Disclaimer Notice
Last updated: November 12, 2024.
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.
Test Disclaimer and Limitations
a. This test is meant only to understand your drug response based on your genetic makeup. The results presented in this report are offered as a piece of supplementary drug information. The results are as accurate as the information given on age, weight, height, ethnicity, CYP2C9 enzyme inducer status and Amiodarone status for 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. The report is based on genetic variants curated by PharmGKB and a publication, “Personalized Prescribing” that provides information on the impact of pharmacogenes on drug responses. The test does not rule out patient may have a different phenotype than reported due to the absence of a detectable pathogenic sequence variant or polymorphism. Inaccurate results may be due to interference from rare, unreported, unknown, unpublished gene variations. The information presented is intended for use by a physician, pharmacist or other healthcare professional (“Health Provider”) 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. Global Precision Diagnostics 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 one of Global Precision Diagnostics’ genetic counsellors, please liaise with our customer service hotline or request through our website.
b. 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 patient and may affect the reported detected variants’ accuracy. Accuracy and reliability for the assays are >99%. The test results do not include any new variants/genes associated with drugs with no scientific research and the result is limited to existing scientific research. You may still have a chance of having adverse drug reactions due to other non-genetic factors, such as; lifestyle factors, comorbidities, drug-drug interactions, age, weight, ethnicity, diet, concomitant therapy, and organ function. The results from the recipient’s blood sample after bone marrow transplants and / or liver transplants will not be accurate and 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.