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Test Code PSYQP Psychotropic Pharmacogenomics Gene Panel, Varies


Necessary Information


Prior Authorization is available, but not required, for this test. If proceeding with the prior authorization process, submit the required form with the specimen.



Specimen Required


Submit only 1 of the following specimens:

 

Specimen Type: Whole blood

Container/Tube: Lavender top (EDTA)

Specimen Volume: 3 mL

Collection Instructions:

1. Invert several times to mix blood.

2. Send whole blood specimen in original tube. Do not aliquot.

Specimen Stability Information: Ambient (preferred) 9 days/Refrigerated 30 days

 

Specimen Type: Saliva

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

Supplies: Saliva Swab Collection Kit (T786)

Specimen Volume: 2 Swabs, use 2 kits for collection

Collection Instructions: Collect and send specimen per kit instructions.

Additional Information: Due to lower concentration of DNA yielded from saliva, testing cannot proceed to reflex testing for CYP2D6 sequencing and will stop after initial testing is complete.

Specimen Stability Information: Ambient 30 days

 

Specimen Type: Extracted DNA

Container/Tube: 2-mL screw top tube

Specimen Volume: 100 mcL (microliters)

Collection Instructions:

1. The preferred volume is 100 mcL at a concentration of 50 ng/mcL.

2. Provide concentration of DNA and volume on tube.

Specimen Stability Information: Frozen (preferred) 1 year/Ambient/Refrigerated


Forms

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. Psychotropic Pharmacogenomics Gene Panel Prior Authorization Ordering Instructions

3. If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

Useful For

Individualizing selection and dosage of medications prescribed for treatment of depression and other psychiatric disorders based on genetic variation

 

Identifying genetic variation in genes known to be associated with response and/or risk of toxicity with psychotropic medications

 

Evaluating patients who have failed therapy with selective serotonin reuptake inhibitors (SSRI)

 

Evaluating patients with treatment-resistant depression

 

Predicting response time to improvement with SSRI

Method Name

Real-Time Polymerase Chain Reaction (RT-PCR) with Allelic Discrimination Analysis/Qualitative Allele-Specific RT-PCR/PCR followed by Sizing Analysis

Reporting Name

Psychotropic PGx Panel, V

Specimen Type

Varies

Specimen Minimum Volume

Blood: 1 mL
Saliva, extracted DNA: see Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Varies

Reject Due To

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

Clinical Information

This panel provides a comprehensive analysis for multiple genes that have strong pharmacogenomic associations with medications used in the treatment of psychiatric disorders, including depression. Each sample is tested for specific variations with known functional impact. Pharmacogenomic data for the following specific variants are reviewed and reported (if present):

-ADRA2A rs1800544

-ANKK1 (DRD2 associated) rs1800497

-CHRNA3 rs1051730

-COMT rs4680

-CYP1A2 *1F, *1K, *6, and *7

-CYP2B6 *4, *5, *6, *7, *8, *9, *11, *12, *13, *14, *15, *16 (also known as *18.002), *18, *19, *20, *22, *26, *27, , *35, *36, and *38

-CYP2C9 *2, *3, *4, *5, *6, *8, *9, *11, *12, *13, *14, *15, *16, *17, *18, *25, *26, *28, *30, *33, and *35

-CYP2C19 *2, *3, *4, *5, *6, *7, *8, *9, *10, *17, and *35

-CYP2D6 *2, *3, *4, *4N, *5, *6, *7, *8, *9, *10, *11, *12, *13, *14A (now known as *114), *14B (now known as *14),*15, *17, *29, *35, *36, *41, *59, *68, and CYP2D6 gene duplication; additional CYP2D6 variants may be detected through the reflex testing process

-CYP3A4 *8, *11, *12, *13, *16, *17, *18, *22, and *26

-CYP3A5 *3, *6, *7, *8, and *9

-DRD2 rs1799978

-EPHX1 rs2234922

-GRIK4 rs1954787

-HLA-A*31:01

-HLA-B*15:02

-HTR2A rs7997012

-HTR2C rs3813929 and rs1414334

-MTHFR rs1801131 and rs1801133

-OPRM1 rs1799971

-SCN1A rs3812718

-SLC6A4 linked polymorphic region (LPR), a 44-base pair promoter insertion/deletion polymorphism

-UGT2B15 rs1902023

 

Based on the results of each assay, a genotype is assigned, and a phenotype is predicted for each gene. Assessment of multiple genes may assist the ordering clinician with personalized drug recommendations, avoidance of adverse drug reactions, and optimization of drug treatment.

Reference Values

An interpretive report will be provided.

Day(s) Performed

Tuesday

Report Available

3 to 14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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

CPT Code Information

81418

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
2D61Z CYP2D6 Full Gene Sequence No, (Bill Only) No
2D62Z CYP2D6 GEN CYP2D6-2D7 Hybrid No, (Bill Only) No
2D63Z CYP2D6 GEN CYP2D7-2D6 Hybrid No, (Bill Only) No
2D64Z CYP2D6 Nonduplicated Gene No, (Bill Only) No
2D65Z CYP2D6 5' Gene DUP/MLT No, (Bill Only) No
2D66Z CYP2D6 3' Gene DUP/MLT No, (Bill Only) No