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Documentation / Phenotype Matching / Clinical Tiers

Phenotype-Aware Clinical Tiers

The tier answers how strongly a variant should be prioritized for this patient's selected phenotype. It is separate from the variant's ACMG classification and combines phenotype relevance with variant evidence and inheritance context.

Tier Definitions

Tier 1ActionableClinical priority: 80.00-99.99

A rare Pathogenic or Likely Pathogenic variant with a phenotype match of at least 50, subject to inheritance safeguards.

Tier 2Potentially ActionableClinical priority: 60.00-79.99

A rare HIGH or MODERATE impact VUS with a phenotype match of at least 70 and no strong benign evidence, or a Tier 1 candidate demoted because the observed inheritance is insufficient.

IFIncidental FindingClinical priority: 40.00-59.99

A rare Pathogenic or Likely Pathogenic variant whose phenotype match is below the Tier 1 threshold. Review separately from referral-phenotype candidates.

Tier 3UncertainClinical priority: 20.00-39.99

A VUS with moderate phenotype and impact support, or a result retained conservatively by a service safeguard.

Tier 4UnlikelyClinical priority: 0.00-19.99

Benign, Likely Benign, common, or otherwise weakly supported results for the current phenotype.

IF Is Not an ACMG Secondary Findings Determination

The IF group means that a P/LP result does not sufficiently match the referral phenotype. It does not by itself determine reportability, consent scope, or membership in an ACMG Secondary Findings gene list. Apply the appropriate laboratory policy and current professional guidance separately.

Current Assignment Rules

Tier 1 pathway

P/LP, population frequency below 1%, and phenotype match at or above 50. A heterozygous result in an autosomal recessive-only gene is moved to Tier 2 when a second candidate allele is not identified.

Tier 2 pathway

A rare HIGH or MODERATE impact VUS requires phenotype match at or above 70 and must not carry strong benign evidence. Tier 2 is limited to the 15 highest-priority results; overflow is retained in Tier 3 with a recorded reason.

IF pathway

A rare P/LP result below the phenotype threshold is separated from phenotype-relevant Tier 1 results.

Tier 3 pathway

A HIGH or MODERATE impact VUS with phenotype match at or above 30, or another rare VUS with phenotype match at or above 50.

Tier 4 pathway

Benign or Likely Benign classifications, population frequency at or above 1%, reviewed benign ClinVar evidence, and results that do not meet a higher-tier rule.

Additional Safeguards

Inheritance-aware review

Autosomal recessive carrier status can prevent a P/LP result from appearing as immediately actionable. Genes with both dominant and recessive inheritance retain an explanatory note.

Benign evidence

Confirmed benign ClinVar evidence and strong benign ACMG evidence prevent unsupported promotion.

Highly polymorphic regions

HLA-gene results are handled conservatively and do not enter Tier 1 or Tier 2 through this workflow.

Within-tier ordering

Phenotype match, ACMG class, and population rarity order results inside a tier without overriding the tier's clinical safeguards.

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