Pharmacogenomics Accuracy

Global Precision Wellness

DNA Test Disclaimer - Pharmacogenomics

Updated : 2 September 2025

This policy address key areas such as the test’s limitations, accuracy, clinical relevance, and any potential risks or uncertainties associated with interpreting genetic data.

A

This test is meant only for understanding your drug response based on your genetic makeup. The results presented on this report is offered as a supplementary drug information to assist physician/medical doctor in providing personalized medical treatment and recommendations for you.

The results are as accurate as the information given on age, weight and ethnicity; additional of height, CYP2C9 enzyme inducer status and Amiodarone status for International Warfarin Pharmacogenetics Consortium (IWPC) guided Warfarin Dosing.

The IWPC guided Warfarin Dosing Algorithm takes into account the following genotype: VKORC1(rs9923231) G/A, VKORC1(rs9923231) A/A, VKORC1(rs9923231) genotype unknown, CYP2C9 *1/*2, CYP2C9 *1/*3, CYP2C9 *2/*2, CYP2C9 *2/*3, CYP2C9 *3/*3 and CYP2C9 genotype unknown.

B

The report is based on genetic variants curated by PharmGKB and publication that provides information on the impact of pharmacogenes on drug responses. 

The list of Tier 1 genetic variants that are detectable in the assay is outlined below, but is not limited to:

Gene Names Variant (rs ID)

ABCG2

rs2231142G, rs2231142T

CYP2C19

*1, *2, *3, *4.001, *4.002, *5, *6, *7, *8, *9, *10, *12, *13, *14, *15, *16, *17, *18, *19, *22, *23, *24, *25, *26, *28, *34, *35

CYP2C9

*1, *2, *3, *4, *5, *6, rs9332094C, *9, *10, *11, *12, *13, *15, *16, *17, *18, *19, *20, *21, *23, *24, *25, *26, *29, *30, *31, *32, *34, *36, *2+36, *38, *39, *40, *42, *43, *44, *45, *46, *47, *48, *49, *50, *51, *52, *53, *54, *55, *56, *57, *58

CYP2D6

*1, *2, *4, *4.009, *4.010, *4.021, *6, *7, *8, *9, *10, *11, *14, *15, *17, *18, *22, *23, *25, *28, *29, *31, *33, *34, *35, *35+R365H, *40, *42, *45, *49, *51, *53, *54, *55, *56.001, *56.002, *62, *70, *71, *73, *75, *84, *86, *88, *95, *100, *103, *107, *109, *114, *139, *142, *154, *164, *171, *5

CYP3A4

*1, *2, *3, *4, *5, *6, *7, *8, *9, *10, *11, *12, *13, *14, *15, *16, *17, *18, *19, *20, *22, *23, *37, *38

CYP3A5

*1, *3, *6, *7, *8

CYP4F2

*1, *2, *3, *4, *6

DPYD

c.=, c.61C>T, c.295_298delTCAT, c.557A>G, c.703C>T, c.1129-5923C>G, HapB3, c.1156G>T, c.1679T>G, c.1898delC, c.1905+1G>A, c.2846A>T, c.2983G>T

G6PD

B, A, Asahi, A-(202A_376G), Ube_Konan, Viangchan, Mira_d_Aire, Canton, 202A_376G_1264G, Sinnai, Lages, Gaohe, Honiara, Sunderland, Rignano, Orissa, Aures, Kambos, Kozukata, Kamogawa

Palestrina, Metaponto, Costanzo, Amsterdam, Amazonia, Pro62Arg, Musashino, Songklanagarind, Hechi, Namouru, Murcia_Oristano, Swansea, Val77Leu, Lagosanto, Guangzhou, Urayasu, Vancouver, Hammersmith, Sao_Borja, Bao_Loc

Crispim, Acrokorinthos, Santa_Maria, Ananindeua, A-(680T_376G), A-(968C_376G), Mt_Sinai, Vanua_Lava, Quing_Yan, Valladolid, Belem, Liuzhou, Ilesha, Shenzhen, Mahidol, Plymouth, Taipei, Toledo, Naone, Volendam

Nankang, Miaoli, Shinshu, Chikugo, Malaga, Tsukui, Mediterranean, Pedoplis-Ckaro, Coimbra_Shunde, Nilgiri, Santiago, Arg198Leu, Sibari, Minnesota, Cincinnati, Harilaou, Radlowo, Mexico_City, North_Dallas, Asahikawa

Nanning, Durham, Stonybrook, Wayne, Aveiro, Roubaix, Cleveland_Corum, Lille, Bangkok, Sugao, La_Jolla, Wexham, Thr279Pro, Haikou, Chinese-1, Mizushima, Piotrkow, Osaka, Montalbano, West_Virginia

Seoul, Omiya, Ludhiana, Kalyan-Kerala, Nara, Manhattan, Rehevot, Farroupilha, Insuli, Villeurbanne, Chatham, Fushan, Torun, Chinese-5, Partenope, Ierapetra, Iwatsuki, Serres, Loma_Linda, Tenri

Tondela, MontpellierCalvo_Mackenna, Riley, Olomouc, Tomah, Lynwood, Madrid, Iowa, Guadalajara, Beverly_Hills, Hartford, Praha, Krakow, Wisconsin, Nashville, Alhambra, Bari, Puerto_Limon, Anadia, Covao_do_Lobo

Clinic, Abeno, Utrecht, Suwalki, Riverside, Japan, Munich, Tokyo, Georgia, Surabaya, Sumare, Pawnee, Telti_Kobe, Santiago_de_Cuba, S_Antioco, Cassano, Hermoupolis, Harima, Union, Andalus, Figuera_da_Foz

Amiens, Cosenza, Bangkok_Noi, Nice, Flores, Arg463Gly, Kamiube, Kaiping, Neapolis, Split, Fukaya, Campinas, Buenos_Aires, Arakawa, Brighton, Null

NUDT15

*1, *3

SLCO1B1

*1, *37, *2, *3, *4, *5, *6, *7, *8, *9, *11, *13, *14, *15, *16, *23, *24, *25, *26, *27, *28, *29, *30, 31, *32, *33, *41, *47

TPMT

*1, *2, *3B, *3C, *3A, *3D, *4, *5, *6, *7, *8, *9, *10, *11, *12, *13, *14, *15, *16, *17, *18, *19, *20, *21, *23, *24, 25, *26, *27, *28, *29, *30, *31, *33, *34, *35, *36, *37

UGT1A1

*1, *6, *27, *28, *36, *80, *80+*28

VKORC1

c.=, c.-1639G>A, c.106G>T, c.196G>A, c.383T>G

C

The test does not rule out that the patient may have a different phenotype than reported due to absence of a detectable gene variant.

Inaccurate results may be due to interference from rare, unreported, unknown, unpublished gene variations.  

D

The information presented is intended for use by a physician, pharmacist or other healthcare professional to be considered as one of the guides to advise a patient on the use of prescription drugs and therapeutic choice.

The test results are not meant to be regarded as the sole source of recommendation for the next course of treatment. The ordering physician/healthcare provider is responsible for the diagnosis and management of disease and best course of treatment for a patient based on the data provided. Adherence to guidelines does not necessarily assure a successful medical outcome.

Please consult your healthcare provider for all medical advice. Results are dependent on adequate specimen collection and processing.

The Service Provider will not be held liable for any direct, indirect, special, consequential, exemplary, punitive, or any other damages arising from the use of the information and/or service within this report.

If you have any questions about this report or wish to speak with Global Precision Diagnostics, please contact them through their website.

Limitations

A

This assay only detects specific loci genetic variants available in the array. Mosaicism cannot be detected with this assay. Variants not included in the assay may still be present in the patient and could impact the accuracy of the reported detected variants. 

B

Accuracy and reliability for the assays are >99%. The test results do not include all new variants/genes associated with drugs with no scientific research and the result is limited to existing scientific research. Global Precision Wellness reserves the right to update the list of reportable variants periodically as clinical knowledge and guidelines advance.  

C

The effectiveness of the medication and the risk of adverse drug reactions can also be influenced by non-genetic factors, such as lifestyle factors, comorbidities, age, weight, ethnicity, and diet. Drug-related factors including narrow therapeutic index, decreased drug clearance due to impaired renal or hepatic functions, drug-drug interactions resulting from concomitant therapy, food-drug interactions, drug allergies or intolerance, may also impact medication effectiveness and the likelihood of adverse reactions. 

The results from the recipient blood sample after bone marrow transplants and/or liver transplants will not be applicable due to interference with this test. Genotyping error chances cannot be excluded completely.

Future research may reveal changes in the interpretation of previously obtained genetic testing results as this test result is based upon current information, development and testing techniques. 

Global Precision Diagnostics will notify you of any amendments or modifications in the report or results through the PreciseEHR mobile application.  

Methodology

A

Genomic DNA is extracted from dry buccal swabs using magnetic particle processing or spin column processing. DNA from patient samples is amplified and positive controls are used with each run. Patient samples and positive controls are genotyped using the Genome Wide Technology. 

The raw data are analysed using AxiomTM Analysis Suite software v4.0.3.3 for presence or absence of single nucleotide base changes, insertions, deletions, and copy number variants to confirm CYP2D6 duplication and deletions.

B

Genetic testing was performed in the Molecular Diagnosis Laboratory of Global Precision Diagnostics Sdn. Bhd. at No. 1, Jalan 215, Off, Jalan Templer, Section 51, 46050 Petaling Jaya, Selangor. 

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Pharmacogenomics Accuracy - DNA Test Disclaimer - Pharmacogenomics