Disclaimer Notice
Last updated: September 9, 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.
PRECISE Pharmacogenomics Test Disclaimer
i. This test is meant only for understanding your drug response based on your genetic makeup. The results presented in this report are offered as supplementary drug information to assist physicians/medical doctors in providing personalised medical treatment and recommendations for you. The results are as accurate as the information given on age, weight and ethnicity; addition of height, CYP2C9 enzyme inducer status and Amiodarone status for IWPC guided Warfarin Dosing. The International Warfarin Pharmacogenetics Consortium (IWPC) guided Warfarin Dosing Algorithm takes into account the following genotypes: 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.
ii. The report is based on genetic variants curated by PharmGKB, a 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:
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
iii. 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.
iv. 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 the 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 us through our website.
A. Limitations
i. 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.
ii. 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. GPD reserves the right to update the list of reportable variants periodically as clinical knowledge and guidelines advance.
iii. 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. GPD will notify you of any amendments or modifications in the report or results through the PreciseEHR mobile application.
B. Methodology
i. 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.
ii. Genetic testing was performed in the Molecular Diagnostics Laboratory of Global Precision Diagnostics Sdn. Bhd. at No. 1, Jalan 215, Off, Jalan Templer, Section 51, 46050 Petaling Jaya, Selangor.
PRECISE Nutrigenomics Test Disclaimer
i. This test is intended solely to provide insights into your body’s ability to metabolize or respond to certain nutrients based on your genetic makeup. It does not evaluate medical conditions, genetic disorders, or disease risk.
ii. The list of genetic variants that are detectable in the assay is outlined below, but is not limited to:
MC4R g.60183864T>C, ZBED3-AS1 g.77129124G>A, ADRB3 g.37966280A>G, APOA2 g.161223893G>A, PPARG2 g.12351626C>G, TMEM258 g.61792609G>A, TMEM258 g.61792609G>A, FADS1 g.61803876C>G, ELOVL2 g.10982740T>C, FADS1 g.61803876C>G, NPC1L1 g.44525136T>C, FTO g.53782363C>A, MC4R g.60183864T>C, CD36 g.80672184G>A, BCO1 g.81230992T>G, BCO1 g.81268089A>T, BCO1 g.81280891C>T, NBPF3 g.21459575C>T, MTHFR g.11794419T>G, MTHFR g.11796321G>A, CLYBL g.99866380C>T, MS4A3 g.60069719C>T, PRELID2 g.145659268T>C, SLC23A1 g.139379813C>T, CYP2R1 g.14893332A>G, NADSYN1 g.71456403G>T, GC g.71752617A>C, SCARB1 g.124822507G>A, ZNF259 g.116778201G>C , CYP4F2 g.15879621C>T, VKORC1 g.31096368C>T, AGT g.230710048A>G, RPS20P12 g.234394166C>T, IRAK1BP1 g.78846449T>C, HNRNPA1P48 g.51576036G>A, GC g.71752617A>C, NBPF3 g.21496799C>T, CSTA g.122329797A>G, IP6K3 g.33738702C>T, MUC1 g.155192276C>T, DCDC1 g.30738788T>C, TRPM6 g.74884880T>C, SLC30A8 g.117172544C>T, SLC30A8 g.117173494A>G, TF g.133765185G>A, HFE g.26090951C>G, DMGDH g.79020653C>T, NQO1 g.69711242G>A, SOD2 g.159692840A>G, CYP1A2 g.74749576C>A, HLA-DQ2 g.32445540G>T, TCF7L2 g.113049143G>T, MCM6 g.135851076G>A, ALDH2 g.111803962G>A, ABCG2 g.88131171G>T, CYP1A2 g.74749576C>A, GSTT1 Deletion, GSTM1 Deletion
iii. The results presented in this report are offered as a supplementary tool to aid in understanding an individual’s nutrient metabolism, tolerance, and response, and are intended for use by healthcare professionals such as dietitians and nutritionists. These results may support the application of medical nutrition therapy for personalized recommendations and the development of effective health management plans aimed at preventing or managing diet-related chronic diseases and conditions.
iv. This test is not intended to serve as a sole source of information or as a substitute for professional medical advice, diagnosis, or treatment. The ordering physician or healthcare provider is responsible for the diagnosis and management of disease and for determining the most appropriate course of treatment for each patient, based on the data provided. Adherence to dietary recommendations provided in this report does not guarantee a successful medical outcome. Please consult your healthcare provider for all medical advice. Results are dependent on adequate specimen collection and processing.
v. The Service Provider will not be held liable for any direct, indirect, special, consequential, exemplary, punitive, or other damages arising from the use or interpretation of the information and/or services contained within this report. If you have any questions about this report or wish to speak with one of Global Precision Diagnostics’ (GPD) representatives, please contact us through our website.
A. Limitations
i. This assay only detects specific loci genetic variants available in the array. Mosaicism cannot be detected with this assay. Variants that are not included in the assay may be present in the individual and may affect the reported detected variants accuracy. Accuracy and reliability for the assays are >99%. The test results do not include all new variants/genes associated with nutrient metabolism for which no scientific evidence currently exists. Nutrigenomic insights are limited to existing scientific research, which continues to evolve. GPD reserves the right to update the list of reportable variants periodically as clinical knowledge and guidelines advance.
ii. Nutrigenomics test identifies the genetic variations that may influence how individuals metabolize and respond to certain nutrients. However, food tolerance, nutrient metabolism, body composition, eating habits, dietary requirements and overall nutrient response are also influenced by non-genetic factors such as lifestyle, environment, comorbidities, food-drug interactions, concurrent therapies. This test does not measure actual nutrient levels in the body; additional laboratory tests (e.g., blood or urine analysis) may be required to assess the current nutritional status. The test cannot predict food allergies and/or other immune-mediated reactions.
iii. The results derived from 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. GPD will notify you of any amendments or modifications in the report or results through the PreciseEHR mobile application.
B. Methodology
i. Genomic DNA is extracted from dry buccal swabs or whole blood using magnetic particle processing or spin column processing. DNA from individual samples is amplified, and positive controls are used with each run. Both individual samples and positive controls are screened using the Genome Wide Technology. Data are analysed for the presence or absence of single nucleotide base changes, insertions, deletions, and copy number variants to confirm gene duplication and deletions.
ii. Genetic testing was performed in the Molecular Diagnosis Laboratory of Global Precision Diagnosis Shd. Bdn. at No. 1, Jalan 215, Off, Jalan Templer, Section 51, 46050 Petaling Jaya, Selangor.
