Informed Consent

PHARMACOGENOMIC TESTING
INFORMED CONSENT

By purchasing a test kit from Pro-GeneX.com and/or completing the registration process using the RxGeneAlert™ system, the user agrees to the informed consent terms listed below.

What is Pharmacogenomic testing? Pharmacogenomic testing is one tool that you and your provider can use to aid in determining the best medication for you. It looks at certain genetic changes that can impact how you metabolize, absorb, or respond to a particular medication. It is important to remember that other factors, such as age, other medications you are taking, and medical conditions can also impact how a medication may affect you.

What are the possible results of this test? The results will tell your doctor about genetic changes that may affect how you process certain medications. The results of this testing can reveal some inherited or genetic changes that might make a person unresponsive or hypersensitive to a particular medication. Other genetic or inherited changes might help explain why a person may experience harmful effects from some medications.

People who are found to be “extensive metabolizers” will probably process the medication normally. Those who are “intermediate metabolizers” or “poor metabolizers” may experience reduced effectiveness of some medications or might experience unwanted adverse effects from some medications. On the other hand, patients who are “ultra-rapid metabolizers” may process a medication more quickly. This can also affect how well the medication works at the recommended dose.

What is the test used for? This MyBestMed™ test will help doctors decide whether a medication will work for you and how likely it is to cause unwanted adverse effects. Your doctor may use the results to adjust your dose or consider other treatments.

IT IS VERY IMPORTANT to know that the report may indicate suggestions to change the dosage of your medication(s), or to change the medication itself. Since your physician knows your health and medication history best, it is important that you do NOT change any medication or treatment until you discuss your results with your healthcare provider. This information is meant as a guide, and there are other factors that influence how well medications will work.

What are the limitations of the test? For some medications, the results will give clear guidance for deciding the best dose. However, for other medications, there are no established dosing guidelines based on the results. Therefore, your doctor may need to try a few dose or treatment adjustments to see what works best for you. In addition, this test does not identify all genetic changes that could affect treatment decisions.

Therefore, some people with normal test results may still process medications too quickly or too slowly. Additionally, this test does not take into account the impact of concurrent medications, diet, health conditions, or personal factors such as age and weight which may influence how medications work.

What is needed to perform this test? Cheek (buccal) cells will be collected by swabbing the inside of your cheeks and gums. Your DNA is then extracted from the swab sample and tested for changes in the MyBestMed™ kit. Instructions for collection are included in the kit.

What will happen to the DNA once the test is complete? The original sample will be discarded at the end of the testing process or stored for not more than 30 days. In some circumstances, your DNA may be used anonymously as a negative or positive control sample in future testing for up to 6 months. But, in this circumstance, all identifiers will be removed prior to re-testing and the DNA sample and results obtained will remain anonymous.

How will I obtain results from this test? Simply log into RxGeneAlert™ and provide your swab serial number and unique validation key. Your results will available approximately 10 business days after receipt of your sample. Your results are available to you and your physician 24/7 through the RxGeneAlert™ portal.

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