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Test ID: PSYQP Psychotropic Pharmacogenomics Gene Panel, Varies


Necessary Information


Psychotropic Pharmacogenomics Gene Panel Prior Authorization Ordering Instructions is required. See Special Instructions.



Specimen Required


Prior Authorization is available for this test. Submit the required form with the specimen.

 

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 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: 1 Swab

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. Include concentration 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 in Special Instructions:

-Informed Consent for Genetic Testing (T576)

-Informed Consent for Genetic Testing-Spanish (T826)

2. Psychotropic Pharmacogenomics Gene Panel Prior Authorization Ordering Instructions is required, see Special 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

Testing Algorithm

If a specimen requires follow-up for CYP2D6, then reflex testing will be performed as appropriate at an additional charge.

 

See CYP2D6 Comprehensive Cascade Testing Algorithm in Special Instructions.

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: 1 swab

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Varies

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, *2A, *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, *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, *5, *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.

Interpretation

An interpretive report will be provided that focuses on medications and genes with published pharmacogenomic practice guidance by the Clinical Pharmacogenetics Implementation Consortium or other professional organizations (1-3), where strong FDA guidance has been issued in drug labels, (4) or where peer-reviewed literature strongly suggests that assessment of pharmacogenomic variants may enhance patient care.(5-8)

 

For additional information regarding pharmacogenomic genes and their associated medications, see Pharmacogenomic Associations Tables in Special Instructions. This resource also includes information regarding enzyme inhibitors and inducers, as well as potential alternate drug choices.

Clinical Reference

1. PharmVar: Pharmacogene Variation Consortium. Updated Mach 3, 2021. Accessed March 22, 2021. Available at www.pharmvar.org/

2. Clinical Pharmacogenetics Implementation Consortium (CPIC). Accessed October 14, 2020. Available at https://cpicpgx.org/

3. Hicks JK, Sangkuhl K, Swen JJ, et al. Clinical Pharmacogenetics Implementation Consortium guideline (CPIC) for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic antidepressants: 2016 update. Clin Pharmacol Ther. 2017;102(1):37-44. doi: 10.1002/cpt.597

4. U.S National Library of Medicine: DailyMed. National Institutes of Health.  Accessed October 14, 2020. Available at https://dailymed.nlm.nih.gov/dailymed/index.cfm

5. Bradley P, Shiekh M, Mehra V, et al: Improved efficacy with targeted pharmacogenetic-guided treatment of patients with depression and anxiety: A randomized clinical trial demonstrating clinical utility. J Psychiatr Res. 2018;96:100-107

6. Brennan FX, Gardner KR, Lombard J, et al: A naturalistic study of the effectiveness of pharmacogenetic testing to guide treatment in psychiatric patients with mood and anxiety disorders. Prim Care Companion CNS Disord. 2015 April 16;17(2). doi: 10.4088/PCC.14m01717

7. Perez V, Salavert A, Espadaler J, et al: Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: results of a randomized, double-blind clinical trial. BMC Psychiatry. 2017 Jul 14;17(1):250

8. Reynolds GP, McGowan OO, Dalton CF: Pharmacogenomics in psychiatry: the relevance of receptor and transporter polymorphisms. Br J Clin Pharmacol. 2014 Apr;77(4):654-672

9. Crews KR, Monte AA, Huddart R, et al: Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2D6, OPRM1, and COMT Genotypes and Select Opioid Therapy. Clin Pharmacol Ther. 2021 Jan 2. doi: 10.1002/cpt.2149. Epub ahead of print

Day(s) Performed

Monday through Thursday

Report Available

3 to 14 days

Test Classification

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.

CPT Code Information

81479

81226

81225

81227

81230

81231

81291

81381 x 2

LOINC Code Information

Test ID Test Order Name Order LOINC Value
PSYQP Psychotropic PGx Panel, V 94753-1

 

Result ID Test Result Name Result LOINC Value
610209 ADRA2A rs1800544 Genotype 94401-7
610210 ANKK1 rs1800497 Genotype 94402-5
610211 CHRNA3 rs1051730 Genotype 94403-3
610212 COMT rs4680 Genotype 74511-7
610213 CYP1A2 Genotype 72884-0
610214 CYP1A2 Phenotype 94254-0
610215 CYP2B6 Genotype 72882-4
610216 CYP2B6 Phenotype 79720-9
610573 CYP2B6 Activity Score In Process
610217 CYP2C19 Genotype 57132-3
610218 CYP2C19 Phenotype 79714-2
610574 CYP2C19 Activity Score In Process
610219 CYP2C9 Genotype 46724-1
610220 CYP2C9 Phenotype 79716-7
610575 CYP2C9 Activity Score In Process
610221 CYP2D6 Genotype 40425-1
610222 CYP2D6 Phenotype 79715-9
610576 CYP2D6 Activity Score In Process
610223 CYP3A4 Genotype 81139-8
610224 CYP3A4 Phenotype 81145-5
610225 CYP3A5 Genotype 81140-6
610226 CYP3A5 Phenotype 79717-5
610227 DRD2 rs1799978 Genotype 94411-6
610228 EPHX1 rs2234922 Genotype 94412-4
610229 GRIK4 rs1954787 Genotype 94413-2
610230 HLA-A*31:01 Genotype 79712-6
610231 HLA-B*15:02 Genotype 57979-7
610232 HTR2A rs7997012 Genotype 93190-7
610233 HTR2C rs3813929 Genotype 93191-5
610234 HTR2C rs1414334 Genotype 93192-3
610235 MTHFR Genotype 94414-0
610236 OPRM1 rs1799971 Genotype 94415-7
610237 SCN1A rs3812718 Genotype 94416-5
610238 SLC6A4 5HTTLPR Genotype 94417-3
610239 UGT2B15 rs1902023 Genotype 94418-1
610240 Interpretation 69047-9
610241 Additional Information 48767-8
610242 Method 85069-3
610243 Disclaimer 62364-5
610244 Reviewed by 18771-6

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
Mayo Clinic Laboratories | Genetics and Pharmacogenomics Catalog Additional Information:

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