Genetic Medicines Test

The Genetic Medicines Test is a simple at-home test that checks for mutations in the genes that are related to how you process certain medications. The results will help your doctor to understand if you are a fast, slow or normal metaboliser of the medication that was prescribed for you. In cases where you are determined to be a fast or slow metaboliser, the doctor may consider adjusting your dose to reduce adverse effects or improve therapeutic outcomes. It is the UK’s first private service of its kind, as well as also being available for US users.

In psychiatry, the selection of antipsychotics and antidepressants is generally led by a trial-and-error approach. The prescribing of these medications is complicated by sub-optimal efficacy and high rates of adverse drug reactions (ADRs). This means your therapy may not be working as expected.

The Genetic Medicines Test can guide your prescriber to optimise the dosing and ensure that therapy is both effective and personalised to you.

We currently test for 2 gene panels to help you understand how the medications you take may interact with them. Our laboratory checks for mutations and has a validated sensitivity of >99%.

The 2 gene panel tests we test are:

• CYP2C19
• CYP2D6

CYP2C19 and CYP2D6 are important drug-metabolizing enzymes that are involved in the metabolism of over 30% of all medications. It covers common drug groups like anti-depressants and anti-psychotics.

CYP2C19 is an enzyme system that is involved in the metabolizing (breakdown) of 5-10% of drugs in current clinical use. The CYP2C19 enzyme system is ‘coded’ by the CYP2C19 gene. About 3-6% of individuals of European & African origin, as well as 13-23% of Asians, have a slow-acting, poor metaboliser form of this enzyme.

The rate of metabolism is important because it determines how your body processes your medication. Some people metabolize a drug so rapidly that the intended therapy may not work as expected; in others, metabolism may be so slow that ‘normal’ doses have toxic effects.

Testing for variants of the CYP2C19 gene can help determine if you are a fast drug metaboliser, normal drug metaboliser or slow drug metaboliser. Individuals who are fast metabolisers, metabolize a drug so rapidly that the intended therapy may not work as expected; in individuals who are slow metabolisers, metabolism may be so slow that ‘normal’ doses lead to toxic or adverse effects.

Knowing your metaboliser status can help your doctor understand if the ‘normal’ dose they had prescribed for you is actually safe and clinically effective for you. The doctor can use this information to personalise your dose or remove the medication altogether. This is a Personalized approach that enables the right drug and dosage to be prescribed based on your genetics.

CYP2D6 is an enzyme system that is involved in the metabolizing (breakdown) of 25% of all prescription drugs. The CYP2D6 enzyme system is ‘coded’ by the CYP2D6 gene.

The rate of metabolism is important because it determines how your body processes your medication. Some people metabolize a drug so rapidly that the intended therapy may not work as expected; in others, metabolism may be so slow that ‘normal’ doses have toxic effects.

Testing for variants of the CYP2D6 gene can help determine if you are a fast drug metaboliser, normal drug metaboliser or slow drug metaboliser. Individuals who are fast metabolisers, metabolize a drug so rapidly that the intended therapy may not work as expected; in individuals who are slow metabolisers, metabolism may be so slow that ‘normal’ doses lead to toxic or adverse effects.

Knowing your metaboliser status can help your doctor understand if the ‘normal’ dose they had prescribed for you is actually safe and clinically effective for you. The doctor can use this information to personalise your dose or remove the medication altogether. This is a Personalized approach that enables the right drug and dosage to be prescribed based on your genetics.

Limiting adverse effects

If there is a change in your DNA that causes the gene to produce fewer proteins then your body could break some medications down slower leading to a higher chance of side effects as the medications ‘builds up’.

Therapeutic Efficacy

If your body is producing too many of these proteins then you might work through medications too quickly to really get a benefit from them.

Genetic Medicines Test results are Life-long results

These results are life-long results. However, as tests change and new genes are researched you may be asked or want to perform further Genetic Medicines Tests in the future. The laboratory reference sheet at the end of the report will be your best resource for determining if other testing could provide benefits.

Benefit outside of initially ordered indication

Some genes, like CYP2D6 and CYP2C19, can provide information on multiple drug classes. For instance, these same genes can be involved in antidepressant medications, opioid pain medications, antipsychotics, proton pump inhibitors and nerve pain medications.

Does not cover all medications

This test does not tell us about all drugs, only certain drugs that are broken down in the liver. Some medications are not broken down and are removed from the body by our kidneys. Others are broken down by enzymes not evaluated by this test

Negative Predictive Test (NPT)

It is possible that the results of the testing will not help you and your physician in managing your care. Even if we narrow down the choices based on the results, it doesn’t guarantee that those medicines will work for you. There may still be some trial and error.

Only one part of the medication selection process

Keep in mind that genetics is one of many factors taken into consideration when selecting a medication. Depending on the medication, drug-drug interactions, kidney and liver function, age, weight and diet, just to name a few, can also play a role.

May not catch rare variations

Genetic Medicine testing does not evaluate the entire gene. We look for changes that are known to affect how you respond to a drug. You may have a change in your genes that we are not looking for. If that happens, you could have a normal test result and still have changes in how you respond to medications. As more research is completed, different tests may be available in the future.

Genes with limited evidence

The Genetic Medicines Test we use gives us the results for many genes. Our clinicians will only make recommendations for genes that have enough research to help us select medications. The genes we do not talk about today may become important in the future as research develops.

Genetic discrimination and protections

If you are concerned about the risks of genetic testing with respect to insurance coverage, we refer you to the UK Code on Genetic Testing and Insurance. This code bars employers and health insurance from discrimination based on genetic testing.

Disease risk

This test does not look at disease risk or other health factors. Genetic Medicine testing only looks at genes and their relation to the response to certain medications.

Our testing is based on CPIC (Clinical Pharmacogenetics Implementation Consortium) evidence. The medications we offer testing on through the service have a PharmGKB Clinical Annotation Level of evidence of 1A, 1B, 2A and 2B and a CPIC level status of ‘final’.

CPIC level A and level B gene/drug pairs have sufficient evidence for at least one prescribing action to be recommended and only those gene/drug pairs that have been the subject of sufficient in-depth review of evidence are given the CPIC assignment level of ‘final’.

For UK users, our German laboratory complies with the fundamental guidelines set out in the quality assurance for clinical laboratory testing by the German Medical Association (Bundesarztekammer). Furthermore, the requirements of DIN EN ISO 15189:2014 are all met and are established in an integrated quality management system based on the certification according to DIN EN ISO 9001:2015 and the requirements of the Rili-BAK (2019). In addition, all consumables used for sample collection are procured in the UK and certified with conformance standards bodies.

For US users, our American laboratory is CLIA-certified and registered with the Pennsylvania Department of Health.

Both the UK and US service utilizes Clinical Decision Support (CDS) software based on the evidence base of the Clinical Pharmacogenetics Implementation Consortium (CPIC).

Yes, this is currently a private service. However, in the UK, this may change and may be funded by the NHS, in the future. In the US, it may be possible it is covered by Insurance but depends on your health plan.

If you complete your health profile, we can assess your medication and see if you are eligible for a Genetic Medicine Test. If you qualify, you will see an alert on the Genetic Medicine Test widget which is located at the bottom of your dashboard. Click the alert on the widget and it will take you to a new screen where you can select the test that you are eligible for, and then checkout. If you miss the alert on the widget, do not worry, we will also send you a notification informing you of your eligibility. This will appear on ‘My Notifications’ on your dashboard.

You can also search you medication directly to see if you are eligible for a Genetic Medicine Test. You can do this from the Genetic Medicine Test widget by selecting the action ‘check eligibility’. You will be taken to a search page where you can look up and select your medication. If you are eligible, we will show you which panels are available for testing. You can then add to the cart and checkout.

You can ‘star’ the Genetic Medicines Test widget to have it display in the ‘My Favourite Widgets’ section of your dashboard, for ease of future booking or checking active or past orders.

Yes. Your medication may be sensitive to both CYP2D6 and CYP2C19 therefore we recommend you have both panels tested. For example, CYP2D6 and CYP2C19 are two clinically relevant genes that can influence how your body metabolizes antidepressants. If you only had one gene panel tested, this would not give you conclusive information about how your body processes the medication you take because the other panel’s influence would be unknown.

Yes. After you place your order and you have successfully checked out, we will send you a Genetic Medicine Test kit. This kit normally takes between 2-3 days to get to you. We will always keep you fully updated with the status of your order including tracking details. Every time the status of your order changes, you will be notified immediately. These notifications will appear in your ‘My Notifications’ section on your dashboard. You can click the notification and it will take you to your active orders screen which will give you a timeline overview of the progress of your order. This can also be accessed using the ‘My Orders’ quick action widget which is on your dashboard. Here, you can access active and past orders.

Instructions for genetic sample collection are enclosed in each collection kit.

We supply you with a return system package. Use this to send back the sample. Samples are fully tracked and can be posted from any Royal Mail post box, for UK customers, or USPS, for US customers.

Test results can take up to 10 working days to process from the day we receive your sample back. When we have processed your results, you will be sent a notification which will appear in your ‘My Notifications’ section on your dashboard, which will advise you that your results are now in the ‘My Documents’ section of your dashboard, however, the test results will be locked and will not be viewable. The notification will include a link that will allow you to book a consultation with one of our pharmacogenetics counsellors.

Once you click ‘Book Consultation’, you will be taken to a consultation booking screen. You will then need to select a date and time that is convenient for you, along with the preferred language of the prescribing clinician you wish to choose. You will then see a list of all available clinicians. From this list, you can filter clinicians by gender and then select the clinician you would like to confirm for your booking. Once you have approved this, you will see a summary of the appointment including preliminary information about the consultation. At this point, you will also be able to add a reminder to your calendar. Always ensure your account health profile is up to date before any consultation. This ensures that our clinicians have the most up-to-date information about your current health status and anything that may influence their prescribing decisions. You will receive a push notification and email reminding you of your consultation, 30 minutes before it is due to start.

At the consultation, the clinician will discuss what the results mean for you and the medication you are currently taking. If the clinician decides that your doctor may need to review your medication or dose, they will send a referral letter, including the test results, to your doctor. If the clinician decides the results do not affect the way you process your medications then the consultation will end.

At the end of the consultation, you will receive a notification which will summarise the outcomes of the consultation. It will also advise if a doctor referral was made, by way of letter. If a GP referral letter was issued, you will be able to view a copy of this in the ‘My Documents’ section of your dashboard. At this stage, your test results will also be unlocked and you will be able to download it and share it with any other healthcare provider.

Yes, we follow strict General Data Protection Regulations (GDPR) which came into force in May 2018. This places legal requirements on ourselves to ensure your personal data is managed securely with utmost confidentiality. Records are maintained of the processing that is carried out and reported when breaches of the regulation do occur. Our platform is also HIPAA compliant which means we are able to handle PHI (Personal Health Information) securely.