About TSC2
No gene-level summary was recorded for this case.
No variant summary was recorded for this case.
Five-step scale from benign to pathogenic. This variant is benign. Select a step to read what it means.
Benign.A benign classification under the recorded framework.
Gene-level background from the recorded interpretation.
Words with a dotted underline have a short definition. Hover or tap them.No gene-level summary was recorded for this case.
The recorded framework is Not recorded. The criteria and strengths shown below come from the saved assessment; this page does not recalculate the classification.
The applied criteria and their strengths are shown as assessed under the stated framework.
No pathogenic criterion marked as applied in the recorded assessment.
The allele frequency of NM_000548.5:c.729C>G exceeds the BS1 threshold of >0.3% in the general population. gnomAD v2.1: 0.355% (1000/281,464 alleles, 0 homozygotes), gnomAD v4.1: 0.316% (5,099/1,612,278 alleles, 10 homozygotes). This frequency is substantially greater than expected for TSC2-associated tuberous sclerosis complex (incidence ~1:6,000-10,000).
NM_000548.5:c.729C>G has been observed in 10 homozygous individuals in gnomAD v4.1 (total AF=0.316%, 5,099 heterozygous alleles). Tuberous sclerosis complex is a dominant disorder with high penetrance. Observation of homozygotes and thousands of heterozygotes in a population database of generally healthy individuals constitutes strong evidence for a benign role.
Multiple lines of computational evidence suggest no impact on gene product. SpliceAI predicts no significant splice alteration (max delta score = 0.01). NM_000548.5:c.729C>G is a synonymous variant (p.Leu243=) at a nucleotide position where in silico splicing predictions support a null effect.
Multiple reputable clinical laboratories consistently classify NM_000548.5:c.729C>G as Benign or Likely benign in ClinVar (Variation ID 49382). Fifteen clinical laboratories classify as Benign and six as Likely benign, with criteria provided. No submitting laboratory has asserted pathogenicity.
NM_000548.5:c.729C>G is a synonymous variant (p.Leu243=) for which splicing prediction algorithms predict no impact on splicing. SpliceAI max delta score is 0.01, well below the 0.10 threshold for predicted splice alteration. The nucleotide is not evolutionarily constrained to a degree suggesting functional importance.
gene-specific framework lacked a usable explicit final combination framework, so generic ACMG/AMP 2015 final-combination rules were applied as fallback; applied criteria: BS1 strong benign, BS2 strong benign, BP4 supporting benign, BP6 supporting benign, BP7 supporting benign; combination = 2 strong benign + 3 supporting benign, which maps to Benign.
Evidence summaries and captured source records, where available. Missing entries should not be interpreted as negative findings.
gnomAD v4.1: 5,099 / 1,612,278 alleles. Recorded AF 0.00316261. Recorded homozygote count 10.
This variant is present in gnomAD v2.1 (AF= 0.00355285; MAF= 0.35529%, 1000/281464 alleles, homozygotes = 0) and has highest observed frequency in the European (Finnish) population (AF= 0.0119589; MAF= 1.19589%, 284/23748 alleles, homozygotes = 0); grpmax FAF= 0.0056912.
Recorded SpliceAI maximum delta score: 0.010. Refer to the recorded PP3/BP4 rationale for interpretation.
15 Benign · 6 Likely benign.
OncoKB identified curated literature and non-variant-specific oncogenicity context for review; listed oncogenicity label: Unknown Oncogenic Effect.
This variant has previously been reported in somatic cancers (COSMIC; COSV104587071, n = 2 times).
This variant does not lie in a statistically significant hotspot.
ACMG/AMP criteria under Not recorded, with the data and sources behind each one.
26 criteria with recorded statuses: 5 met · 11 not met · 5 not assessed · 5 not applicable. Open any row for the full reasoning, the rule and the evidence behind it.
NM_000548.5:c.729C>G (p.Leu243=) is a synonymous variant in exon 8 of TSC2 with an overall allele frequency of 0.316-0.355% in gnomAD, exceeding the BS1 threshold of >0.3%.
This variant has been observed in 10 homozygous individuals in gnomAD v4.1 among 1,612,278 alleles, constituting strong evidence for benignity in a dominant disorder (BS2).
SpliceAI predicts no splice impact (max delta = 0.01), and the variant is synonymous with no predicted effect on protein sequence, supporting multiple benign computational evidence lines (BP4, BP7).
ClinVar classifies this variant as Benign/Likely benign across 21 clinical laboratory submissions (15 Benign, 6 Likely benign), with criteria provided and no conflicting pathogenic interpretations (BP6).
No pathogenic criteria are met. PVS1, PS1, and PM5 are not applicable to this synonymous variant. PS2, PS3, PS4, PS5, PM1, PM2, PM6, PP3, and PP5 are not met. PP1, PP4, BS4, BP2, and BP5 are not assessed due to absence of data. BA1 is not met (overall AF <1%). BP1 and PP2 are not applicable to synonymous variants.
Applying generic ACMG/AMP 2015 final combination rules: two strong benign criteria (BS1, BS2) alone satisfy the classification threshold for Benign. Additionally, three supporting benign criteria (BP4, BP6, BP7) reinforce the benign classification.
No criteria match.
Every interpreted variant in TSC2, mapped onto the exon structure of NM_000548.5. Select a row to find it on the plot.
| Protein | Location | Classification | Link |
|---|
| European (Finnish)753 / 62,138 | 0.0124 hom |
| Ashkenazi Jewish119 / 29,606 | 0.004 |
| European (non-Finnish)3696 / 1,180,020 | 0.00315 hom |
| Remaining individuals193 / 62,492 | 0.0031 |
| South Asian210 / 91,084 | 0.0023 |
| Admixed American94 / 60,024 | 0.00161 hom |
| Middle Eastern3 / 6,062 | 0.00049 |
| African/African American31 / 75,050 | 0.00041 |
| European (Finnish)284 / 23,748 | 0.012 |
| Ashkenazi Jewish47 / 10,370 | 0.0045 |
| Remaining individuals30 / 7,218 | 0.0042 |
| European (non-Finnish)507 / 129,170 | 0.0039 |
| South Asian57 / 30,616 | 0.0019 |
| Admixed American59 / 35,438 | 0.0017 |
| African/African American16 / 24,956 | 0.00064 |
This variant is present in gnomAD v4.1 (AF= 0.00316261; MAF= 0.31626%, 5099/1612278 alleles, homozygotes = 10) and has highest observed frequency in the European (Finnish) population (AF= 0.0121182; MAF= 1.21182%, 753/62138 alleles, homozygotes = 4); grpmax FAF= 0.00304706.
This variant is present in gnomAD v2.1 (AF= 0.00355285; MAF= 0.35529%, 1000/281464 alleles, homozygotes = 0) and has highest observed frequency in the European (Finnish) population (AF= 0.0119589; MAF= 1.19589%, 284/23748 alleles, homozygotes = 0); grpmax FAF= 0.0056912.
SpliceAI predicts no significant splice impact for this variant (max delta score = 0.01).
9 paper records listed. No publication is explicitly linked to an applied criterion in the recorded metadata. None of the listed paper records explicitly indicates that the variant is named.
Screenshots represent source records captured during evidence collection. Select one to view the recorded source content.
The evidence statements recorded by the interpretation pipeline. They have not been reinterpreted by the page.
This variant is present in gnomAD v4.1 (AF= 0.00316261; MAF= 0.31626%, 5099/1612278 alleles, homozygotes = 10) and has highest observed frequency in the European (Finnish) population (AF= 0.0121182; MAF= 1.21182%, 753/62138 alleles, homozygotes = 4); grpmax FAF= 0.00304706.
This variant is present in gnomAD v2.1 (AF= 0.00355285; MAF= 0.35529%, 1000/281464 alleles, homozygotes = 0) and has highest observed frequency in the European (Finnish) population (AF= 0.0119589; MAF= 1.19589%, 284/23748 alleles, homozygotes = 0); grpmax FAF= 0.0056912.
This variant has been reported in ClinVar as Benign (15 clinical laboratories) and as Likely benign (6 clinical laboratories). (ClinVarID = 49382)
SpliceAI predicts no significant splice impact for this variant (max delta score = 0.01).
OncoKB identified curated literature and non-variant-specific oncogenicity context for review; listed oncogenicity label: Unknown Oncogenic Effect.
This variant does not lie in a statistically significant hotspot. This variant has previously been reported in somatic cancers (COSMIC; COSV104587071, n = 2 times).
This variant does not lie in a statistically significant hotspot.