Patient Disclaimer

IMPORTANT NOTICE: Do not make any changes to your medication without consulting your healthcare provider. Changing medications or dosages without consulting your physician could be harmful to your health. Your results may reveal that you process or respond to certain medications more or less effectively than the average person; however, genetics is only one of many factors influencing a medication's effectiveness. Please consult your healthcare provider before making any changes to your medication regimen. You must be at least 18 years of age to take a direct-to-consumer test.


PATIENTS CHOICE LABORATORIES DISCLAIMER: Patient Choice Laboratories developed the PGx genotype test on OpenArray. The performance characteristics of this test were determined by Patients Choice Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. These tests are used for clinical purposes. It should not be regarded as investigational or for research. The laboratory is regulated under the Clinical Laboratory improvement Act of 1988 as qualified to perform high complexity testing.


TRANSLATIONAL SOFTWARE DISCLAIMER: The PGx report is for use only by qualified healthcare professionals. The information presented on the report is provided as general educational health information. The content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Only a physician, pharmacist or other healthcare professional should advise a patient on the use of the medications prescribed. The pharmacogenetic assay involves use of reporting software and genotype-phenotype associations performed by Translational Software ( Phenotype prediction and interpretation is based on a subset of selected variants interrogated. Assignment of the reference allele/haplotype (e.g., *1 allele) indicates that none of the interrogated variants were detected. The pharmacogenetic assays cannot differentiate between maternal and paternal chromosomes and detected variants can be associated with more than one diplotype. Where lack of chromosomal phasing leads to ambiguity in diplotyping, Translational Software may suggest the most likely diplotype to Laboratory Directors based on published allele frequencies and/or ethnicity data. The software has not been evaluated by the Food and Drug Administration. The software, and the report generated by the software, is not intended to diagnose, treat, cure, or prevent any disease. A qualified designee within the lab uses Translational Software to generate and subsequently review the report. The pharmacogenetic report is one of multiple pieces of information that clinicians should consider in guiding their therapeutic choice for each patient. It remains the responsibility of the health-care provider to determine the best course of treatment for a patient. Adherence to dose guidelines does not necessarily ensure a successful medical outcome.


LIMITATIONS: Patients Choice Laboratories PGx Reports will test only the genes and SNPs listed within each report. The test will not detect all known alleles that result in altered or inactive tested genes. The PGx reports do not account for all individual variations in the individual tested. Absence of a detectable gene mutation does not rule out the possibility that the patient has different phenotypes due to the presence of an undetected polymorphism or due to other factors such as drug-drug interactions, comorbidities and lifestyle habits.

METHODOLOGY: OpenArray based assays detect listed alleles by RT-PCR, including all common and most rare variants with known clinical significance at analytical sensitivity and specificity >99%.