Variant Reclassification | Fulgent Genetics

Variant Reclassification Policy

When a variant reclassification occurs, Fulgent will proactively review previous cases in which that variant was identified. Fulgent will then issue updated reports for cases where the change in classification may impact clinical management, or, in other words, where the change in classification is expected to be actionable.

This policy will be limited to cases that were run within the 2 years prior to the date of the reclassification. Updated reports are not issued for reclassifications that occur more than 2 years from the original test.

Benign

Likely Benign

Variant of Unknown Significance

Likely Pathogenic

Pathogenic

What Are Actionable Variant Reclassifications?

As new evidence becomes available, the classification of specific variants (changes in the DNA sequence) may change over time. Not all variant reclassifications, however, are expected to be actionable. An actionable change in a variant classification is one that is expected to impact clinical management.

Fulgent's proactive variant reclassification policy focuses on only the changes in variant classification that we consider actionable for diagnostic testing. Whether a reclassification is actionable depends on both the type of reclassification that occurs and the type of variant that is reclassified.

The type of reclassification relates to the change from the original classification to the new classification. For example, a reclassification from likely pathogenic to pathogenic is not considered actionable, whereas a change from VUS to pathogenic is considered actionable.

Types of reclassifications that are considered actionable:

Likely Pathogenic and Pathogenic is actionable with Variant of Unknown Significance.

Likely Pathogenic and Pathogenic is actionable with Likely Benign and Benign.

The type of variant relates to the inheritance pattern of the condition the variant is associated with and the state of the variant in the given patient. For example, a reclassification of a single heterozygous variant in a gene with autosomal recessive inheritance is not considered actionable, whereas a reclassification of a single heterozygous variant in a gene associated with autosomal dominant inheritance is considered actionable.

Types of variants that are considered actionable are those associated with:

Autosomal dominant conditions
Autosomal recessive conditions and the patient is homozygous for the reclassified variant
Autosomal recessive conditions and the patient is compound heterozygous for the reclassified variant and another P/LP
X-linked conditions

Issuance of Updated Reports

Will only be issued to providers that submit samples directly to Fulgent
Will only be issued for cases run within 2 years of the reclassification
Will be issued via original delivery method
Will not be issued for heterozygous carriers of an autosomal recessive only gene
Will not be issued for carrier screening reports

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