Statement Types¶
ClinVar-GKS groups ClinVar submissions into 14 unique statement types. Several of these types are no longer accepted by ClinVar but exist historically.
| # | Statement Type | Proposition Profile | Statement Category |
|---|---|---|---|
| G.01 | Pathogenicity | Variant Pathogenicity | Germline Classification |
| G.02 | Drug Response | ClinVar Drug Response* | Germline Classification |
| G.03 | Risk Factor | ClinVar Risk Factor* | Germline Classification |
| G.04 | Protective | ClinVar Protective* | Germline Classification |
| G.05 | Affects | ClinVar Affects* | Germline Classification |
| G.06 | Association | ClinVar Association* | Germline Classification |
| G.07 | Confers Sensitivity | ClinVar Confers Sensitivity* | Germline Classification |
| G.08 | Other | ClinVar Other* | Germline Classification |
| G.09 | Not Provided | ClinVar Not Provided* | Germline Classification |
| O.10 | Oncogenicity | Variant Oncogenicity | Oncogenic Classification |
| S.11 | Clinical Significance | Clinical Significance | Somatic Clinical Impact |
| S.12 | Therapeutic Response | Therapeutic Response | Somatic Clinical Impact |
| S.13 | Diagnostic | Diagnostic | Somatic Clinical Impact |
| S.14 | Prognostic | Prognostic | Somatic Clinical Impact |
Statement Categories (VCV Groups)¶
ClinVar aggregates these 14 statement types into one of 3 VCV-level categories:
- Germline Classification — groups 9 statement types (G.01 through G.09)
- Oncogenic Classification — groups 1 statement type (O.10)
- Somatic Clinical Impact — groups 4 statement types (S.11 through S.14)
About Non-Standard Statements¶
The non-standard statements (marked with *) are defined only in the ClinVar-GKS datasets. These are needed to handle non-standard data in ClinVar. The ClinVar-GKS dataset is a complete representation of ClinVar's XML VCV and RCV releases and must have a way to represent all of the data in ClinVar. ClinVar-GKS does NOT attempt to guess at or map submissions like Risk Factor to the Pathogenicity Risk Allele classifications since the Risk Factor classification was provided years ahead of the recent ability to classify Variant Pathogenicity submissions with established, likely or uncertain risk allele.
Additionally, some of these non-standard statements are no longer accepted as submissions to ClinVar. ClinVar has stopped accepting Risk Factor in favor of the newer Pathogenicity classification terms, as well as other, confers sensitivity, affects and association.
Not Provided statements represent submissions where the submitter provided NO classification. While this may seem counter-intuitive, ClinVar allows this under certain circumstances. Historically, ClinVar needed to allow this for Functional Impact submissions where the submitter was not explicitly classifying the variant.
About Clinical Significance & Somatic Clinical Impact¶
The Clinical Significance statement is the top-level submission for all Somatic Clinical Impact Tier I, II, III & IV submissions. These submissions are different from Pathogenicity or Oncogenicity submissions in that they have a sub-statement tightly coupled with the Tier I & II classified submissions.
All Tier I & II submissions MUST have one of either Therapeutic Response, Diagnostic or Prognostic related submission data associated with them. This is defined in the AMP/ASCO guidelines. However, Tier III & IV do NOT have a combined sub-statement as they represent the Uncertain and Benign/Likely benign Somatic Clinical Impact submissions.
All Somatic Clinical Impact submissions will have a Clinical Significance statement at the top-level. Those that are Tier I & II will have the sub-statement associated through an Evidence Line.