Dihydropyrimidine Dehydrogenase Genotype, Varies

Test Code

13618

CPT Codes
81232<br>Restricted Client Code

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

Submit only 1 of the following specimens

3 mL whole blood collected in an EDTA (lavender-top) tube, or
3 mL cord blood collected in an EDTA (lavender-top) tube, or
1 swab - saliva collected in a Saliva Collection Kit (T786), or
100 mcl extracted DNA collected in a 2 mL screw-cap Micro Tube with skirted conical base, or 1 mL Matrix tube

Patient Preparation

A previous hematopoietic stem cell transplant from an allogenic donor will interfere with testing. For instructions for testing patients who have a hematopoietic stem cell transplant, call 800-533-1710.

For Saliva:
Patient should not eat, drink, smoke, or chew gum 30 minutes prior to collection.

Minimum Volume

3 mL whole blood • 3 mL cord blood • 1 swab (saliva) • 100 mcL (microliters) extracted DNA

Instructions

Whole Blood, Cord Blood
1. Invert several times to mix blood.
2. Send whole/cord blood specimen in original tube. Do not aliquot.

Saliva:
Collect and send specimen per kit instructions.

Extracted DNA:
1. The preferred volume is at least 100 mcL at a concentration of 75 ng/mcL.
2. Include concentration and volume on tube.

Note:
1. New York Clients-Informed consent is required. Document on the request form or electronic order that a copy is on file. The following documents are available:
-Informed Consent for Genetic Testing (T576)
-Informed Consent for Genetic Testing (Spanish) (T826)
2. If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

Transport Temperature

Room temperature

Specimen Stability

Whole blood and cord blood
Room temperature: 4 days
Refrigerated: 4 days
Frozen: 4 days

Saliva
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable

Extracted DNA
Room temperature: Acceptable
Refrigerated: Acceptable
Frozen: 1 year

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

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability

Methodology
Real-Time RT-PCR

FDA Status
This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

Setup Schedule

Set up: Mon-Fri; Report available: 3-10 days

Reference Range

See Laboratory Report

Clinical Significance

Identifying individuals with genetic variants in DPYD who are at increased risk of toxicity when prescribed 5-fluorouracil (5-FU) or capecitabine chemotherapy treatment.

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.