M edTr ai t Repor t Sample Report.Detailed... · Columbia, MO 65201 Facility Phone (573) 442-9948 Facility Fax (573) 442-9870 Sample type Buccal Swab Collection date Fri, Jul 19,

PatientJames Doe

GenderM

DOB01/01/1980

Ordering ProviderDoctor One, M.D.

Specimen ID1907.00036

Reported DateMon, Oct 7, 2019

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GeneTrait Laboratories, a division of PTC Laboratories, Inc.300 Portland Street, Columbia, MO 65201

(800) 592-8646 phone • (573) 442-9870 faxCopyright 2019 PTC Laboratories, Inc.

PatientJames DoeGenderMAge at time of report39DOB01/01/1980RaceCaucasian

Ordering provider nameDoctor One, M.D.Ordering provider facilityGeneTrait LabsFacility address300 Portland Suite 300Columbia, MO 65201Facility Phone(573) 442-9948Facility Fax(573) 442-9870

Sample typeBuccal SwabCollection dateFri, Jul 19, 2019Received dateFri, Jul 19, 2019Report issued dateMon, Oct 7, 2019Patient ID26131

James Doe's detailed genetic test results are outlined below.

Alert Gene Tested Alleles Genotype Phenotype

CYP2D6*1, *2, *3, *4, *4J, *4K, *4M, *5, *6, *6C, *7, *8, *9, *10,*12, *14, *14B, *17, *29, *34, *35, *39, *41, *64, *65,*69, *70, XN

*4/*5 PM

CYP2C19 *1, *2, *3, *4, *4B, *5, *6, *8, *9, *10, *17 *1/*2 IM

CYP2C9 *1, *2, *3, *5, *6, *8, *11 *1/*1 EM

CYP3A4/5 EM

CYP3A4 *1, *1B, *2, *3, *12, *17, *22 *1/*1

CYP3A5 *1, *1D, *2, *3A, *3B, *3C, *6, *7, *9 *3A/*3A

VKORC1 -1639 G>A G/G Normal Sensitivity to Warfarin

SLCO1B1 *1, *5 *1/*1 EM

ATM rs11212617 A/C Increased Response

TPMT *1, *2, *3A, *3B, *3C *1/*1 EM

Factor V Leiden 1691G>A A/A Increased Risk

Prothrombin (Factor II) G20210A G/G Normal Risk

MTHFR Increased Risk

MTHFR A1298C A1298C A/C

MTHFR C677T C677T T/T

ApoE E2, E3, E4 E3/E3 Normal Risk

COMT VAL, MET VAL/MET Intermediate Activity

Results electronically approved and reported on Fri, Jul 19, 2019 by M. Beckwith

Phenotype De�nition (as used in this report)PM Poor Metabolizer Drug metabolism through the tested enzymatic pathway(s) is extremely reduced.IM Intermediate Metabolizer Drug metabolism through the tested enzymatic pathway(s) is slower than normal.EM/IM Reduced Metabolizer Drug metabolism through the tested enzymatic pathway(s) is slower than normal, but may not have clinical impact.EM Extensive Metabolizer Drug metabolism through the tested enzymatic pathway(s) is normal.RM Rapid Metabolizer Drug metabolism through the tested enzymatic pathway(s) is slightly faster than normal.UM Ultra Metabolizer Drug metabolism through the tested enzymatic pathway(s) is faster than normal.

MedTrait® Report

Genetic Summary

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Patient Provider Specimen

PatientJames Doe

GenderM

DOB01/01/1980




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Keep this card with you at all times for quick reference to your pharmacogenetic summary. Cut along dotted lines and fold.

All testing is completed by PTC Laboratories, doing business as GeneTrait® Laboratories. This test was developed and its performance characteristics determined by PTC Laboratories. It hasnot been cleared or approved by the U.S. Food and Drug Administration. Tests are completed on a Life Technologies QuantStudio 12K Flex RT-PCR System with OpenArray Block and thislaboratory has veri�ed the 99.7% genotyping accuracy of the testing platform. All genotyping is performed in duplicate. The assay is not designed to detect any genetic variants not speci�callylisted in this report.CLIA: 26D2056029

Laboratory Director: Charlotte Phillips, Ph.D.

Wallet Card

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Personal Genetic Summary

James Doe 01/01/1980

Alert Gene Genotype Phenotype

CYP2D6 *4/*5 PM


Factor V Leiden A/A Increased Risk

CYP2C19 *1/*2 IM

COMT VAL/MET Intermediate Activity

ATM A/C Increased Response

ApoE E3/E3 Normal Risk

Alert Gene Genotype Phenotype

CYP2C9 *1/*1 EM

Prothrombin (Factor II) G/G Normal Risk

CYP3A4/5 EM

TPMT *1/*1 EM

VKORC1 G/G Normal Sensitivity toWarfarin

SLCO1B1 *1/*1 EM

PhenotypeDe�nition (as used on this card)

PMPoor MetabolizerDrug metabolism through the tested enzymatic pathway(s) is extremely reduced.

IMIntermediateMetabolizerDrug metabolism through the tested enzymatic pathway(s) is slower than normal.

EM/IMReduced MetabolizerDrug metabolism through the tested enzymatic pathway(s) is slower than normal, but may not haveclinical impact.

EMExtensiveMetabolizerDrug metabolism through the tested enzymatic pathway(s) is normal.

RMRapid MetabolizerDrug metabolism through the tested enzymatic pathway(s) is slightly faster than normal.

UMUltra MetabolizerDrug metabolism through the tested enzymatic pathway(s) is faster than normal.

Information

This wallet card provides genetic information related to this patient's speci�c medicationmetabolism. This data is intended to be used as a reference for a healthcare provider, and not areplacement for a complete MedTrait pharmacogenetic assisted medication management report.Please contact GeneTrait Laboratories (genetrait.com or 800-592-8646) for a full copy of theMedTrait report. Healthcare providers can also access this information, and additional interactivemedication management tools, at medtrait.net (patient ID 26131, and specimen ID of1907.00036).

AlertGeneGenotypePhenotype

Notes:About This Report

PatientJames Doe

GenderM

DOB01/01/1980




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PatientJames DoeGenderMAge at time of report39DOB01/01/1980RaceCaucasian

Ordering provider nameDoctor One, M.D.Ordering provider facilityGeneTrait LabsFacility address300 Portland Suite 300Columbia, MO 65201Facility Phone(573) 442-9948Facility Fax(573) 442-9870

Sample typeBuccal SwabCollection dateFri, Jul 19, 2019Received dateFri, Jul 19, 2019Report issued dateMon, Oct 7, 2019Patient ID26131

Section PageCurrent Medication Report 2Duplicate Therapy Summary 3Current Medication Summary 3Risk Factor Assessment 4Risk Factor Guidance 4

Section PageComprehensive Genetic Drug Panel 5Medication Guidance 10Genetic Summary 18This Report Includes 19Legend 20

Based on the �ndings within this report, the following information should be closely reviewed.

Duplicate Therapy Considerations2 or more medications are indicated as prescribed for similar therapeutic intent. Please review the Duplicate Therapy section forfurther details.

Medication Considerations2 medications are indicated as higher risk / higher bene�t for this patient, including risperiDONE and SEROquel. Plavix is indicatedas lower risk / lower bene�t for this patient. Please review the Current Medication Report and Current Medication Summarysections for further details.

Genetic Considerations6 genetic groups have variants, including CYP2D6 (PM), CYP2C19 (IM), ATM (Increased Response), Factor V Leiden (IncreasedRisk), MTHFR (Increased Risk), and COMT (Intermediate Activity). Please review the Genetic Summary section for further details.

Risk Factor ConsiderationsThis patient has elevated risk of Hyperhomocysteinemia and Thrombosis due to genetic factors. Please review the Risk FactorAssessment section for further details.

MedTrait® Provider Tool

Contents

Highlights

Patient Provider Specimen

FOR HEALT

HCARE PROVIDER USE

PatientJames Doe

GenderM

DOB01/01/1980




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Legend:

Each of James Doe's current medications are classi�ed in one of the four quadrants displayed below.Higher Total Alert Score indicates greater risk of adverse drug reactions or non-e�cacy, based on drug interactions, genetic interactions and base risk.

Maximum Alert Score = 25 (up to 10 maximum drug interaction alert, 10 genetic interaction alert, 5 base risk).

Base Drug Risk Drug Interaction Genetic Interaction Lifestyle Interaction Genetic Con�dence Level Not Genetically Evaluated

Current Medication Report

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LOW

ER R

ISK

HIG

HER

RIS

K⟶

HIGHER BENEFIT LOWER BENEFIT⟶

risperiDONE (Risperidone)

total alert score: 5

SEROquel (Quetiapine Fumarate)


rOPINIRole HCl (Ropinirole Hydrochloride)


raNITIdine HCl (Ranitidine HCl)


Plavix (Clopidogrel Bisulfate)


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PatientJames Doe

GenderM

DOB01/01/1980




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Legend:

Detailed guidance on medications which may have similar or additive clinical impact.

Duplicate risperiDONE Oral Tablet 2 MG and SEROquel Oral Tablet 100 MG are in the ORAL ANTIPSYCHOTICS class and mayrepresent a therapeutic duplication.

Detailed guidance on each of James Doe's current medications with identi�ed alerts.Higher Total Alert Score indicates greater risk of adverse drug reactions or non-e�cacy, based on drug interactions, genetic interactions and base risk.

Maximum Alert Score = 25 (up to 10 maximum drug interaction alert, 10 genetic interaction alert, 5 base risk).

risperiDONE (Risperidone) Total Alert Score: 5 3 1 1

Interactions Additive QT interval prolongation may occur during coadministration of moderate-risk QT-prolonging agents,quetiapine and risperiDONE Oral Tablet 2 MG. (ADR Risk Score: 3/5)

Genetics

Drug metabolism is decreased resulting in higher plasma concentrations of risperidone and lower concentrations ofthe metabolite 9-hydroxyrisperidone, both active compounds. [28, 49, 51, 52, 53, 259] Consider an alternative drugnot primarily metabolized by CYP2D6. Alternatively follow standard dosing recommendations and titrate toresponse while monitoring for e�cacy/ADRs (28). A recent study demonstrated a statistically signi�cant correlationbetween CYP2D6 PMs and increased rates of ADRs in children and adolescents (259) but was not seen in olderstudies (49,52). (ADR Risk Score: 1/5)

SEROquel (Quetiapine Fumarate) Total Alert Score: 4 3 0 1

Interactions Additive QT interval prolongation may occur during coadministration of moderate-risk QT-prolonging agents,quetiapine and risperiDONE Oral Tablet 2 MG. (ADR Risk Score: 3/5)

Plavix (Clopidogrel Bisulfate) Total Alert Score: 3 0 2 1

GeneticsClopidogrel is a prodrug that is converted to its active form by CYP2C19. Drug metabolism is mildly decreasedresulting in reduced platelet inhibition and diminished therapeutic e�cacy. [28, 41] Consider an alternative drug notprimarily metabolized by CYP2C19. (E�cacy Reduction Score: 2/5)

Lifestyle Pharmacologic effects of Plavix Oral Tablet 75 MG may be decreased by consumption of grapefruit juice.

raNITIdine HCl (Ranitidine HCl) Total Alert Score: 0 0 0 0

Lifestyle Plasma concentrations and pharmacologic effects of Alcoholic Beverages may be increased by raNITIdine HCl OralTablet 75 MG. Clinical signi�cance is not known.

Genetic Con�dence Level Drug Interaction Genetic Interaction Base Drug Risk Lower Risk / Lower Bene�t Lower Risk / Higher Bene�t Higher Risk / Higher Bene�t Not Genetically Evaluated

Duplicate Therapy Summary

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Current Medication Summary

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FOR HEALT

HCARE PROVIDER USE

PatientJames Doe

GenderM

DOB01/01/1980




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Legend:

James Doe's genetic risk factor assessment details are outlined below.

Normal Risk Increased Risk Warning

Cardiovascular Disease Hyperhomocysteinemia Thrombosis

Cardiovascular DiseaseRisk Level

Normal RiskGenes EvaluatedApoE Normal Risk

Statins, a low fat diet, and moderate alcohol usage are expected to be bene�cial therapies in lowering LDL in individuals with this genotype. [3]

HyperhomocysteinemiaRisk Level

Increased RiskGenes EvaluatedMTHFR A1298C Normal Risk • MTHFR C677T Increased Risk

This patient is homozygous for the MTHFR 677T allele and heterozygous for the MTHFR 1298C allele.

Individuals with these genotypes have a signi�cantly greater risk of hyperhomocysteinemia than individuals without the variant alleles. [18, 25]

ThrombosisRisk Level

WarningGenes EvaluatedFactor V Leiden Increased Risk • MTHFR A1298C Normal Risk • MTHFR C677T Increased Risk • Prothrombin (Factor II) Normal Risk

Consultation with a medical geneticist, genetic counselor or hematologist is recommended for further guidance.

This patient has two high risk alleles for venous thrombosis. Individuals who are homozygous for (have two copies of) the Factor V Leiden variantallele have approximately 80 times greater risk of venous thrombosis than individuals without the variant alleles. [254] Variant alleles wereidenti�ed at three locations within the MTHFR A1298C and MTHFR C677T loci. Individuals with these variant alleles have a signi�cant reduction ofnormal MTHFR enzyme activity and are at increased risk of hyperhomocysteinemia. Evidence suggests that these variants alone may not be asigni�cant risk factor for thrombosis, but in conjunction with a Factor V Leiden or Factor II variant allele, these MTHFR variants may further increasethe risk for thrombosis. [101]

Genetic Con�dence Level

Risk Factor Assessment

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Risk Factor Guidance

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FOR HEALT

HCARE PROVIDER USE

PatientJames Doe

GenderM

DOB01/01/1980




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Legend:

James Doe's Comprehensive Genetic Drug Panel medication assessment details are outlined below.

Standard Precautions Information/Caution Consider Alternatives

Irbesartan

Ranolazine

Warfarin

Clopidogrel

Carvedilol Metoprolol

Flecainide

Mexiletine

Propafenone

Atorvastatin

Pravastatin

Rosuvastatin

Simvastatin

Metformin

Glimepiride

Tolbutamide

Genetic Con�dence Level Higher Risk / Higher Bene�t Lower Risk / Lower Bene�t Lower Risk / Higher Bene�t

Comprehensive Genetic Drug Panel

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Cardiovascular • Angiotensin II Receptor Antagonist

Cardiovascular • Antianginal

Cardiovascular • Anticoagulant

Cardiovascular • Antiplatelet

Cardiovascular • Beta Blocker

Cardiovascular • Sodium Channel Blocker

Cardiovascular • Statin

Diabetes • Biguanide

Diabetes • Sulfonylureas

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PatientJames Doe

GenderM

DOB01/01/1980




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Legend:


Ondansetron

Palonosetron

Metoclopramide

Dexlansoprazole

Esomeprazole

Lansoprazole

Omeprazole

Pantoprazole

Eliglustat

Lesinurad

Avatrombopag

Eltrombopag

Lusutrombopag

Tetrabenazine

Azathioprine

Voriconazole

Donepezil


Gastrointestinal • 5-HT3 Antagonist

Gastrointestinal • Antiemetic

Gastrointestinal • Proton Pump Inhibitor

Gaucher's Disease • Endocrine-Metabolic

Gout • URAT1 Inhibitor

Hematology • Thrombopoietin Receptor Agonist

Huntington’s Disease • Vesicular Monoamine Transporter-2 Inhibitor

Immunosuppressant • IMDH Inhibitor

Infectious Diseases • Antifungal

Mental Health - Dementia • AntidementiaFOR HEALT

HCARE PROVIDER USE

PatientJames Doe

GenderM

DOB01/01/1980




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Legend:


Galantamine

Maprotiline

Mirtazapine

Aripiprazole

Nefazodone

Vortioxetine

Duloxetine Venlafaxine

Citalopram Paroxetine

Escitalopram

Fluoxetine

Fluvoxamine

Sertraline

Amitriptyline

Amoxapine

Clomipramine

Desipramine

Doxepin

Imipramine

Nortriptyline


Mental Health - Depression • Antidepressant - Other

Mental Health - Depression • Atypical Antipsychotic

Mental Health - Depression • Serotonin Modulator

Mental Health - Depression • SNRI

Mental Health - Depression • SSRI

Mental Health - Depression • Tricyclic Antidepressant

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PatientJames Doe

GenderM

DOB01/01/1980




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Legend:


Protriptyline

Trimipramine

Aripiprazole

Clozapine

Iloperidone

Risperidone

Haloperidol Thioridazine

Pimozide

Fosphenytoin Brivaracetam

Lacosamide

Phenytoin

Clobazam

Ondansetron

Palonosetron

Tamoxifen

Mercaptopurine

Thioguanine

Carisoprodol


Mental Health - Psychotic • Atypical Antipsychotic

Mental Health - Psychotic • Typical Antipsychotic

Mental Health - Seizure • Anticonvulsant

Mental Health - Seizure • Benzodiazepine

Oncology • 5-HT3 Antagonist

Oncology • Antiestrogen

Oncology • Antimetabolites

Pain Management • Muscle RelaxantFOR HEALT

HCARE PROVIDER USE

PatientJames Doe

GenderM

DOB01/01/1980




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Legend:


Celecoxib

Flurbiprofen

Ibuprofen

Meloxicam

Piroxicam

Morphine Oxycodone Codeine

Hydrocodone

Tramadol

Cevimeline

Tamsulosin


Pain Management • NSAID

Pain Management • Opioid

Sjogren's Syndrome • Cholinergic Agonist

Urologicals • Alpha-Blocker

FOR HEALT

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PatientJames Doe

GenderM

DOB01/01/1980




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AmitriptylineTricyclic Antidepressant

Genes EvaluatedCYP2C19 IM • CYP2D6 PM

Precaution LevelConsider Alternatives

ConcernADR

Guidance

Consider an alternative drug not primarily metabolized by CYP2D6 enzyme (28,39). Alternatively consider a 50%reduction of standard dosing recommendations and titrate to response while monitoring for e�cacy/ADRs (39).

Drug metabolism is decreased resulting in higher plasma concentrations and the potential for elevated risk of ADRs.[28, 39]

AmoxapineTricyclic Antidepressant

Genes EvaluatedCYP2D6 PM


ConcernADR

Guidance

Pharmacogenomic data is not well documented and speci�c dosing recommendations are not available. Inferredrecommendations for patients with reduced CYP2D6 function using tricyclic antidepressants can be applied asfollows; consider an alternative drug not primarily metabolized by CYP2D6 enzyme. Alternatively consider a 50%reduction of standard dosing recommendations and titrate to response while monitoring for e�cacy/ADRs.

Drug metabolism is decreased resulting in higher plasma concentrations and the potential for elevated risk of ADRs.[39]

AripiprazoleAtypical Antipsychotic


Precaution LevelInformation/Caution

ConcernADR

Guidance

For Abilify oral: administer 50% of usual starting dosage and titrate to response (maximum dose of 10mg/day).When coadministered with a strong CYP3A4 inhibitor for = 2 weeks: administer 25% of the usual dosage (64).

For Abilify Maintena monthly injection: starting dose 300mg once monthly. When coadministered with a strongCYP3A4 inhibitor for = 2 weeks: administer 200mg monthly (122).

For Aristada injection: When coadministered with a strong CYP3A4 OR CYP2D6 inhibitor for = 2 weeks: administer441mg monthly (121).

Drug metabolism is decreased resulting in higher plasma concentrations and elevated risk of ADRs. [64, 121, 122]

AvatrombopagThrombopoietin Receptor Agonist

Genes EvaluatedFactor V Leiden Increased Risk • Prothrombin (Factor II) Normal Risk


ConcernADR

Guidance

Thrombopoietin receptor agonists such as avatrombopag should be used with caution in patients at increased riskfor thromboembolic events, including those with Factor V Leiden variations. Studies to date have not evaluated theeffects of using TRAs in patients with this variant gene and dosage adjustments are not currently available.

This patient has variations in the Factor V Leiden gene that result in an approximately 80 times greater risk ofvenous thrombosis than individuals without the variant alleles. [250, 254]

BrivaracetamAnticonvulsant

Genes EvaluatedCYP2C19 IM


ConcernADR

Guidance

Follow standard recommended dosage. Dose reductions may be necessary due to reduced metabolism. Monitor fore�cacy/ADRs.

Brivaracetam is metabolized by hydrolysis and to a lesser extent by CYP2C19. CYP2C19 IMs displayed a 22%increase in brivaracetam plasma concentrations however the clinical signi�cance of this increase is unknown anddosage adjustment recommendations are unavailable. Monitor for ADRs. [61]

CarisoprodolMuscle Relaxant



ConcernADR

Guidance

Lower doses may be necessary to avoid potential risks of carisoprodol related impairing effects such as drowsiness,sedation, and hypotension.

Drug metabolism is mildly decreased. Carisoprodol is converted to the active metabolite meprobamate. The ratio ofcarisoprodol : meprobamate may be increased resulting in an elevated risk of carisoprodol related ADRs. [116, 117,118]

Medication Guidance

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FOR HEALT

HCARE PROVIDER USE

PatientJames Doe

GenderM

DOB01/01/1980




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CarvedilolBeta Blocker



ConcernADR

Guidance

Follow standard recommended dosage and titration instructions. Monitor for e�cacy/ADRs.

Although CYP2D6 function is decreased, therapeutic impact is minimal and should not necessitate a dosageadjustment. Carvedilol is a racemic mixture that is metabolized by many enzymes, including CYP2D6 whichconverts carvedilol to an active metabolite that is 13 times more potent than the parent compound for betablockade. The parent R(+) enantiomer has alpha adrenergic blockade activity that can lead to dizziness duringtitration (160). One study indicated a non-statistically signi�cant trend towards higher maintenance doses ofcarvedilol in systolic heart failure patients (112). [28, 112, 160, 161, 163]

CevimelineCholinergic Agonist



ConcernADR

GuidanceUse with caution in CYP2D6 poor metabolizers. Speci�c dosing recommendations are not available.


CitalopramSSRI



ConcernADR

Guidance

Follow standard recommended dosage. Monitor for increased risk of ADRs.

CYP2C19 enzyme function is decreased resulting in higher plasma concentration, longer half life and the potentialfor elevated risk of ADRs. A dosage adjustment is not expected to be necessary, however, use caution when adjustingdose upward. [35]

ClomipramineTricyclic Antidepressant



ConcernADR

Guidance

Consider an alternative drug not primarily metabolized by CYP2D6 enzyme (39). Alternatively consider a 50%reduction of standard dosing recommendations and titrate to response while monitoring for e�cacy/ADRs (39).


ClopidogrelAntiplatelet



ConcernE�cacy

GuidanceConsider an alternative drug not primarily metabolized by CYP2C19.

Clopidogrel is a prodrug that is converted to its active form by CYP2C19. Drug metabolism is mildly decreasedresulting in reduced platelet inhibition and diminished therapeutic e�cacy. [28, 41]

ClozapineAtypical Antipsychotic



ConcernADR

Guidance

The manufacturer package insert states that dose reductions may be necessary for CYP2D6 poor metabolizers (65).However multiple studies have failed to demonstrate a signi�cant correlation between CYP2D6 poor metabolizersand altered clozapine serum concentrations or response compared to other CYP2D6 phenotypes (165,166,167).Speci�c dosing recommendations are not available. Consider an initial starting dose reduction with standardtitrations while closely monitoring for e�cacy/ADRs.

CYP2D6 is a secondary metabolic pathway for clozapine with CYP1A2 being the primary pathway. Drug metabolismis decreased resulting in the potential for higher plasma concentrations and elevated risk of ADRs. [65, 165, 166, 167]

CodeineOpioid



ConcernE�cacy

Guidance

Consider an alternative drug not primarily metabolized by CYP2D6 (8,28,44) or closely monitor for poor response(28).

Codeine is a prodrug with active metabolites including morphine. Drug metabolism is decreased resulting in apotential for poor response. [8, 28, 44]

FOR HEALT

HCARE PROVIDER USE

PatientJames Doe

GenderM

DOB01/01/1980




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DesipramineTricyclic Antidepressant



ConcernADR

GuidanceConsider an alternative drug not primarily metabolized by CYP2D6 enzyme. Alternatively consider a 50% reductionof standard dosing recommendations and titrate to response while monitoring for e�cacy/ADRs.

Drug metabolism is decreased resulting in higher plasma concentrations and elevated risk of ADRs. [39]

DonepezilAntidementia



ConcernADR

Guidance

Follow standard recommended dosage. The manufacturer does not provide dosing guidance for PMs. Monitor fore�cacy and closely for tolerability as patient is at increased risk for ADRs due to higher donepezil levels (175).

Alternatively, a reduction of the standard dose may increase tolerability (176).

Drug metabolism of donepezil is decreased resulting in higher plasma concentrations and the potential for elevatedrisk of ADRs. PMs showed a 31.5 to 32% decreased clearance compared to EMs. [175, 176]

DoxepinTricyclic Antidepressant



ConcernADR

Guidance

Consider an alternative drug not primarily metabolized by CYP2D6 enzyme (28,39). Alternatively consider a 50%reduction of standard dosing recommendations and titrate to response while monitoring for e�cacy/ADRs (39).


DuloxetineSNRI



ConcernADR

Guidance

Consider a dose titration to standard dosing recommendations. Alternatively select a drug not primarily metabolizedby CYP2D6 enzyme. Monitor for e�cacy and closely for tolerability as patient is at increased risk for ADRs due tohigher duloxetine levels.

Drug metabolism is decreased resulting in higher plasma concentrations and elevated risk of ADRs. [37, 38]

EliglustatEndocrine-Metabolic



ConcernADR

Guidance

Follow standard recommended dosage of 84mg ONCE daily. Use is contraindicated in patients taking strong CYP3Ainhibitors. Use is not recommended in patients taking weak to moderate CYP3A inhibitors. Use is not recommendedwith a CYP3A inducer. Monitor for e�cacy/ADRs.


EltrombopagThrombopoietin Receptor Agonist



ConcernADR

Guidance

Thrombopoietin receptor agonists such as eltrombopag should be used with caution in patients at increased risk forthromboembolic events, including those with Factor V Leiden variations. Studies to date have not evaluated theeffects of using TRAs in patients with this variant gene and dosage adjustments are not currently available.


EscitalopramSSRI



ConcernADR

Guidance


CYP2C19 enzyme function is decreased resulting in higher plasma concentration, longer half life and the potentialfor elevated risk of ADRs. A dosage adjustment is not expected to be necessary, however, use caution when adjustingdose upward. [35]FOR H

EALTHCARE PROVID

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PatientJames Doe

GenderM

DOB01/01/1980




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FlecainideSodium Channel Blocker



ConcernADR

GuidanceConsider a 50% reduction of standard dosing recommendations and titrate to response while monitoring ECG,plasma concentration, and for e�cacy/ADRs.


FluoxetineSSRI



ConcernADR

Guidance

Follow standard recommended dosage and monitor for e�cacy/ADRs. Alternatively, select a drug not primarilymetabolized by CYP2D6 enzyme. Use with caution in patients with congenital long QT syndrome and in situationsthat may prolong QT due to elevated �uoxetine levels such as hepatic impairment, use of CYP2D6 inhibitors, poormetabolizer status, or use of other highly protein-bound drugs.

Drug metabolism may be decreased resulting in higher plasma concentrations and a potential elevated risk of ADRs.The clinical signi�cance of this is unknown as �uoxetine is metabolized to nor�uoxetine, both molecules are thoughtto be active therapeutic compounds. The impact of differing ratios of �uoxetine to nor�uoxetine is unknown. Thusgene-based dosing is not currently available. [35]

FluvoxamineSSRI



ConcernADR

GuidanceConsider a 25 to 50% reduction of standard dosing recommendations and titrate to response while monitoring fore�cacy/ADRs. Alternatively, select a drug not primarily metabolized by CYP2D6 enzyme.


GalantamineAntidementia



ConcernADR

Guidance

Follow standard recommended dosage. Titrate carefully to effect based on tolerability due to increased risk ofoverexposure.

Drug metabolism is decreased resulting in higher plasma concentrations and elevated risk of ADRs. Poormetabolizers exhibited a 50% higher exposure compared to extensive metabolizers. [59]

HaloperidolTypical Antipsychotic



ConcernADR

GuidanceConsider a 50% reduction of standard dosing recommendations and titrate to response while monitoring fore�cacy/ADRs or select an alternative drug.


HydrocodoneOpioid



ConcernE�cacy

Guidance

Consider an alternative drug not primarily metabolized by CYP2D6. If hydrocodone is used higher doses may benecessary to achieve adequate analgesia.

Hydrocodone is converted to the more potent active metabolite hydromorphone by CYP2D6. Drug metabolism isdecreased resulting in the potential for diminished pain relief, therapeutic failure and an increased risk of adversereactions from hydrocodone. [8, 184, 185, 186]

IloperidoneAtypical Antipsychotic



ConcernADR

Guidance

Follow standard recommended titration guidelines with a target dose reduction of 50%. Monitor for e�cacy/ADRsincluding orthostatic hypotension and QTc prolongation.


FOR HEALT

HCARE PROVIDER USE

PatientJames Doe

GenderM

DOB01/01/1980




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ImipramineTricyclic Antidepressant



ConcernADR

Guidance

Consider an alternative drug not primarily metabolized by CYP2D6 enzyme. Alternatively consider a 50% (39) to 70%(28) reduction of standard dosing recommendations and titrate to response while monitoring for e�cacy/ADRs (39).


LusutrombopagThrombopoietin Receptor Agonist



ConcernADR

Guidance

Thrombopoietin receptor agonists such as lusutrombopag should be used with caution in patients at increased riskfor thromboembolic events, including those with Factor V Leiden variations. Studies to date have not evaluated theeffects of using TRAs in patients with this variant gene and dosage adjustments are not currently available.


MaprotilineAntidepressant - Other



ConcernADR

Guidance



MetoclopramideAntiemetic



ConcernADR

Guidance

Reduce dose based on diagnosis. Max 20mg/day (5mg QID) for acute and recurrent diabetic gastroparesis. Max30mg/day (5mg QID or 10mg TID) for gastroesophageal re�ux (125).

Drug metabolism is decreased resulting in higher plasma concentrations and elevated risk of ADRs includingdystonic reactions and tardive dyskinesia. [125, 126, 127, 128]

MetoprololBeta Blocker



ConcernADR

Guidance

Follow standard recommended dosage and titrate to response or select a different drug. Alternative DPWGrecommendations for heart failure; reduce starting dose by 75% or select a different drug. Monitor for e�cacy/ADRs.

Drug metabolism is decreased resulting in higher plasma concentrations and elevated risk of ADRs. Proper titrationshould negate potential ADR risks. [28, 110, 111, 112, 113, 114, 115]

MexiletineSodium Channel Blocker



ConcernADR

Guidance

Pharmacogenomic data is not well documented and speci�c dosing recommendations are not available. Consider alower starting dose and titrate to response while monitoring for e�cacy/ADRs, serum mexiletine concentrations,ECG, and LFTs as indicated.


MirtazapineAntidepressant - Other



ConcernADR

Guidance

Follow standard recommended dosage. Monitor for e�cacy and closely for tolerability as patient is at increased riskfor ADRs due to higher mirtazapine levels.

Drug metabolism is decreased resulting in higher plasma concentrations and the potential for elevated risk of ADRs,particularly sedation. [216, 217, 218]

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NefazodoneSerotonin Modulator



ConcernADR

Guidance

Follow standard recommended dosage. Monitor for e�cacy and closely for tolerability as patient is at increased riskfor ADRs due to higher active metabolite levels.

Nefazodone is converted to several pharmacologically active metabolites. The minor metabolitemetachlorophenylpiperazine is cleared by CYP2D6. Although CYP2D6 enzyme function is decreased, therapeuticimpact is minimal and should not necessitate a dosage adjustment. Monitor closely for ADRs as metaboliteclearance is decreased. [46]

NortriptylineTricyclic Antidepressant



ConcernADR

GuidanceConsider an alternative drug not primarily metabolized by CYP2D6 enzyme (39). Alternatively consider a 50%reduction (39) to 60% reduction (28) of standard dosing recommendations while monitoring for e�cacy/ADRs.


OxycodoneOpioid



ConcernE�cacy

Guidance

Follow standard recommended dosage. Monitor for e�cacy/ADRs. Higher doses may be necessary for satisfactoryanalgesia and achieved through typical dose titrations (104). Alternatively, select a drug not metabolized byCYP2D6.

Although CYP2D6 function is decreased, therapeutic impact is minimal and should not necessitate a dosageadjustment. CYP2D6 plays a minor role in oxycodone metabolism. Plasma concentrations of the more potent butminor metabolite oxymorphone may be decreased; however the analgesic e�cacy and side effect risks do notsigni�cantly differ among the various CYP2D6 phenotypes (102, 103). [102, 103, 104, 105]

ParoxetineSSRI



ConcernADR

GuidanceConsider an alternative drug not primarily metabolized by CYP2D6 or consider a starting dose reduction of 50% andtitrate to response while monitoring for e�cacy/ADRs.


PimozideTypical Antipsychotic



ConcernADR

Guidance

Consider a dose titration to a maximum of 4mg/day and monitor for e�cacy/ADRs (particularly for cardiac sideeffects including QTc prolongation with ECG monitoring). Dose should not be increased earlier than 14 days.Alternatively select a drug not primarily metabolized by the CYP2D6 enzyme.

Drug metabolism is decreased resulting in higher plasma concentrations, a prolonged half-life and elevated risk ofADRs including QTc prolongation. Titrate dose cautiously, may take 2 weeks to reach steady state. [131, 132]

PropafenoneSodium Channel Blocker



ConcernADR

GuidanceConsider a 70% reduction of standard dosing recommendations and titrate to response while monitoring ECG,plasma concentration, and for e�cacy/ADRs. Alternatively select a different drug.


ProtriptylineTricyclic Antidepressant



ConcernADR

Guidance



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Page16 of 20



RanolazineAntianginal



ConcernADR

Guidance

Follow standard recommended dosage. Monitor for e�cacy and closely for tolerability as patient is at increased riskfor ADRs due to higher ranolazine levels.

Use extra caution when titrating dose up in patients with hepatic impairment, mild to moderate renal impairment,elderly, patients with low weight, and patients with moderate to severe CHF.

Ranolazine is primarily metabolized by CYP3A, and to a lesser extent by CYP2D6. Drug metabolism is decreasedresulting in higher plasma concentrations and elevated risk of ADRs.

At the 500mg twice daily dose, ranolazine plasma levels are 1.2 fold higher in patients that are poor CYP2D6metabolizers, or when ranolazine is given in combination with a strong CYP2D6 inhibitor. [208]

RisperidoneAtypical Antipsychotic



ConcernADR

Guidance

Consider an alternative drug not primarily metabolized by CYP2D6. Alternatively follow standard dosingrecommendations and titrate to response while monitoring for e�cacy/ADRs (28). A recent study demonstrated astatistically signi�cant correlation between CYP2D6 PMs and increased rates of ADRs in children and adolescents(259) but was not seen in older studies (49,52).

Drug metabolism is decreased resulting in higher plasma concentrations of risperidone and lower concentrations ofthe metabolite 9-hydroxyrisperidone, both active compounds. [28, 49, 51, 52, 53, 259]

SertralineSSRI



ConcernADR

Guidance


CYP2C19 enzyme function is decreased resulting in higher plasma concentration, longer half life and the potentialfor elevated risk of ADRs. A dosage adjustment is not expected to be necessary, however, use caution when adjustingdose upward. [28, 35]

TamoxifenAntiestrogen



ConcernE�cacy

Guidance

Consider an aromatase inhibitor. Alternatively, if a contraindication exists to taking an AI, consider a highertamoxifen dose of 40mg and monitor for e�cacy/ADRs (164). Minimum endoxifen concentrations of 5.97 ng/mL(16 nM) have been suggested to reach e�cacy (158). Tamoxifen dose increases to 40mg does not completelynormalize endoxifen concentrations in CYP2D6 poor metabolizers.

Tamoxifen is a prodrug that is converted to its active form endoxifen by CYP2D6. Drug metabolism is decreasedresulting in diminished therapeutic e�cacy and the increased risk for breast cancer recurrence. Short term studiesindicate good tolerability and e�cacy with gene based dose increases; however, the long term e�cacy andtolerability has not been evaluated. If possible avoid concomitant weak to strong CYP2D6 inhibitors. [28, 158, 164]

TamsulosinAlpha-Blocker



ConcernADR

GuidanceTamsulosin should be used with caution in CYP2D6 poor metabolizers, especially at doses higher than 0.4mg.


TetrabenazineVesicular Monoamine Transporter-2 Inhibitor



ConcernADR

Guidance

The initial titration schedule is 12.5mg daily for one week, 12.5mg twice daily for one week, increased by 12.5mg atweekly intervals to a tolerated dose that reduces chorea. Divide total daily doses over 37.5mg into three times daily.Maximum single dose 25mg. Maximum daily dose of 50mg. Monitor for e�cacy/ADRs.

Drug metabolism is decreased resulting in higher plasma concentrations and the potential for elevated risk of ADRs.[173]FOR H

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GenderM

DOB01/01/1980




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Legend:

ThioridazineTypical Antipsychotic



ConcernADR

Guidance

Thioridazine is contraindicated in patients with reduced CYP2D6 activity or with concomitant CYP2D6 inhibitors oragents that inhibit the metabolism of thioridazine due to the severe risk of fatal cardiac arrhythmias.

Drug metabolism is decreased resulting in higher plasma concentrations and elevated risk of ADRs including fatalcardiac arrhythmias. [34]

TramadolOpioid



ConcernE�cacy

Guidance

Consider an alternative drug not primarily metabolized by CYP2D6. Alternatively utilize standard dosing andmonitor for reduced e�cacy and for ADRs (28).

Tramadol is a prodrug that is converted to its active form by CYP2D6. Drug metabolism to the pharmacologicallyactive metabolite is decreased resulting in the potential for diminished therapeutic e�cacy (151,152). Higher dosesmay be necessary for adequate pain relief. [28, 151, 152, 287, 288]

TrimipramineTricyclic Antidepressant



ConcernADR

Guidance

Consider an alternative drug not primarily metabolized by CYP2D6 enzyme. Alternatively consider a 50% (39) to 70%(28) reduction of standard dosing recommendations and titrate to response while monitoring for e�cacy/ADRs (39).


VenlafaxineSNRI



ConcernADR

Guidance

Consider an alternative drug not primarily metabolized by the CYP2D6 enzyme. Alternatively, monitor for e�cacyand closely for tolerability as patient is at increased risk for ADRs due to higher venlafaxine levels.

Drug metabolism is decreased resulting in higher plasma concentrations of venlafaxine and potential elevated riskof ADRs. The clinical signi�cance of this is unknown as venlafaxine (VEN) is metabolized by CYP2D6 to an activecompound O-desmethylvenlafaxine (ODV). The impact of differing ratios of VEN to ODV is unknown. Thus gene-based dosing is not currently available. [28]

VortioxetineSerotonin Modulator



ConcernADR

Guidance

Consider a 5mg to 10mg once daily starting dose. The maximum dosage for CYP2D6 poor metabolizers is 10mgonce daily.

Drug metabolism is decreased resulting in higher plasma concentrations and elevated risk of ADRs. CYP2D6 PMshave approximately twice the plasma concentration of vortioxetine compared to EMs. [144, 145, 146]


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James Doe's detailed genetic test results are outlined below.

Alert Gene Tested Alleles Genotype Phenotype

CYP2D6*1, *2, *3, *4, *4J, *4K, *4M, *5, *6, *6C, *7, *8, *9, *10,*12, *14, *14B, *17, *29, *34, *35, *39, *41, *64, *65,*69, *70, XN

*4/*5 PM

CYP2C19 *1, *2, *3, *4, *4B, *5, *6, *8, *9, *10, *17 *1/*2 IM

CYP2C9 *1, *2, *3, *5, *6, *8, *11 *1/*1 EM

CYP3A4/5 EM

CYP3A4 *1, *1B, *2, *3, *12, *17, *22 *1/*1

CYP3A5 *1, *1D, *2, *3A, *3B, *3C, *6, *7, *9 *3A/*3A

VKORC1 -1639 G>A G/G Normal Sensitivity to Warfarin

SLCO1B1 *1, *5 *1/*1 EM

ATM rs11212617 A/C Increased Response

TPMT *1, *2, *3A, *3B, *3C *1/*1 EM

Factor V Leiden 1691G>A A/A Increased Risk

Prothrombin (Factor II) G20210A G/G Normal Risk


MTHFR A1298C A1298C A/C

MTHFR C677T C677T T/T

ApoE E2, E3, E4 E3/E3 Normal Risk

COMT VAL, MET VAL/MET Intermediate Activity

Results electronically approved and reported on Fri, Jul 19, 2019 by M. Beckwith

Phenotype De�nition (as used in this report)PM Poor Metabolizer Drug metabolism through the tested enzymatic pathway(s) is extremely reduced.IM Intermediate Metabolizer Drug metabolism through the tested enzymatic pathway(s) is slower than normal.EM/IM Reduced Metabolizer Drug metabolism through the tested enzymatic pathway(s) is slower than normal, but may not have clinical impact.EM Extensive Metabolizer Drug metabolism through the tested enzymatic pathway(s) is normal.RM Rapid Metabolizer Drug metabolism through the tested enzymatic pathway(s) is slightly faster than normal.UM Ultra Metabolizer Drug metabolism through the tested enzymatic pathway(s) is faster than normal.

Genetic Summary

< to c > R 2 V u Z X R p Y yB T d W1 tY X J 5 < /to c >

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Legend:

Current medications included in report Test panels included in report

Genetic Con�dence Level Not Genetically Evaluated Risk Factor Test Medication Panel

This Report Includes

< to c > V G h p c yB S Z X B vc n Q g S W5 jb H V k Z X M = < /to c >

Plavix (Clopidogrel Bisulfate)

raNITIdine HCl (Ranitidine HCl)

risperiDONE (Risperidone)

rOPINIRole HCl (Ropinirole Hydrochloride)

SEROquel (Quetiapine Fumarate)

Cardiovascular Disease

Hyperhomocysteinemia

Thrombosis

Comprehensive Genetic Drug Panel

Patient Medication List Ordered Panels and Tests

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DOB01/01/1980




Page20 of 20



The following icons and labels described below may or may not appear in this particular report.

Icon Label De�nition (as used in this report)PM Poor Metabolizer Drug metabolism through the tested enzymatic pathway(s) is extremely reduced.IM Intermediate Metabolizer Drug metabolism through the tested enzymatic pathway(s) is slower than normal.EM/IM Reduced Metabolizer Drug metabolism through the tested enzymatic pathway(s) is slower than normal, but may not have clinical impact.EM Extensive Metabolizer Drug metabolism through the tested enzymatic pathway(s) is normal.RM Rapid Metabolizer Drug metabolism through the tested enzymatic pathway(s) is slightly faster than normal.UM Ultra Metabolizer Drug metabolism through the tested enzymatic pathway(s) is faster than normal.

Not GeneticallyEvaluated Current literature does not identify any clinically signi�cant impact related to the tested genes.

Genetic Con�dence 0-4 0 - minimal or none; 1 - limited; 2 - moderate; 3 - signi�cant; 4 - strongDuplicate Therapy Potential of duplicate therapies.Drug Interaction Potential drug-drug interaction.Genetic Interaction Potential drug-gene metabolism issues.Lifestyle Interaction Potential drug-lifestyle interaction.Base Drug Risk Potential base risk associated with drug.ADR vs E�cacy High Risk High Bene�t; High Risk Low Bene�t; Low Risk High Bene�t; Low Risk Low Bene�tMedication List Indicates medication or report section applies to patient's current medication regimen, at time of report.Genetic Summary Patient's genotype and phenotype information.Risk Factor Test Tests indicate increased risk of certain conditions.Medication Panel Indicates section containing patient's ordered medication panel (Section Header), or speci�c medication panel ordered (This Report Includes).Guidance Information related to a speci�c medication for patient.Alternatives Suggested alternative medications.Alert Warnings or caution.

[xx] Literature referencesADR Adverse drug reaction

This genetic test and the reporting of clinical implications associated with speci�c genetic �ndings are intended to provide supplemental information to the healthcare provider in identifying themedication therapy best suited to each individual patient. This report does not constitute medical advice. The genetic test and reported clinical implications are intended to complement, notreplace, clinical observations and other information used by the healthcare provider in determining the best medication treatment plan for the patient. The patient’s healthcare provider isresponsible for providing medical advice and for making clinical decisions about medication management and treatment for the patient. As medical advice must be tailored to the speci�ccircumstances of each patient, the treating healthcare provider has ultimate responsibility, and GeneTrait® Laboratories disclaims any responsibility, for treatment decisions made with regardto the patient including any treatment decisions that take into account the patient’s genotype or other information provided in this report.Information such as drug interaction dynamics, the impact of lifestyle factors, and duplicate therapy are derived from the Wolters Kluwer Medi-Span drug databases. Wolters Kluwer is solelyresponsible for the accuracy and completeness of their data. This data will change over time as new medications enter the market and current drug information is updated. While we believethat this report is based on comprehensive current scienti�c information, it is possible that not all relevant published scienti�c information has been included in this report and GeneTrait®Laboratories disclaims responsibility for any omissions.

The individual alerts that are taken into consideration in the overall alert score include drug interactions for adverse drug reactions (0-5) and reduced e�cacy (0-5), inherent drug risk of thetarget medication (0-5), and genetic interactions for adverse drug reactions (0-5) and non-e�cacy (0-5). Individual alerts are rated on a scale of 0-5, where 0 represents no identi�ed ADRs ore�cacy issues and 5 equals some risk of serious injury or death. There is a maximum combined alert score of 25. The inherent drug risk of the target medication alone is established based ona number of factors including the frequency of monitoring necessary for the use of each medication. While use of required monitoring frequency is one indication of risk, it can sometimescause the inherent risk to be somewhat overstated or understated. Lifestyle factors and duplicate therapy risk are not considered in calculating the overall drug risk, but information currentlyavailable about each may be provided in the report.Potential alternative medications may be listed for medications provided that the total alert score for the alternative medication is less than the current medication. If the information provided toGeneTrait® Laboratories does not indicate the medical condition that the current medication has been prescribed to address, alternative medications are identi�ed in the same medicationclass for one of the most common uses of the medication, as denoted in the alternatives section. In some cases it will not be possible to identify a lower adverse drug reaction or non-e�cacymedication in the same medication class.

These interpretations, including genetic risk factors and the clinical implications associated with speci�c genetic �ndings, are based upon data available in the scienti�c literature andprescribing information for the relevant drugs. Scienti�cally supported information about genetics and medications is updated over time. This report provides information based on the dataavailable at the time of reporting, but may change in the future due to new discoveries and research. Apart from the medications and genetic factors considered in this laboratory report, the co-administration of other drugs that inhibit or induce the CYP enzymes, and other genetic and nongenetic factors, may alter the e�cacy or toxicity of medications mentioned in this report.Inclusion of any medication trade name in this report is not an indication of endorsement for a speci�c manufacturer or formulation of a medication. Commonly used trade names ofmedications may be provided in this report for reference. The provided names of medications may not represent all possible manufacturers or trade names of the denoted medication. Geneticreference citations and de�nitions of each risk scale are available upon request through the physician’s portal.

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M edTr ai t Repor t Sample Report.Detailed... · Columbia, MO 65201 Facility Phone (573) 442-9948 Facility Fax (573) 442-9870 Sample type Buccal Swab Collection date Fri, Jul 19,