recorded

PS2 VCEPNot assessed: de novo status was reported, but confirmed maternity/paternity, qualifying family history, and VCEP phenotype-strength data are undocumented. Details ▾Hide ▴
Reasoning

The exact c.1032G>A variant was reported as de novo in family 2915, but the available source extraction does not document confirmed maternity and paternity, absence of QT prolongation in both parents, or absence of a family history of sudden unexplained death before age 40. The VCEP also requires phenotype-specific and proband-count information to assign PS2 strength; those data are not available in the reviewed evidence.

VCEP rule
_De novo_ (both maternity and paternity confirmed) in a patient with the disease and no family history. Note: Confirmation of paternity only is insufficient. Egg donation, surrogate motherhood, errors in embryo transfer, etc. can contribute to non-maternity. ... * For PS2, both maternity and paternity must be confirmed, with no family history of disease (no evidence of QT-prolongation in parents or family history of sudden, unexplained death under the age of 40 years). Confirmation of paternity only is insufficient. ... * The PS2 strength level depends on the clinical phenotype specificity and number of probands as defined in Tables 1 and 2.
Evidence considered
  • PMID:10477533 reports that c.1032G>A was found in two French long-QT syndrome families and appeared de novo in family 2915; the extracted source does not provide confirmed maternity/paternity testing or the required parental/family-history details.
  • The VCEP PS2 rule requires both maternity and paternity confirmation, no QT prolongation in the parents or family history of sudden unexplained death under age 40, a coding or flanking variant, and phenotype/proband-count data from Tables 1 and 2.
Still missing
  • Documented confirmation of both maternity and paternity, or trio whole-exome sequencing.
  • Parental QTc results and family history of sudden unexplained death before age 40.
  • Proband phenotype specificity and the VCEP Table 1/Table 2 information needed to assign strength.
Sources
PM3 Not assessed: c.1032G>A was reported in trans with c.569G>A, but the partner variant lacks a classification established under the KCNQ1 VCEP rules. Details ▾Hide ▴
Reasoning

The case contains a directly reported trans observation: in Family L151, KCNQ1 c.1032G>A was compound heterozygous with c.569G>A (p.Arg190Gln) in a proband with congenital deafness, recurrent syncope, and QTc 460 ms. However, the VCEP rule requires both variants to be classified using these specifications, and the available evidence does not provide a VCEP-specification-based classification of the partner c.569G>A variant. Therefore PM3 cannot be assigned a strength without importing an unsupported classification or external weighting scheme.

Evidence considered
  • ClinGen KCNQ1 VCEP PM3 rule: both variants must be classified using these rule specifications, and phase requires testing of parents or offspring.
  • Genotype-phenotype analysis of three Chinese families with Jervell and Lange-Nielsen syndrome, Family L151: the proband had compound heterozygous KCNQ1 c.1032G>A (p.Ala344Alasp) and c.569G>A (p.Arg190Gln); the report describes congenital deafness, recurrent syncope, and QTc 460 ms.
  • The available report establishes the trans observation but does not itself establish that c.569G>A reached Pathogenic or Likely Pathogenic classification under the KCNQ1 VCEP specifications.
Still missing
  • A VCEP-specification-based classification of the trans partner c.569G>A (p.Arg190Gln) is not available.
  • The VCEP directs use of ClinGen SVI recommendations for PM3 evidence weight, but the applicable weighting recommendation is not provided in the governing case materials.
Sources
PM6 VCEPNot assessed: de novo status is reported, but parental/family-history requirements and VCEP phenotype-strength data are incomplete. Details ▾Hide ▴
Reasoning

The exact c.1032G>A variant was reported as de novo in family 2915, which is compatible with PM6 because the VCEP does not require confirmed maternity or paternity. However, the available evidence does not establish the required absence of parental QT prolongation or qualifying family history, and it lacks the VCEP phenotype-specific and proband-count data needed to select a PM6 strength.

VCEP rule
Assumed de novo, but without confirmation of paternity and maternity. ... * For PM6, maternity and paternity are not confirmed but assumed, with no family history of disease (no evidence of QT-prolongation in parents or family history of sudden, unexplained death under the age of 40 years). ... * The PM6 strength level depends on the clinical phenotype specificity and number of probands as defined in Tables 1 and 2.
Evidence considered
  • PMID:10477533 reports that c.1032G>A appeared de novo in family 2915, but the extraction does not document parental testing status, parental QTc findings, or relevant family history.
  • The VCEP PM6 rule requires no family history of disease, a coding or flanking de novo variant, and phenotype-specific/proband-count information from the VCEP tables to determine strength.
Still missing
  • Evidence that maternity and paternity were unconfirmed but assumed.
  • Parental QTc results and family history of sudden unexplained death before age 40.
  • Proband phenotype specificity, number of probands, and VCEP Table 1/Table 2 inputs for strength assignment.
Sources
PP1 VCEPNot assessed: familial transmission is reported, but qualifying QTc, Schwartz-score, or syncope data needed to count affected relatives are unavailable. Details ▾Hide ▴
Reasoning

PMID:10477533 reports transmission of c.1032G>A from a grandfather to three grandchildren in family 10683, and PMID:22629021 reports the variant in a proband and daughter. The available extracts do not provide qualifying QTc values, Schwartz scores, or syncope status for the affected relatives, and the second report includes additional variants that complicate interpretation. Therefore the VCEP count threshold for PP1 cannot be established.

VCEP rule
Co-segregation with disease in multiple affected family members in a gene definitively known to cause the disease ... * Each affected family member must have Schwartz score (PMID: 36017572, Table 10) >3 or QTc greater than or equal to 480ms or syncope in order to be included / counted. ... * The proband + 3 affected family members with the variant meets PP1. ... * If any family member is affected but does not harbor the variant, use BS4 (non-segregation) instead.
Evidence considered
  • PMID:10477533 states that in family 10683 the variant was transmitted by the grandfather to three grandchildren, but the extracted report does not supply the qualifying clinical measurements required for counting them under PP1.
  • PMID:22629021 reports c.1032G>A in a proband and daughter, but the proband carried it in trans with c.569G>A and the daughter also carried a maternal c.574C>T variant, so this family requires human review before being counted as straightforward cosegregation.
  • The VCEP PP1 rule requires each counted affected family member to have Schwartz score >3, QTc >=480 ms, or syncope; PP1 Supporting requires the proband plus 3 affected family members with the variant.
Still missing
  • QTc, modified Schwartz score, or syncope status for each affected relative being counted.
  • A clear count of affected relatives carrying the variant under the VCEP definition.
  • Resolution of the additional-variant context in PMID:22629021 before using that family for PP1.
Sources
BS4 VCEPNot assessed: no affected family member is documented to lack c.1032G>A, so neither the one-person nor two-person BS4 threshold is evaluable. Details ▾Hide ▴
Reasoning

The reviewed evidence reports familial transmission of c.1032G>A but does not identify an affected family member who lacks the variant. No qualifying non-segregation observation is available, and therefore neither the VCEP BS4 Supporting threshold of one affected noncarrier nor the Strong threshold of two affected noncarriers can be evaluated as met.

VCEP rule
Lack of segregation in affected members of a family ... * BS4\_supporting is met by absence of the variant in 1 affected family member ... * The family member must have QTc greater than or equal to 480ms or Schwartz score >3 or syncope.
Evidence considered
  • PMID:10477533 describes transmission of c.1032G>A in family 10683 and a de novo occurrence in family 2915; it does not document an affected noncarrier.
  • PMID:22629021 reports the variant in the proband and daughter and does not document an affected family member lacking the variant.
  • The VCEP BS4 rule requires absence of the variant in 1 affected family member for Supporting or 2 affected family members for Strong, with QTc >=480 ms, Schwartz score >3, or syncope.
Still missing
  • Genotype and qualifying phenotype data for affected relatives who do not carry the variant, if any.
Sources
Not applicable · 13· recorded as not applicable Show reasons ▾Hide reasons ▴
PVS1 N/ANot applicable: c.1032G>A is synonymous, p.(Ala344=), while the VCEP PVS1 rule applies only to truncating variants. Details ▾Hide ▴
Reasoning

PVS1 is not applicable because NM_000218.3:c.1032G>A is a synonymous variant, NP_000209.2:p.(Ala344=), rather than a truncating variant. The VCEP PVS1 rule is explicitly limited to truncating variants; although publications show that this synonymous change alters splicing, that evidence does not convert the variant into the truncating variant type named by the VCEP PVS1 rule.

VCEP rule
For truncating variants, apply PVS1 at default (VeryStrong) level if the variant affects codons 1-581, since nonsense-mediated decay is predicted.
Evidence considered
  • pvs1_variant_assessment: NM_000218.3:c.1032G>A; NP_000209.2:p.(Ala344=); exon 7; consequence_class synonymous.
  • PMID:10477533, Results and Discussion: c.1032G>A is described as not changing the encoded alanine, while RT-PCR showed loss of exons 6 and 7 in the mutant transcript.
  • PMID:17292394, Results sections 3.1–3.6: c.1032G>A is a synonymous change at codon 344 with aberrant exon-skipping transcripts.
  • PMID:21810471, Results sections 3.3–3.7: c.1032G>A is a synonymous A344A change that alters splicing and reduces modeled potassium currents.
  • PMID:29857160, Results: c.1032G>A is studied as the synonymous KCNQ1-A344Aspl mutation with multiple aberrant splice products.
Sources
PS1 N/ANot applicable: c.1032G>A is synonymous, p.Ala344=, so it makes no amino-acid change eligible for the VCEP's PS1 comparison rule. Details ▾Hide ▴
Reasoning

The VCEP PS1 rule requires the same amino acid change as a previously established pathogenic variant. NM_000218.3:c.1032G>A is synonymous, NP_000209.2:p.(Ala344=), so it does not produce an amino-acid change to compare under PS1. Although PMID:10477533 describes recurrent disease-associated c.1032G>A at codon 344, that is the same synonymous splice-altering variant and does not satisfy the VCEP's same-amino-acid-change PS1 route.

VCEP rule
Same amino acid change as a previously established pathogenic variant regardless of nucleotide change. Example: Val->Leu caused by either G>C or G>T in the same codon. Caveat: Beware of changes that impact splicing rather than at the amino acid/protein level.
Evidence considered
  • Case normalization identifies NM_000218.3:c.1032G>A as NP_000209.2:p.(Ala344=), a synonymous variant.
  • PMID:10477533 reports the same c.1032G>A variant at codon 344 and describes its splice effect; it does not provide a different pathogenic amino-acid substitution at residue 344 for PS1.
Sources
PM1 N/ANot applicable: residue 344 lies outside the VCEP-defined PM1 pore-helix interval of amino acids 300-320, and no additional KCNQ1 domain-table regions are supplied. Details ▾Hide ▴
Reasoning

The KCNQ1 VCEP limits PM1 to a rare variant within the pore helix at amino acids 300 to 320, with absence of likely benign or benign variation in that region. The variant is at residue 344, outside 300-320. The authoritative vcep_materials.json domain_tables entry for KCNQ1 is empty, so there are no additional approved domain-table regions to evaluate. PMID:10477533 calls codon 344 a recurrent mutation hotspot, but the KCNQ1 VCEP PM1 specification does not name a codon-344 hotspot route; therefore that observation cannot establish PM1.

VCEP 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 ... The variant must be rare (meeting PM2\_Supporting) in order to be considered for PM1. ... Met by a rare variant within the pore\u00a0helix (amino acids 300 to 320). This region is known to be a critical region of KCNQ1 and has been confirmed to show an absence of likely benign or benign variants listed in gnomAD.
Evidence considered
  • The VCEP PM1 specification defines the qualifying KCNQ1 region as the pore helix, amino acids 300 to 320; the variant is p.Ala344=.
  • gnomAD v4.1 reports maximum observed continental-population AF 1.7011605317147357e-06, below the VCEP PM2_Supporting cutoff of <0.00001, so rarity does not overcome the residue-location requirement.
  • PMID:10477533 describes codon 344 as a recurrent mutation hotspot, but the VCEP PM1 rule specifies only the pore-helix route and does not name this hotspot source or route.
Sources
PM4 N/ANot applicable: p.(Ala344=) causes no protein length change and is neither an in-frame indel nor a stop-loss variant. Details ▾Hide ▴
Reasoning

PM4 is not applicable because the variant is synonymous and produces no protein length change. The VCEP PM4 rule names only protein length changes due to in-frame deletions/insertions in a non-repeat region or stop-loss variants; c.1032G>A is neither an in-frame indel nor a stop-loss variant.

VCEP rule
Protein length changes due to in-frame deletions/insertions in a non-repeat region or stop-loss variants
Evidence considered
  • pvs1_variant_assessment: NP_000209.2:p.(Ala344=); consequence_class synonymous.
  • PMID:10477533, Results and Discussion: the c.1032G>A substitution should not affect the encoded alanine, although it can cause abnormal splicing.
Sources
cspec ↗pvs1_variant_assessmentPMID:10477533 ↗
PM5 N/ANot applicable: p.Ala344= is synonymous, whereas the VCEP PM5 rule requires a novel missense change. Details ▾Hide ▴
Reasoning

The VCEP PM5 rule requires a novel missense change at a residue where a different pathogenic missense change has been seen. NM_000218.3:c.1032G>A is synonymous, p.Ala344=, so it is outside the variant type named by the rule and cannot receive PM5.

VCEP rule
Novel missense change at an amino acid residue where a different missense change determined to be pathogenic has been seen before.
Evidence considered
  • Case normalization identifies the consequence as synonymous, NP_000209.2:p.(Ala344=).
  • No same-residue missense comparator is relevant because the queried variant is not missense.
Sources
PP2 N/ANot applicable: the VCEP excludes PP2 for KCNQ1 because benign variation is present throughout the gene and its missense constraint Z-score is 1.83. Details ▾Hide ▴
Reasoning

The VCEP PP2 entry explicitly marks the criterion not applicable to KCNQ1 because benign variation is present throughout the gene and the missense constraint Z-score is 1.83, lower than 3. The queried variant is also synonymous rather than missense.

VCEP 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 * Not applicable due to presence of benign variation throughout the _KCNQ1_ gene (since the missense constraint Z-score in gnomAD is 1.83, lower than 3).
Evidence considered
  • The VCEP PP2 rule states that PP2 is not applicable to KCNQ1 because of benign variation throughout the gene and gives a missense constraint Z-score of 1.83, lower than 3.
  • The case variant is synonymous, p.Ala344=, not missense.
Sources
BS2 N/ANot applicable: the KCNQ1 VCEP excludes BS2 because disease phenotypes are incompletely penetrant, including in homozygotes. Details ▾Hide ▴
Reasoning

The VCEP explicitly marks BS2 not applicable because KCNQ1 has incomplete penetrance; it specifically notes that hearing loss and other phenotypes are not completely penetrant in homozygotes. The available gnomAD data also show zero homozygotes, but that observation is not needed because the VCEP rule itself excludes the criterion.

VCEP 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. ... * Not applicable due to incomplete penetrance. ... * Please note that hearing loss and other phenotypes are not completely penetrant in homozygotes (PMID: 23392653, [https://www.ncbi.nlm.nih.gov/books/NBK1405/#jln.Summary](https://www.ncbi.nlm.nih.gov/books/NBK1405/#jln.Summary)).
Evidence considered
  • ClinGen KCNQ1 CSPEC BS2 rule states: Not applicable due to incomplete penetrance, and hearing loss and other phenotypes are not completely penetrant in homozygotes.
  • gnomAD v4.1 reports 0 homozygotes and gnomAD v2.1 reports 0 homozygotes for this variant; BS2 remains not applicable under the VCEP rule.
Sources
BP1 N/ANot applicable: the VCEP excludes BP1 for KCNQ1 because pathogenic variants are not limited to truncating variants and include missense variants. Details ▾Hide ▴
Reasoning

The VCEP BP1 entry explicitly states that BP1 is not applicable to KCNQ1 because pathogenic KCNQ1 variants are not limited to truncating variants and can be missense. The queried variant is synonymous, but this gene-level VCEP exclusion independently prevents BP1 application.

VCEP rule
Missense variant in a gene for which primarily truncating variants are known to cause disease * Not applicable, as pathogenic _KCNQ1_ variants are not limited to truncating variants, but can be missense as well.
Evidence considered
  • The VCEP BP1 rule explicitly states that BP1 is not applicable to KCNQ1 because pathogenic KCNQ1 variants can be missense as well as truncating.
  • The case variant is synonymous, p.Ala344=.
Sources
BP2 N/ANot applicable: the KCNQ1 VCEP excludes BP2 because biallelic KCNQ1 cases cause Jervell and Lange-Nielsen syndrome. Details ▾Hide ▴
Reasoning

The KCNQ1 VCEP explicitly makes BP2 not applicable because KCNQ1 has biallelic cases causing Jervell and Lange-Nielsen syndrome. No BP2 assessment is therefore performed.

VCEP 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. ... Not applicable to KCNQ1 due to biallelic cases (Jervell and Lange-Nielsen syndrome)
Evidence considered
  • ClinGen KCNQ1 VCEP BP2 rule entry states: Not applicable to KCNQ1 due to biallelic cases (Jervell and Lange-Nielsen syndrome).
Sources
BP3 N/ANot applicable: the KCNQ1 VCEP explicitly excludes BP3 for KCNQ1, regardless of repeat-region context. Details ▾Hide ▴
Reasoning

BP3 is not applicable under the KCNQ1 VCEP specification, which explicitly states that this criterion is not applicable to KCNQ1. The variant is also not an in-frame deletion or insertion in a repetitive region.

VCEP rule
In-frame deletions/insertions in a repetitive region without a known function * Not applicable to KCNQ1
Evidence considered
  • KCNQ1 CSPEC BP3 entry: the rule includes the explicit applicability statement that BP3 is not applicable to KCNQ1.
Sources
BP5 N/ANot applicable: the reported phenotype is KCNQ1-consistent, whereas the VCEP limits BP5 to another LQTS phenotype or insufficiently specific clinical details. Details ▾Hide ▴
Reasoning

The VCEP BP5 rule excludes BP5 when the phenotype indicates KCNQ1 as the cause; it is reserved for phenotypes matching another LQTS form caused by KCNH2, SCN5A, or KCNE1, or for insufficiently specific phenotype details. The available case reports document LQT1-consistent exercise/swimming-associated QT prolongation and the exact variant in KCNQ1, including a compound KCNQ1 case, so the VCEP exclusion applies.

VCEP rule
Variant found in a case with an alternate molecular basis for disease * Caveat: BP5 is not applicable when the phenotypes (ie: trigger type; PMID: 32882399, 11136691, 18373596 or treadmill stress test; PMID: 21699858) indicate _KCNQ1_ as the cause. BP5 is only applicable when the phenotypes match another form of LQTS (caused by a variant in _KCNH2_, _SCN5A_, or _KCNE1_, PMID: 19862833, PMID: 31941373, PMID: 33517668) or when phenotype details are not sufficiently specific. * Note: The rate of cases with multiple suspected deleterious variants in the same or different LQTS-associated genes may be relatively high (5.2% in one cohort, PMID: 24667783). The group will consider this possibility during the pilot.
Evidence considered
  • VCEP BP5 caveat: BP5 is not applicable when trigger type or treadmill testing indicates KCNQ1 as the cause; BP5 is only applicable when phenotypes match another LQTS form caused by KCNH2, SCN5A, or KCNE1, or when phenotype details are not sufficiently specific.
  • Tsuji-Wakisaka et al. 2011 (PMID:21810471): among 9 c.1032G>A probands, cardiac events were predominantly exercise-associated and especially swimming-triggered, consistent with LQT1.
  • Wang et al. 2012 (PMID:22629021): the c.1032G>A variant was found in a compound KCNQ1 genotype in Family L151, with JLNS/RWS phenotypes and QTc 460-530 ms.
  • Hasegawa et al. 2018 (PMID:29857160): the exact variant was associated with ventricular fibrillation during swimming and exercise-induced QTc prolongation to 500 ms.
Sources
BP6 VCEPNot applicable: the KCNQ1 VCEP explicitly prohibits use of BP6 regardless of available external benign assertions. Details ▾Hide ▴
Reasoning

The KCNQ1 VCEP marks BP6 as not applicable and states that the criterion is not for use as recommended by the ClinGen Sequence Variant Interpretation VCEP Review Committee; therefore no reputable-source assertion is evaluated under BP6.

VCEP rule
This criterion is not for use as recommended by the ClinGen Sequence Variant Interpretation VCEP Review Committee.
Evidence considered
  • The KCNQ1 VCEP BP6 entry states: this criterion is not for use as recommended by the ClinGen Sequence Variant Interpretation VCEP Review Committee.
Sources
BP7 N/ANot applicable: The synonymous variant is at the last base of an exon, within the VCEP BP7 exclusion for the last three exon nucleotides. Details ▾Hide ▴
Reasoning

The VCEP limits BP7 to synonymous variants except those in the last three nucleotides of an exon or the first nucleotide of an exon. The variant is synonymous and is documented at the last base of an exon, placing it within the VCEP's explicit exclusion; therefore BP7 is not applicable before PhyloP or splice-prediction sufficiency is considered.

VCEP rule
A synonymous variant for which splicing prediction algorithms predict no impact to the splice consensus sequence nor the creation of a new splice site AND the nucleotide is not highly conserved. * Use SpliceAI to look for suspected splicing defects (cutoff Δ score \<0.1). * Use PhyloP to check for conservation (cutoff \<2.0). * Please note that SpliceAI Δ score \<0.1 AND PhyloP score \<2.0 must both be met. * This code can be met by synonymous variants except for variants in the last 3 nucleotides of an exon, or in the 1st nucleotide of an exon. * This code can be met by intronic variants except for variants in positions +1 to +6 or -1 to -20, which are considered part of the splice donor and splice acceptor sites (PMID: 37352859).
Evidence considered
  • The variant is synonymous: NM_000218.3:c.1032G>A, NP_000209.2:p.(Ala344=).
  • Murray et al. (PMID:10477533) describes c.1032G>A as occurring at the last base of the exon: "because it is the last base of the exon".
Sources

Identifiers

Gene
KCNQ1
Transcript
NM_000218.3
Coding (HGVS c.)
NM_000218.3:c.1032G>A
Protein (HGVS p.)
NP_000209.2:p.(Ala344=)
GRCh38
chr11:2583545 G>A
GRCh37
chr11:2604775 G>A
Location and type
Exon 7 · synonymous
ClinVar
3386939, 3135, 578178, 560649, 52938, 52937

Gene diagram

Every interpreted variant in KCNQ1, mapped onto the exon structure of NM_000218.3. Select a row to find it on the plot.

KCNQ1NM_000218.3
Fetching transcript structure from UCSC…
gnomAD v4.1 2 / 1,609,160 alleles AF 1.24e-06 · 0 homozygotes · FAF 2.8e-07
gnomAD v2.1 1 / 251,186 alleles AF 3.98e-06 · 0 homozygotes
gnomAD-Canada v1.0 Allele count data not recorded

By genetic ancestry

gnomAD v4.1

AF 1.2e-06 · 2 / 1,609,160 alleles · 0 hom · FAF 2.8e-07
European (non-Finnish)2 / 1,175,668 1.7e-06
0 alternate alleles recorded in 9 other groups: Remaining individuals, Admixed American, European (Finnish), Amish, East Asian, Middle Eastern, South Asian, Ashkenazi Jewish, African/African American.

gnomAD v2.1

AF 4e-06 · 1 / 251,186 alleles · 0 hom
European (non-Finnish)1 / 113,522 8.8e-06
0 alternate alleles recorded in 7 other groups: African/African American, Admixed American, Ashkenazi Jewish, East Asian, European (Finnish), Remaining individuals, South Asian.

Statements

gnomAD v4.1

This variant is present in gnomAD v4.1 (AF= 1.24288e-06; MAF= 0.00012%, 2/1609160 alleles, homozygotes = 0) and has highest observed frequency in the European (non-Finnish) population (AF= 1.70116e-06; MAF= 0.00017%, 2/1175668 alleles, homozygotes = 0); grpmax FAF= 2.8e-07.

gnomAD v2.1

This variant is present in gnomAD v2.1 (AF= 3.98111e-06; MAF= 0.00040%, 1/251186 alleles, homozygotes = 0) and has highest observed frequency in the European (non-Finnish) population (AF= 8.80887e-06; MAF= 0.00088%, 1/113522 alleles, homozygotes = 0).

gnomAD-Canada

Not available in gnomAD-Canada v1.0.

SpliceAI and Pangolin

SpliceAI acceptor lossat -110 bp
0.005
SpliceAI acceptor gainat -1 bp
0.000
SpliceAI donor lossat +0 bp
0.382
SpliceAI donor gainat +15 bp
0.490
Pangolin splice lossmagnitude shown
-0.370
Pangolin splice gain
0.308

Other predictors

REVEL
Not available
BayesDel
Not available

How the predictions were used

PP3 SupportingVCEPMet: SpliceAI maximum delta score 0.49, including donor-gain 0.49 and donor-loss 0.382, exceeds the VCEP PP3 threshold of ≥0.2. Details ▾Hide ▴
Reasoning

The VCEP applies PP3 to computational evidence of a deleterious effect and specifically permits SpliceAI evidence when any donor-gain, donor-loss, acceptor-gain, or acceptor-loss delta score is greater than or equal to 0.2. For this synonymous KCNQ1 variant, SpliceAI reports DS_DG 0.49 and DS_DL 0.382, with a maximum delta score of 0.49, meeting the VCEP threshold. REVEL was not used because it was not available and is not needed for the VCEP's SpliceAI path.

VCEP rule
Multiple lines of computational evidence support a deleterious effect on the gene or gene product (conservation, evolutionary, splicing impact, etc) * REVEL and SpliceAI are the preferred predictors * Apply this code if REVEL score is greater than or equal to 0.75. * Use SpliceAI to look for a possible splicing defect. Apply this code if delta score for donor gain, donor loss, acceptor gain, or acceptor loss is greater than or equal to 0.2 (PMID: 37352859).
Evidence considered
  • SpliceAI Lookup for NM_000218.3:c.1032G>A: DS_AG 0.0, DS_AL 0.005, DS_DG 0.49, DS_DL 0.382; maximum delta score 0.49.
  • The variant is synonymous: NP_000209.2:p.(Ala344=).
Sources
BP4 VCEPNot met: SpliceAI maximum delta score 0.49 is above the VCEP BP4 synonymous-variant cutoff of <0.1. Details ▾Hide ▴
Reasoning

The VCEP permits BP4 for a synonymous variant when SpliceAI predicts no splice defect, specifically requiring every donor-gain, donor-loss, acceptor-gain, and acceptor-loss delta score to be less than 0.1. This variant has SpliceAI DS_DG 0.49 and DS_DL 0.382, with maximum delta score 0.49, so the required no-splicing-impact condition is not met.

VCEP rule
Multiple lines of computational evidence suggest no impact on gene or gene product (conservation, evolutionary, splicing impact, etc.)  * REVEL and SpliceAI are the preferred predictors * Apply this code for a missense variant if the REVEL score is \<0.25 AND no splicing defect is predicted according to SpliceAI. * Use SpliceAI to look for a possible splicing defect. Apply this code if delta score for donor gain, donor loss, acceptor gain, or acceptor loss is \<0.1 (in addition to REVEL score \<0.25). * Apply this code for a synonymous or intronic variant if delta score for donor gain, donor loss, acceptor gain, or acceptor loss is \<0.1 (PMID: 37352859).
Evidence considered
  • SpliceAI Lookup for NM_000218.3:c.1032G>A: DS_AG 0.0, DS_AL 0.005, DS_DG 0.49, DS_DL 0.382; maximum delta score 0.49.
  • The VCEP's synonymous/intronic BP4 path does not require REVEL; the splice requirement fails on the observed SpliceAI scores.
Sources
BP7 N/ANot applicable: The synonymous variant is at the last base of an exon, within the VCEP BP7 exclusion for the last three exon nucleotides. Details ▾Hide ▴
Reasoning

The VCEP limits BP7 to synonymous variants except those in the last three nucleotides of an exon or the first nucleotide of an exon. The variant is synonymous and is documented at the last base of an exon, placing it within the VCEP's explicit exclusion; therefore BP7 is not applicable before PhyloP or splice-prediction sufficiency is considered.

VCEP rule
A synonymous variant for which splicing prediction algorithms predict no impact to the splice consensus sequence nor the creation of a new splice site AND the nucleotide is not highly conserved. * Use SpliceAI to look for suspected splicing defects (cutoff Δ score \<0.1). * Use PhyloP to check for conservation (cutoff \<2.0). * Please note that SpliceAI Δ score \<0.1 AND PhyloP score \<2.0 must both be met. * This code can be met by synonymous variants except for variants in the last 3 nucleotides of an exon, or in the 1st nucleotide of an exon. * This code can be met by intronic variants except for variants in positions +1 to +6 or -1 to -20, which are considered part of the splice donor and splice acceptor sites (PMID: 37352859).
Evidence considered
  • The variant is synonymous: NM_000218.3:c.1032G>A, NP_000209.2:p.(Ala344=).
  • Murray et al. (PMID:10477533) describes c.1032G>A as occurring at the last base of the exon: "because it is the last base of the exon".
Sources

Statement

In silico

SpliceAI predicts possible splice impact for this variant (max delta score = 0.49).

9 paper records listed. 5 cited in the classification.

Cited in the classification

  • Splicing mutations in KCNQ1: a mutation hot spot at codon 344 that produces in frame transcripts.
    Murray A et al. · 1999 Sep 7
    The paper explicitly describes KCNQ1 c.1032G>A as a silent codon-344 change that should not alter the encoded alanine, while reporting abnormal transcript processing with loss of exons 6 and 7 in affected-family samples.
    → PS3 · strong → PS4 · supporting Names this variant
    PMID 10477533 ↗
    Source detail
    In families 10683 and 2915, a G to A transition was found at position 1032. This transition of the last base of codon 344 has already been described in 5 families. As in family 10738 above, it should not affect the encoded alanine; however, because it is the last base of the exon, it has been suggested to cause abnormal splicing, although this has not been demonstrated.

    Location Results, Molecular Genetics; Discussion

    Context Affected-family case observations, segregation analysis, and RT-PCR with sequencing of KCNQ1 transcripts from lymphoblastoid cell lines; the 1032 G>A transcripts showed loss of exons 6 and 7.

  • Mechanistic basis for the pathogenesis of long QT syndrome associated with a common splicing mutation in KCNQ1 gene.
    Tsuji K et al. · 2007 Mar
    The paper explicitly studied KCNQ1 c.1032G>A as a synonymous A344A change and documented aberrant exon-skipping transcripts and abnormal channel behavior.
    → PS3 · strong → PS4 · supporting Names this variant
    PMID 17292394 ↗
    Source detail
    DNA sequencing identified a heterozygous guanine to adenine change in KCNQ1 at nucleotide 1032 (c.1032G>A)

    Location Results, sections 3.1–3.6; Discussion, sections 4.1–4.3

    Context Three unrelated long-QT-syndrome families; six affected individuals; peripheral-blood leukocyte RT-PCR and real-time RT-PCR; heterologous expression in Xenopus laevis oocytes with two-electrode voltage clamp; GFP confocal microscopy and CFP/YFP FRET in COS7 cells.

  • Identification and functional characterization of KCNQ1 mutations around the exon 7-intron 7 junction affecting the splicing process.
    Tsuji-Wakisaka K et al. · 2011 Nov
    The paper describes c.1032G>A as a synonymous A344A change and reports patient-RNA and minigene evidence of exon-skipping transcripts, with reduced modeled potassium currents.
    → PS3 · strong → PS4 · supporting → PP4 · supporting Names this variant
    PMID 21810471 ↗
    Source detail
    In addition to c.1032GNA mutation, IVS7 +3ANG generates exon-skipping mRNAs, and thereby causing LQT1 phenotype.

    Location Abstract; Introduction; Results sections 3.3–3.7; Discussion sections 4.1–4.3; Fig. 4 and Fig. 5

    Context KCNQ1 exon 7 minigene splicing assays in COS7 cells, with confirmation in CHO and HL-1 cells; RT-PCR and real-time RT-PCR of patient lymphocyte RNA; Xenopus laevis oocyte two-electrode voltage-clamp recordings with KCNE1; one-dimensional human ventricular computer simulations; nine probands from nine unrelated families carrying c.1032G>A.

  • Genotype-phenotype analysis of three Chinese families with Jervell and Lange-Nielsen syndrome.
    Gao Y et al. · 2012 Apr
    The paper reports c.1032G>A in a proband and daughter in Family L151; the proband also carried c.569G>A and the daughter inherited an additional maternal c.574C>T variant, so the family provides potentially confounded transmission evidence rather than a clean single-variant segregation count.
    → PS4 · supporting Names this variant
    PMID 22629021 ↗
    Source detail
    Compound heterozygous mutations c.1032G>A (p.Ala344Alasp) and c.569G>A (p.Arg190Gln) were identified in the proband. His daughter, who displayed a RWS phenotype, inherited c.1032G>A (p.Ala344Alasp) from him and novel missense mutation c.574C>T (p.Arg192Cys) from her mother who was a silent mutation carrier.

    Location Results, Clinical characteristics and mutation finding in Family L151; Figure 4; Discussion

    Context Three Chinese Jervell and Lange-Nielsen syndrome kindreds with PCR/direct sequencing, family genotyping, and comparison against 100 control alleles.

  • Complex aberrant splicing in the induced pluripotent stem cell-derived cardiomyocytes from a patient with long QT syndrome carrying KCNQ1-A344Aspl mutation.
    The paper explicitly studied c.1032G>A as the synonymous KCNQ1-A344Aspl mutation and documented multiple aberrant splice products in patient-derived cardiomyocytes.
    → PS3 · strong → PP4 · supporting Names this variant
    PMID 29857160 ↗
    Source detail
    We identified seven aberrant RNA variants in A344Aspl-hiPSC-CMs, more complex compared with those in the peripheral lymphocytes.

    Location Results: Clinical phenotypes and genetic analysis; Complex aberrant RNA splicing was observed in KCNQ1-A344Aspl hiPSC-CMs; electrophysiology sections

    Context Patient-derived KCNQ1-A344Aspl hiPSCs differentiated into cardiomyocytes; KCNQ1 exon 5–10 cDNA cloning and quantitative RT-PCR for splice variants; multi-electrode-array field-potential recordings; perforated patch-clamp action-potential recordings; comparison with healthy control hiPSC-cardiomyocytes.

Other recorded publications

  • Spectrum of mutations in long-QT syndrome genes. KVLQT1, HERG, SCN5A, KCNE1, and KCNE2.
    Splawski I et al. · 2000
    No paper-specific finding is recorded.
    PMID 10973849 ↗
  • Aberrant 5' splice sites in human disease genes: mutation pattern, nucleotide structure and comparison of computational tools that predict their utilization.
    Buratti E et al. · 2007
    No paper-specific finding is recorded.
    PMID 17576681 ↗
  • Recommendations of the Scientific Committee of the Italian Beckwith-Wiedemann Syndrome Association on the diagnosis, management and follow-up of the syndrome.
    No paper-specific finding is recorded.
    PMID 26592461 ↗
  • HRS/EHRA expert consensus statement on the state of genetic testing for the channelopathies and cardiomyopathies: this document was developed as a partnership between the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA).
    No paper-specific finding is recorded.
    PMID 21810866 ↗

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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= 1.24288e-06; MAF= 0.00012%, 2/1609160 alleles, homozygotes = 0) and has highest observed frequency in the European (non-Finnish) population (AF= 1.70116e-06; MAF= 0.00017%, 2/1175668 alleles, homozygotes = 0); grpmax FAF= 2.8e-07.

gnomAD v2.1

This variant is present in gnomAD v2.1 (AF= 3.98111e-06; MAF= 0.00040%, 1/251186 alleles, homozygotes = 0) and has highest observed frequency in the European (non-Finnish) population (AF= 8.80887e-06; MAF= 0.00088%, 1/113522 alleles, homozygotes = 0).

gnomAD-Canada

Not available in gnomAD-Canada v1.0.

ClinVar

This variant has been reported in ClinVar as Pathogenic (15 clinical laboratories) and as Pathogenic by ClinGen Potassium Channel Arrhythmia Variant Curation Expert Panel, ClinGen (expert panel). (ClinVarID = 3135)

In silico

SpliceAI predicts possible splice impact for this variant (max delta score = 0.49).

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.