CD16A (FCGR3A) F158V Polymorphism Analysis

Test Code

34493

CPT Codes
81479

Physician Attestation of Informed Consent

This germline genetic test requires physician attestation that patient consent has been received if ordering medical facility is located in AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD or VT or test is performed in MA.

Preferred Specimen

5 mL whole blood collected in an EDTA (lavender-top) tube

Minimum Volume

3 mL whole blood • 20 uL extracted genomic DNA

Other Acceptable Specimens

Whole blood collected in: ACD (yellow-top) tube or sodium heparin (green-top) tube • 100 uL extracted genomic DNA

Instructions

Do not reject extracted DNA sample. Submitted extracted DNA must be extracted from a CLIA approved lab. Normal phlebotomy procedure.
Specimen stability is crucial. Store and ship ambient immediately. Do not freeze.

Transport Temperature

Room temperature

Specimen Stability

Whole blood
Room temperature: 8 days
Refrigerated: 30 days
Frozen: Unacceptable

Extracted DNA
Room temperature: 30 days
Refrigerated: 1 year
Frozen: 2 years

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Clotted • Received frozen

Methodology
Polymerase Chain Reaction (PCR) • SNaPshot

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

A.M. Sets up 2 days a week.

Report Available

Reports in 2 days.

Clinical Significance

CD16A (FCGR3A) F158V Polymorphism Analysis - The CD16A (FCGR3A) gene encodes for an Fc-gamma receptor on human white blood cells which plays an important role in antibody dependent cell-mediated cytotoxicity (ADCC). In cancer patients, differential clinical response to therapeutic monoclonal antibodies has been reported to correlate with the genotype of the CD16A (FCGR3A) gene (PMID: 23286345, PMID: 30374078, PMID 33480963). The different genotypes (V/V, F/V, or F/F) result from a single nucleotide polymorphism, dbSNP rs396991, where a T>G substitution changes phenylalanine (F) to valine (V) at position 158 (P08637 VAR 003960).

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.