omecare | at home dna test kits for health & wellness · 2021. 3. 1. · paliperidone patient...

OmePsychiatricMedsPersonal Genetic Repor

Protected Health Information

PERSONAL DETAILS

NAME Sample Patient

DOB Jan 1, 1980

SEX M

ETHNICITY Caucasian

ORDERING HEALTHCARE

PROFESSIONAL

Michael Nova M.D.

MENTAL HEALTH DNA INSIGHT®


Test Results Reviewed & Approved by:

Laboratory Director,

Michael Nova M.D.

LABORATORY INFO

ACTIVATION

CODEYAHAN-VKCJI

SPECIMEN TYPE BUCCAL SWAB

COLLECTED

DATEMAR 20, 2020

RECEIVED DATE MAR 25, 2020

REPORT DATE APR 12, 2020

Drug Class Drug Preferential Use Use As DirectedMay Have Significant

Limitations

May Cause Serious

Adverse Events

Citalopram

Escitalopram

Fluoxetine

Fluvoxamine

Paroxetine

Sertraline

SSRIs

Vilazodone

Amitriptyline

Clomipramine

Desipramine

Doxepin

Imipramine

Nortriptyline

Protriptyline

TCAs

Trimipramine

Bupropion

Buspirone

Duloxetine

Levomilnacipran

Mirtazapine

Nefazodone

Trazodone

Venlafaxine

Other Antidepressants

Vortioxetine

See Disclaimer(s) on page 8 of this Report · Copyright © 2020 OmeCare · All Rights Reserved. Patents Pending.

Laboratory Director: Jess Savala Jr. CLIA Number: 05D1092505 · 6777 Nancy Ridge Drive, San Diego, CA 92121 · https://www.omecare.com PAGE 1 of 9

Drug Class Drug Preferential Use Use As DirectedMay Have Significant

Limitations

May Cause Serious

Adverse Events

Aripiprazole

Asenapine

Clozapine

Iloperidone

Lurasidone

Olanzapine

Paliperidone

Quetiapine

Risperidone

Atypical Antipsychotics

Ziprasidone

Haloperidol

Perphenazine

Pimozide

Thioridazine

Typical Antipsychotics

Zuclopenthixol

Divalproex

Lamotrigine

Oxcarbazepine

Phenytoin

Mood Stabilizers

Valproic acid

Norepinephrine

Reuptake InhibitorAtomoxetine

Alprazolam

ClobazamBenzodiazepines

Diazepam

Dextromethorphan

and Quinidine

Galantamine

Modafinil

Others

Tetrabenazine



NAME SAMPLE PATIENT

SEX M

ACTIVATION

CODEYAHAN-VKCJI

REPORT DATE APR 12, 2020



May Have Significant Limitations

Drug Class Drug Comments

Clozapine In smokers, this CYP1A2 genotype is associated with decreased plasma concentrations

of clozapine, which may lead to decreased efficacy at standard doses. This

recommendation does not apply to patients of Asian ancestry.


Olanzapine Patient's genotype is associated with decreased plasma concentrations of olanzapine,

which may lead to decreased efficacy. This recommendation does not apply to patients of

Asian ancestry.

Benzodiazepines Alprazolam This patient is likely to have increased plasma concentrations of alprazolam and reduced

oral clearance of alprazolam at standard doses. Due to the limited clinical evidence, there

are no specific recommendations on dose adjustment of alprazolam.

Preferential Use


Citalopram Patient's HTR2A genotype is associated with an increased likelihood of response to

citalopram treatment in Caucasians.

Patient's SLC6A4 genotype is associated with decreased risk of adverse effects when

citalopram is used to treat major depressive disorder.

Fluoxetine Patient's SLC6A4 genotype is associated with decreased risk of adverse effects when

fluoxetine is used to treat major depressive disorder.

Fluvoxamine Patient's SLC6A4 genotype is associated with decreased risk of adverse effects when

fluvoxamine is used to treat major depressive disorder.

Patient's HTR2A genotype is associated with decreased risk of adverse effects, such as

headache, nausea, drowsiness, agitation, sexual dysfunction or weight gain, when

fluvoxamine is administered.

SSRIs

Paroxetine Patient's SLC6A4 genotype is associated with decreased risk of adverse effects when

paroxetine is used to treat major depressive disorder.

Other Antidepressants Venlafaxine Patient's SLC6A4 genotype is associated with an increased response to venlafaxine.

Aripiprazole Patient has decreased risk of weight gain if treated with atypical antipsychotics, including

aripiprazole.

Asenapine Patient has decreased risk of weight gain if treated with atypical antipsychotics, including

asenapine.

Iloperidone Patient has decreased risk of weight gain if treated with atypical antipsychotics, including

iloperidone.

Lurasidone Patient has decreased risk of weight gain if treated with atypical antipsychotics, including

lurasidone.

Paliperidone Patient has decreased risk of weight gain if treated with atypical antipsychotics, including

paliperidone.

Quetiapine Patient has decreased risk of weight gain if treated with atypical antipsychotics, including

quetiapine.

Risperidone Patient has decreased risk of weight gain if treated with atypical antipsychotics, including

risperidone.


Ziprasidone Patient has decreased risk of weight gain if treated with atypical antipsychotics, including

ziprasidone.



NAME SAMPLE PATIENT

SEX M

ACTIVATION

CODEYAHAN-VKCJI

REPORT DATE



APR 12, 2020

Use As Directed


Escitalopram

Sertraline

The most recent label for this drug should be consulted for up-to-date dosing guidelines

and limitations.SSRIs

Vilazodone The most recent label for this drug should be consulted for up-to-date dosing guidelines

and limitations. The recommended dose of vilazodone should reduce to 20mg if co-

administered with strong or moderate CYP3A4 inhibitors.

Amitriptyline

Clomipramine

Desipramine

Doxepin

Imipramine

Nortriptyline

Protriptyline

TCAs

Trimipramine


and limitations.

Bupropion The most recent label for this drug should be consulted for up-to-date dosing guidelines

and limitations.

Buspirone The most recent label for this drug should be consulted for up-to-date dosing guidelines

and limitations. Concurrent use of buspirone and CYP3A4 inhibitors may lead to

increased plasma concentrations of buspirone with potential adverse effects, and

subsequent dose adjustment may be necessary.

Duloxetine The most recent label for this drug should be consulted for up-to-date dosing guidelines

and limitations.

Levomilnacipran The most recent label for this drug should be consulted for up-to-date dosing guidelines

and limitations. The recommended dose of levomilnacipran should not exceed 80mg once

daily if co-administered with strong CYP3A4 inhibitors, including ketoconazole,

clarithromycin and ritonavir.

Mirtazapine

Nefazodone


and limitations.

Trazodone The most recent label for this drug should be consulted for up-to-date dosing guidelines

and limitations. Concurrent use of trazodone and CYP3A4 inhibitors may lead to

substantial increase in plasma concentrations of trazodone with potential adverse effects

including nausea, hypotension and syncope.

Other Antidepressants

Vortioxetine The most recent label for this drug should be consulted for up-to-date dosing guidelines

and limitations.

Haloperidol

Perphenazine

Pimozide

Thioridazine

Typical Antipsychotics

Zuclopenthixol


and limitations.



NAME SAMPLE PATIENT

SEX M

ACTIVATION

CODEYAHAN-VKCJI

REPORT DATE



APR 12, 2020

Use As Directed (Continued)


Divalproex

Lamotrigine

Oxcarbazepine


and limitations.

Phenytoin Patient's genotype is consistent with the absence of the HLA-B*1502 allele. Therefore,

patient has a low risk of developing serious skin reactions, such as Stevens-Johnson

syndrome or toxic epidermal Necrolysis (SJS/TEN), when treated with phenytoin. This

genetic test is most applicable to patients of Han Chinese descent. If clinically indicated,

patients of other Asian ethnicities may be advised to undergo HLA sequencing to assess

their risk of phenytoin hypersensitivity. There are insufficient data to associate this allele

with phenytoin hypersensitivity in other ethnicities.

Mood Stabilizers

Valproic acid The most recent label for this drug should be consulted for up-to-date dosing guidelines

and limitations.

Norepinephrine

Reuptake Inhibitor

Atomoxetine The most recent label for this drug should be consulted for up-to-date dosing guidelines

and limitations.

ClobazamBenzodiazepines

Diazepam


and limitations.

Dextromethorphan

and Quinidine

Galantamine

Modafinil

Others

Tetrabenazine


and limitations.



NAME SAMPLE PATIENT

SEX M

ACTIVATION

CODEYAHAN-VKCJI

REPORT DATE



APR 12, 2020

GENOTYPE/HAPLOTYPE DETAIL

PHARMACOGENETICS

This section lists the genetic markers that were tested. Results are organized by gene. Each gene has up to three sections, which may include

a "Metabolizer Status" section, a "Genetic Result" section and an associated table with three columns. "Metabolizer Status" indicates the

patient's predicted metabolizer status. "Genetic Result" indicates the haplotype, genotype or presence of a mutation. A genetic result that

contains “ND” indicates that a haplotype could not be determined. “Unable To Report” indicates that no result can be provided.

In the tables, results are organized by gene in three columns:

1. “Gene/Locus” refers to the gene or intergenic region where the marker is located.

2. “Marker” refers to the unique identifier of the tested marker.

3. “Genotype” refers to the combination of nucleotides at a particular marker. The letter(s) on each side of the slash refer(s) to the two

copies of the patient’s DNA. "Del" indicates a deletion of the nucleotide(s) in the patient's DNA. A genotype of “- -“ indicates that a

result could not be obtained.

CYP1A2GENE/LOCUS MARKER GENOTYPE

CYP1A2 rs762551 A/A

CYP2B6

Metabolizer Status: Extensive Metabolizer

Genetic Result: CYP2B6 *1/*5

GENE/LOCUS MARKER GENOTYPE

CYP2B6 rs2279343 A/A

CYP2B6 rs3211371 C/T

CYP2B6 rs3745274 G/G

CYP2B6 rs8192709 C/C

CYP2B6 rs28399499 A/A

CYP2C19


Genetic Result: CYP2C19 *1/*1


CYP2C19 rs4244285 G/G

CYP2C19 rs4986893 G/G

CYP2C19 rs12248560 C/C

CYP2C19 rs28399504 A/A

CYP2C19 rs41291556 T/T

CYP2C19 rs56337013 C/C

CYP2C19 rs72552267 G/G

CYP2C19 rs72558186 T/T

CYP2C9




CYP2C9 rs1057910 A/A

CYP2C9




CYP2C9 rs1799853 C/C

CYP2C9 rs9332131 A/A

CYP2D6


Genetic Result: CYP2D6 *1/*6


CYP2D6 rs16947 C/C

CYP2D6 rs769258 G/G

CYP2D6 rs1065852 C/C


CYP2D6 rs3892097 G/G

CYP2D6 rs5030655 T/del

CYP2D6 rs5030656 AAG/AAG

CYP2D6 rs5030862 G/G



CYP2D6 rs5030867 A/A

CYP2D6 rs28371706 C/C

CYP2D6 rs28371725 G/G

CYP2D6 rs35742686 A/A

CYP2D6 rs59421388 C/C

CYP2D6 rs72549357 T/T


CYP3A4 rs4646438 A/A

CYP3A4 rs4987161 --


CYP3A4 rs12721629 --

CYP3A4 rs35599367 C/T

CYP3A4 rs55901263 C/C

CYP3A4 rs55951658 A/A

CYP3A4 rs67666821 A/A

CYP3A4 rs67784355 --

CYP3A4 rs138105638 C/C

CYP3A5

Metabolizer Status: Non-Expressor

Genetic Result: CYP3A5 *3/*3


CYP3A5 rs776746 C/C

DRD2GENE/LOCUS MARKER GENOTYPE

DRD2 rs1799732 C/C

HLA-A

Genetic Result: HLA-A x/x


HLA Region rs1061235 A/A

HLA-B

Genetic Result: HLA-B x/x


HLA Region rs2844682 C/C

HLA Region rs3909184 G/G



NAME SAMPLE PATIENT

SEX M

ACTIVATION

CODEYAHAN-VKCJI

REPORT DATE



APR 12, 2020

HTR2AGENE/LOCUS MARKER GENOTYPE

HTR2A rs7997012 A/A

HTR2AGENE/LOCUS MARKER GENOTYPE

HTR2A rs6311 A/A

HTR2CGENE/LOCUS MARKER GENOTYPE

HTR2C rs1414334 G/G

HTR2C rs3813929 G/A

POLGGENE/LOCUS MARKER GENOTYPE

POLG rs113994095 G/G



SLC6A4

Genetic Result: SLC6A4 L(A)/L(A)


SLC6A4 5-HTTLPR L/L

SLC6A4 rs25531 A/A

UGT1A4GENE/LOCUS MARKER GENOTYPE

UGT1A4 rs2011425 A/A



NAME SAMPLE PATIENT

SEX M

ACTIVATION

CODEYAHAN-VKCJI

REPORT DATE



APR 12, 2020

TEST METHODOLOGY

Genotyping by PCR-based enrichment and next-generation sequencing or by array-based evaluation of multiple molecular probes.

DISCLAIMER

This test was developed and its performance characteristics determined by OmeCare. It has not been cleared or approved by the FDA. The

laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be

regarded as investigational or for research.

If you have any questions about this report or wish to speak with one of OmeCares' genetic counselors, please call (877) 505.7374.

RISKS AND LIMITATIONS

Risk of Laboratory Technical Problems or Laboratory Error

The certified testing laboratory has standard and effective procedures in place to protect against technical and operational problems. However,

such problems may still occur. The testing laboratory receives samples collected by patients and physicians. Problems in shipping to the

laboratory or sample handling can occur, including but not limited to damage to the specimen or related paperwork, mislabeling, and loss or

delay of receipt of the specimen. Laboratory problems can occur that might lead to inability to obtain results. Examples include, but are not

limited to, sample mislabeling, DNA contamination, un-interpretable results, and human and/or testing system errors. In such cases, the testing

laboratory may need to request a new sample. However, upon re-testing, results may still not be obtainable.

As with all medical laboratory testing, there is a small chance that the laboratory could report inaccurate information. For example, the laboratory

could report that a given genotype is present when in fact it is not. Any kind of laboratory error may lead to incorrect decisions regarding medical

treatment and/or diet and fitness recommendations. If a laboratory error has occurred or is suspected, a health care professional may wish to

pursue further evaluation and/or other testing. Further testing may be pursued to verify any results for any reason.

Limitations

The purpose of this test is to provide information about how a tested individual’s genes may affect carrier status for some inherited diseases,

responses to some drugs, risk for specific common health conditions, and/or selected diet, nutrition and/or exercise responses, as well as to

learn more about the tested individual’s ancient ancestry, depending upon the specific genetic testing that is ordered by the health care

professional. Tested individuals should not make any changes to any medical care (including but not limited to changes to dosage or frequency

of medications, diet and exercise regimens, or pregnancy planning) based on genetic testing results without consulting a health care

professional.

The science behind the significance or interpretation of certain testing results continues to evolve. Although great strides have been made to

advance the potential usefulness of genetic testing, there is still much to be discovered. Genetic testing is based upon information,

developments and testing techniques that are known today. Future research may reveal changes in the interpretation of previously obtained

genetic testing results. For example, any genetic test is limited by the variants being tested. The interpretation of the significance of some

variants may change as more research is done about them. Some variants that are associated with disease, drug response, or diet, nutrition and

exercise response may not be tested; possibly these variants have not yet been identified in genetic studies.

Many of the conditions and drug responses that are tested are dependent on genetic factors as well as nongenetic factors such as age, personal

health and family health history, diet, and ethnicity. As such, an individual may not exhibit the specific drug response, disease, or diet, nutrition

and exercise response consistent with the genetic test results.

Another limitation for some conditions, particularly in the areas of diet and exercise, is that genetic associations have been studied and observed

in Caucasian populations only, and in some cases only in one gender. In this case, the interpretations and recommendations are made in the

context of Caucasian studies, but the results may or may not be relevant to tested individuals who are of non-Caucasian or mixed ethnicities or

the non-studied gender. If patient ethnicity is not disclosed in the test requisition form the ethnicity field in the report will read as "Ethnicity: Not

Reported". Such reports will be defaulted to phenotype list displayed for Caucasian ethnicity.

Based on test results and other medical knowledge of the tested individual, health care professionals might consider additional independent

testing, or consult another health care professional or genetic counselor.



NAME SAMPLE PATIENT

SEX M

ACTIVATION

CODEYAHAN-VKCJI

REPORT DATE



APR 12, 2020

RESULT STATUS DEFINITIONS

Amended Test results and/or patient information that have been revised in a way that does

not impact the clinical significance of the result(s) and/or patient diagnosis,

treatment or management.

Corrected Test results and/or patient information that have been revised in a way that may

impact the clinical significance of the result(s) and/or patient diagnosis, treatment

or management.

Final Test results that are available at the time of report issue or have been revised

from pending status to final status.

Pending Test results that are not available at the time of report issue. All pending results

will be specified in the report.



NAME SAMPLE PATIENT

SEX M

ACTIVATION

CODEYAHAN-VKCJI

REPORT DATE



APR 12, 2020

omecare | at home dna test kits for health & wellness · 2021. 3. 1. · paliperidone patient...

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