FAQ: Pharmacogenomics for Healthcare Professionals

Based on the patient’s genetic results, you will receive notifications on their potential effects for the medications covered by the test. You will be notified if a dose adjustment should be considered, if you should look out for specific side effects, or if certain medications have a higher likelihood of better or poorer response.

People react differently to medications and the Biron PGx test helps predict how a patient’s response may differ from what is normally expected. While the test does not supersede clinical judgement, it does provide doctors with valuable information they can use to make PGx-guided decisions and improve the likelihood of prescribing the right medication at the right dose.

The main goal of our PGx report is to help clinicians find the right medication and the right dose faster than using an iterative trial-and-error process. The patient’s genetic data can guide you toward the best treatment options and away from medications that may be less compatible with the patient’s DNA, thereby speeding up recovery.

The Biron PGx test can benefit patients who are dissatisfied with their current treatment, as well as those who are about to start a new pharmacotherapy. Here are examples of situations where the test may be useful:

• The patient fails to respond adequately to medications recommended by current clinical guidelines.
• After one failed treatment due to side effects, to reduce the risk of further harm and to reassure a patient that is reluctant to take a medication due to fear of side effects.

The Biron pharmacogenomic test analyzes genetic variants that influence the effects of medications used in psychiatry and pain management. Our test tells you whether these variants are present, as well as their potential impact on response and tolerability to more than 135 medications used in psychiatry and pain management, including those used to treat ADHD, depression and anxiety. You can review our complete list of genes and drugs covered by the test.

No, we do not sequence the entire genome as this method gathers too much information and goes beyond the scope of pharmacogenomics. We use a technique called genotyping, which limits the analysis to a list of variants that were selected based on available peer-reviewed literature supporting their influence on drug response.

Consequently, we do not detect variants of unknown significance (VUS) and cannot use these results to determine the risk of hereditary diseases.

Genetics can affect the pharmacokinetics and pharmacodynamics of medications.

In pharmacokinetics there are there four main steps: absorption, distribution, metabolism and elimination. However, the vast majority of pharmacogenomic studies that support an effect of genetics on drug levels involve metabolism and distribution. The CYP450 enzymes have received the most attention, for example CYP2D6, which is responsible for metabolizing many psychotropic and pain medications.

On the other hand, pharmacodynamics concerns the effect of a medication on the organism. This type of genetic variability can be predictive of drug response and a predisposition for particular side effects, independent of dosage. In short, pharmacokinetics deals with drug levels, while pharmacodynamics deals with efficacy and the predisposition for side effects.

Please refer the patient to the information page at biron.com/pgx, which is found on the requisition form, or provide them with a Patient Pamphlet.

All of the recommendations included in our reports are derived from peer-reviewed scientific publications. Some recommendations may also come from drug labels approved by Health Canada and other organizations such as the Food and Drug Administration (FDA) and the Clinical Pharmacogenetics Implementation Consortium (CPIC). Biron ensures that the information in your report comes from credible scientific sources that have expertise in the field. To review the methodology we used to establish our evidence and determine which variants to include in the report, you can refer to the document on evidence-based pharmacogenomic testing for psychiatry and pain management.

The PGx report contains interpretations of genetic results based on peer-reviewed articles and guidelines. Each interpretation is given a score indicating the strength of the evidence supporting the recommendation. Since pharmacogenomics is an evolving science, the Biron pharmacogenomic test is periodically reviewed and updated to stay current and relevant.

Genetic results do not change over time. Whether the patient takes the test at the age seven or 70, the results remain the same. However, science evolves and it is likely that interpretation of the results will change over time. As such, the report will be updated at no additional charge, to ensure that doctors have the most current and scientifically sound information available for guided treatment. Additional charges may apply if further genetic testing is required.

Many factors influence a person’s response to medications, including diet, exercise, diagnoses, comorbidities, etc. Genetics is also a factor that influences the effect of medications. However, these factors are present regardless of whether a patient undergoes genetic testing. Therefore, following the recommendations in the report does not eliminate the possibility the patient may not respond well to certain medications. Nevertheless, these recommendations will reduce the risk of unwanted side effects and increase the chances of finding a safe and effective treatment sooner than if the patient had not taken the test.

The genetic analyses on which recommendations are based are validated and 99.99% reliable. We validate our laboratory analyses using control samples with known results.

We offer a comprehensive test that identifies common and rare variants across multiple ethnic backgrounds.

One limitation lies in the technology to detect the genetic variants used in the test. Since the preferred method is genotyping, there is always an intrinsic risk of false negative results. In other words, in the rare occurrence that a patient carries a new and undocumented genetic variant, this will not be detected.

The role of genetics in the patient’s overall response to a medication is another limitation. Diet, drug interactions, diagnosis, comorbidities, etc. are factors that can also contribute to the response. However, since PGx results do not change over the course of a patient’s life, the genetic code can be taken as a constant among the other variables.

Biron is an independent company that has no affiliation with the pharmaceuticals industry. Recommendations for or against a medication are solely based on the patient’s genetic results and are in no way influenced or motivated by a need to promote a particular medication. Our mission is to generate more positive outcomes by addressing the problems of trial and error and reducing the number of therapeutic failures experienced by many patients.

Of the 145 drugs evaluated by Biron's Pharmacogenomic test, 16 are marked as such. Nevertheless, we include them because they are among the drugs used in mental health and pain management. We conducted a literature review and determined that, for the time being, no PGx recommendation can be made. It is important for the physician or pharmacist to know that the drug has been evaluated and not forgotten. In the future, as science advances, recommendations may be added for these medications.

The patient’s genetic data is encrypted on multiple levels and stored in Canada on servers that meet or exceed the most stringent security standards. Biron protects genetic data by letting the patient control who has access to their information.

Test results are never shared with a third party without the patient’s consent. Whether it is a healthcare professional, an insurance company or a family member, Biron requires the patient’s consent prior to sharing any results.

Patients are not required to inform any insurer that they underwent a genetic test, nor can an insurance company request or obtain genetic results from Biron. The federal government’s Bill S-201 aims to prevent and prohibit discrimination based on genetic information.

No, this test is not a diagnostic tool. It is intended to support and guide clinicians in deciding on optimal treatments for their patients.

To prescribe a PGx test, complete the requisition form and give it to your patient. The requisition will direct the patient to biron.com/orderpgx, where the test kit can be ordered for home delivery.

You can also choose to keep an inventory of kits in your office, prescribe the test and assign a kit directly to your patient. You will be asked to initiate the kit online for your patient, using the activation sheet included in the box.

Whether or not you keep an inventory of sampling kits at your clinic, please refer to the appropriate scenario described in the instruction sheet “How to assign a Biron PGx test to a patient”.

To order the test online, the patient can provide a requisition signed by their attending physician, and then scan the QR code on their prescription or visit biron.com/orderpgx.

Yes, if you keep inventory at your clinic, make sure to provide the patient with a requisition signed by their physician, along with a sampling kit, and then ask them to follow the instructions included in the box.

If the kit is assigned to a patient at the clinic, you should activate it as though you were the patient. If the patient is under the care of a parent or legal guardian, then activation should be done as though you were the parent or legal guardian.

You should only choose the “Activate the kit for a patient with a legal guardian” option if the patient is under the care of a parent or legal guarding, so that the report is available to the parent or legal guardian.

The Mental Health (Psychiatry & ADHD) OR Pain Management pharmacogenomic test costs $349, including delivery. The Complete Mental Health (Psychiatry & ADHD) AND Pain Management test costs $499. Some insurance companies may reimburse a portion or all of this amount.

Coverage for genetic testing depends on the patient’s private insurance and plan. A prescription may be required. If so, make sure the prescription states “pharmacogenetic test” or “pharmacogenomic test.”

A healthcare spending account within a private insurance plan may also cover the cost of this test. For more information about their coverage, we recommend the patient contact their insurance company.

No. Taking any prescribed or non-prescribed product does not affect the pharmacogenomic test. In any case, we do not recommend they stop or change their current treatment without approval from their healthcare professional. The patient is therefore advised to continue any treatment as recommended.

It is important not to drink, eat or smoke within 30 minutes before providing the sample, to ensure the saliva is clear. They should also wait 30 minutes after brushing their teeth.

There is no minimum age to perform a pharmacogenomic test, however, we recommend that you take the test once the medical condition to be treated has been diagnosed.

They will find detailed instructions in the sampling kit and in the FAQ for Patients, including a link to an instructional video.

It takes about one week from the time the sample arrives at the Biron laboratory until the results are delivered to the attending physician.

Once the PGx report is ready, you receive a notification by email, usually about five business days after the sample has been received at the lab. Please refer to the instruction sheet “How to retrieve the PGx report.”

Once the report is delivered to the physician, the patient should meet with their doctor to discuss the results and any related recommendations. Biron can share the report with the patient upon request.

The PGx report was developed for clinicians and in collaboration with them. The result is a straightforward report that you should find intuitive and easy to read. However, if you need help navigating the different sections, you can refer to the “Guide to using the PGx report.”

You can also contact our experts in pharmacogenomics at any time: 1-866-923-9222, ext. 8702.

If any component of the Biron PGx kit is missing, you can notify our Pharmacogenomic Support team by email (pgxinfo@biron.com) or by phone (1-866-923-9222, ext. 8723). We will provide you with instructions and the missing item.