DNA test
Preparation
Do I need to do anything to prepare for a DNA test?
Yes! All of the DNA tests promoted by Merogenomics are medical tests and need to be considered seriously. As a consequence, Merogenomics strongly recommends you familiarize yourself with the background documentation of your test of interest and the overall implications of DNA testing as much as possible prior to committing to undergoing DNA testing. Studying the Merogenomics website is an excellent start.
Furthermore, Merogenomics aims to educate each client about DNA testing and informed consent. It is advised that you contact Merogenomics prior to any DNA test purchase to receive the fundamentals on topics that need to be considered for informed consent with regards to DNA testing. Each client will also have the option of an in-person, free consultation with a Merogenomics representative after familiarizing themselves with this vital supporting documentation provided by Merogenomics. When you sign the test requisition form that comes with the DNA test kit, that will constitute your informed consent that you agree to DNA testing. We want to make sure you fully understand the benefits and limitations prior to that signature.
We also recommend that you compile your family medical history, in as great a detail as possible and we recommend tracking this information in the form of a pedigree (a visual family tree). This is very valuable resource for any family and their treating physicians and such information will be invaluable for all of the DNA tests promoted by Merogenomics. Such content helps identify whether specific conditions could be heritable, which can also be important for DNA test coverage justification (for example, under the Private Health Services Plan which includes Health Spending Account or Cost Plus Plan if you are a business owner). Finally, in the event that the DNA test discovers pathogenic mutations (those that can lead to disease development), the collected family history will also be of great importance to a genetic counsellor.
Selection
How do I choose the best test for myself?
To make finding your primary selection simple, we first divided our tests based on four target groups in which to easily identify yourself. Once you select your group of interest, further test selection might depend on the required need for testing. For example, cancer target groups can be divided into tests for affected cancer patients versus tests for asymptomatic individuals with family history of cancer. In other circumstances, more than one option might be available to you - for example, gene panels versus a full genome sequencing. At that point, the selection of the best test will be a personal preference. At that point, a Merogenomics expert will ensure that you get all the guidance to make the best-informed decision and fully resolve any questions you might have before making your personal decision. Please contact Merogenomics for further clarification.
How are Merogenomics’ approved tests different from online options like 23andMe?
Mostly, online tests, which do not even require a doctor’s participation, are hardly medically relevant and many of these tests claim to provide “health related” information but instead just provide results on genetic conditions that are not validated for accuracy and thus are speculative at best. 23andMe is a notable exception which can provide some verified results. Still, one needs to understand that a 23andMe test is very limited and looks at only a very specific location within the DNA and does not scan any other DNA content. As a consequence, 23andMe test results provide a very narrow view of genetic information. The tests that Merogenomics promote scan either entire genes or the entire genome (all of the DNA) and therefore capture widespread and extensive amounts of your genetic information. Furthermore, the tests promoted by Merogenomics are designed and accepted for clinical use - to be used by doctors. 23andMe and the vast majority of online tests are not meant to be used to guide medical decisions.
Requirements
Are there any restrictions on or conditions for purchasing a test?
You will require a doctor to participate. You can either select one of our participating clinics that will help provide a doctor to oversee your DNA testing results, or you can select a doctor of your own choosing but then you will need to make separate arrangements through Merogenomics first by booking a consultation.
You will also be required to obtain some background knowledge in what represents informed consent when consenting to a DNA test as we put a great emphasis on client education. We will provide you with a short checklist of topics we consider essential for your overview - this checklist will be reviewed by the participating clinics prior to providing you with a DNA test kit. Don’t worry, this is not much information, but essential information.
Minors cannot purchase the test, and you cannot purchase the test for someone else unless you are the legal guardian of the individual to be tested.
With the exceptions of full genome sequencing (which you can use for proactive screening of your genetic health status) and non-invasive prenatal testing (that you can use for proactive screening of the genetic health of your developing fetus) all other DNA tests promoted by Merogenomics require some medical indication for testing.
Security
Who owns my information and how is it secured?
Your genetic information belongs strictly to you. This means that any data generated from your DNA testing belongs legally to you. Nearly all of the companies promoted by Merogenomics will securely store your DNA data in their database for your future reanalysis (as might be requested by you), and you can even request for the data to be deleted at any time. You can also request for the data to be transferred directly to you which Merogenomics highly recommends.
Currently, all of the companies with which Merogenomics interacts are US based and abide by HIPPA regulations. All of the companies that Merogenomics promotes work with patient data for clinics and hospitals around the world and are highly qualified for patient data protection. This is one of the most significant conditions that needs to be satisfied when delivering DNA testing in a clinical setting. This is also the reason why Merogenomics strongly recommends only doing DNA testing for medical oversight using clinically approved DNA testing.
Finally, and very importantly, genetic data is protected from unauthorized scrutiny in Canada and furthermore, cannot be requested by any person or organization for the purpose of delivering any goods or services (Bill S-201). This means that no one is allowed to request your genetic information without your consent and cannot demand such consent on the threat of not delivering a service. This includes employers and insurance companies.
Protection of your genetic information is your legal right in Canada.
Process
What do I get for my payment?
The purchase of the DNA test entitles you to the following:
- DNA test kit for sample collection
- CLIA-certified laboratory sequencing of your DNA isolated from the sample provided
- State of the art medical interpretation of the DNA sequence
- Report delivered to your ordering physician
- Online access to test results details for your ordering physician
- Option of downloading your DNA sequence (this will require additional consent and may require an additional fee)
- Secure storage of your DNA sequence (not available for the non-invasive prenatal testing) for future interpretation
- Tracking of flagged variants of unknown significance for interpretation of a status change (reported to the ordering physician in case a status change takes place)
- Option of re-interpreting your stored DNA sequence at a future date (additional fee will apply, available for certain tests only)
- Free family testing if pathogenic results found (time limit applies, available for certain tests only, testing applies only for the identified pathogenic mutation)
In addition, we offer free educational information and the first 30-minute consultation without any charge.
What is the process of a DNA test purchase?
Prior to your purchase of the DNA test, we at Merogenomics endeavour to provide you with enough key information about the DNA test to facilitate proper understanding and informed consent to go ahead with DNA testing. We put a high emphasis on enabling our clients to be well prepared and well educated about any DNA testing that may have serious medical implications.
Each client will always have the opportunity to take a short, in-person consultation with a Merogenomics representative to clear up any concerns or additional questions.
You have two ways of purchasing a DNA test from the catalog of services promoted by Merogenomics. One option is to purchase the test online by selecting one of the participating clinics. If you select your own doctor, you will have to book a meeting with Merogenomics for alternative payment options.
If you decide to purchase the test online, your payment is processed by our Website, and you will obtain a receipt of the DNA kit purchased for the designated clinic you selected.
Merogenomics will also provide you with a short checklist of informed consent educational topics that indicate to the test ordering physician that these important background topics have been covered.
Your purchased DNA kit will be available for you at the clinic you selected. The clinic will oversee the handing of your DNA kit and will either collect the sample from you (blood or saliva) and ship the kit to laboratory for processing. However, not every clinic might have a nurse on staff to collect a blood sample. If the clinic is not equipped to handle sample processing, you would be provided with the kit to go and collect the blood sample in a different location. If you have to be directed to another clinic for blood collection, some fees may apply. The kit will then need to be delivered to a courier for shipping. Merogenomics is available for assistance at every step in the process.
However, the majority of DNA tests will suffice with saliva sample collection.
Once the kit is in a laboratory, DNA will be isolated from the sample you (or your dependent) provided, the DNA will be decoded, and the obtained DNA sequence will be interpreted for medical information. Your ordering doctor will obtain the DNA test results and book an appointment for consultation so your doctor can discuss with you your results and potential management strategies.
Kits
What if my kit expires?
We will issue you a new kit at a cost of $50. In the unlikely event that you were issued a kit that was to expire in 30 days or less, we will issue you a new DNA test kit at no charge.
Results
What kind of results could I obtain?
In general terms, there are three types of results. There could be positive results, meaning a genetic condition was identified. There could be negative results which means no genetic information was found. Or there could be no results meaning the test is inconclusive.
Positive results
Within the positive results category the DNA mutations, more properly referred to as DNA variants, will be categorized into three classes:
Pathogenic variants – these are DNA mutations that are clearly established to have links to health conditions. Such information is always reported to your doctor for the development of a proper health management response (in association with your personal health history that is available to your doctor).
Likely pathogenic – these are DNA mutations that are very strongly suspected to lead to health conditions but do not have the same level of evidence as the above. These are also always reported to your doctor.
Variants of unknown significance (VUSes) – these are DNA mutations that do not have clear, established links to health conditions and their potential health impact is not understood yet. These are almost never reported to your doctor. VUSes are analyzed with predictive outcome computing tools to learn to understand their potential biological impact. If such modeling appears to indicate a potential negative biological impact and that the gene affected by the VUS appears as if it might be linked to a patient’s presented symptoms - then in rare instances such a VUS will be reported to your doctor. However, in this case, doctors are not expected to make medical management decisions, and they are strongly discouraged from doing so by published guidelines. The VUSes are just reported for monitoring purposes. Usually the companies that flag such VUSes will then monitor the incoming medical research data related to such a VUS in case the it is upgraded to be a pathogenic or likely pathogenic variant. At that point, the ordering doctor is notified of such change and medical management can begin.
Negative results
Within the negative results category, it first needs to be understood that just because no pathogenic or likely pathogenic mutation was uncovered, that does not mean that one does not exist although, the likelihood of missing a true pathogenic event (false negative) decreases with the increased power of investigated content. For example, online limited 23andMe tests only look at certain mutations in certain genes related to health. This means that every other site that is not investigated in those genes could also have a pathogenic mutation and so such information will not be reported and thus missed. In contrast, Merogenomics promotes tests that look at either the entire genes or the entire DNA content of a person (full genome). And even within these very thorough tests, there could still be other additional pathogenic events that cannot be captured just by decoding the DNA sequence. Currently even the best medical tests in the world, which is what Merogenomics has assembled in its catalog, will each have its own limitation of detection.
However, it must be stressed that the greater the power of investigation of a given DNA test, the less likely that important pathogenic event has been missed.
No result
Finally, a no result could be obtained due to technical failure which is extremely rare for germline DNA tests, or the tests that probe your inherited DNA. Failure is more likely when assessing different types of DNA that might not be available in abundance, such is the case in non-invasive prenatal tests or somatic cancer DNA tests. Merogenomics promoted tests are some of the best tests in the world and have some of the lowest documented test failure rates. This is especially important in selection of the non-invasive prenatal test, as test failures, which are often not stated by service providers, increases the likelihood of needing a confirmatory invasive testing (such as amniocentesis) which can have associated risks with it.
How do I obtain my results?
You do not obtain your results directly. Only your ordering physician will obtain the results. Your doctor will book an appointment with you to follow up with you on your genetic results. Your doctor also will gain access to an online portal that examines your DNA information and its interpretation in detail, depending on the test ordered. Sometimes, this can include much more information than issued in the report, which is made to be concise and medically relevant. This applies to tests related to exome and full genome sequencing. It will be up to the doctor if they will agree to provide you with that content.
How predictive are the results?
The answer to this depends on how predictive value is measured. Some companies might aim to answer this question by saying that the accuracy of obtained DNA code information is very high and therefore has a very high predictive value.
However, traditionally predictive value refers to the ability of the test to predict clinical outcomes. The predictive power of a DNA test can be extremely broad, depending on the mutation uncovered. It can range from nearly 100% to very low numbers in the single digits. This is because a DNA mutation in itself never has to guarantee an outcome due to additional factors that might influence how the condition may or may not manifest itself. This is referred to as disease penetration. For example, same identical DNA mutations can have dramatically different outcomes in different individuals where one person might exhibit only mild symptoms and another can exhibit very severe symptoms. Many factors can influence these outcomes that would not be captured by the DNA test. Even other additional DNA mutations found in the same individual could be influencing the final outcome without anyone fully understanding how the degree of the disease penetration will be affected.
Notwithstanding that, the DNA tests promoted by Merogenomics include only validated information for DNA mutations that are known to have resulted in medical conditions.
The predictive value is also affected by the rarity of the identified DNA mutation.
Doctor selection
Selection
Why does a doctor have to be involved?
The DNA tests that are promoted by Merogenomics are all for medical use, and as a consequence it is a requirement from all of the DNA testing service providers. The only exception is the pharmacogenetic test (looking at DNA to learn about personalized medication use to determine drug dosage or toxicity) which can also be ordered by a pharmacist. The purpose behind this is to protect the client from misuse of DNA information as there are many tests out there that promote health related aspects without any actual validity behind their clinical utility.
Can I use my own doctor or do I have to use the listed clinic?
You can use your own doctor as opposed to selecting one of the participating clinics. However, you will need to contact Merogenomics for special arrangements for payment and DNA kit shipping.
Does it matter which participating clinic I choose?
It is your choice, although different clinics could be offering different DNA test options. In addition, the same DNA test offered by different clinics could have different prices. Some clinics will offer the option of blood sample collection which can simplify the procedure for you. A final consideration that could influence one’s decision might be as simple as the geographical location.
Test kit pick up
How do I get the test once I purchase it online?
If you purchased the DNA test online and chose one of the participating clinics, the test will be waiting for you at the clinic. You may want to call the clinic to confirm: that there are DNA test kits in stock; if the DNA test kit requires blood sample collection, to determine if the clinic offers blood collection services; and to book an appointment with the DNA test ordering physician at the clinic. Your next step is to bring your bill of payment and your checklist of completed educational topics about informed consent which the clinic will copy for its records. The clinic will start the kit processing by having the ordering doctor fill the kit test requisition form (that will also need be signed by you), and depending on the nature of the kit, the sample for the DNA test will be collected (either saliva or blood, depending on the test type). If a blood sample is required (such as for the non-invasive prenatal test), but the clinic does not process blood collection, you will need to arrange separate visit with a blood collection site (such as DynaLife, additional fees will apply). For ideal results, ensure the DNA kit with collected sample and filled out and signed test requisition form is shipped to a processing laboratory the same day as the day of sample collection.
Shipping (conditional only)
When
When are kits shipped?
Kits are shipped either to participating clinics so they are immediately available for pick up by the purchasing client, or they can be shipped to a specifically requested address (individual’s home or individual’s treating physician’s clinic) if the client prefers to use their own doctor as opposed to relying on the partnered clinics doctors for test oversight. If a kit needs to be sent to you or your doctor, you will need to make special arrangements with Merogenomics.
How long will it take for the kit to arrive at the clinic?
DNA test kits usually should arrive within seven business days.
Charges
What are the shipping charges?
DNA test kits are free to be shipped to the receiving address. They cost of shipping back is also covered with prepaid shipping label included in the DNA test kit.
Locations
Do you ship overseas?
The companies that Merogenomics works with are all American based with global outreach and ship DNA test kits internationally. Please contact Merogenomics to determine if a given DNA test can be made available to you in your country and if we can make any special arrangements for shipping.
Payments
Currency
Can I pay in a different currency?
All prices are currently only in Canadian dollars.
Taxes
What taxes are paid on the test?
5% goods and services tax (GST) is applied on all DNA test prices. No additional taxes are applied from Canada.
Payment methods
What payment options are available to me?
For DNA test purchase online, all major credit card payment options are available, as well as PayPal. When the DNA test is selected to be shipped to a specific requested address, additional payment options can be available such as money transfer or cheque.
How could I pay in installments?
Financing options can be made available for any Canadian clients, provided that the interested client is approved. Financing is made available by an independent third party. Loan interest will apply.
For all full genome options, Merogenomics clients also have an option of paying for the test in 6 monthly installments with no interest. This option is not available for online payment, and special payment arrangements will have to be made. Please contact Merogenomics for further information.
Security
Who collects my payment information data?
We use Shopify as the payment processing entity that collects and protects the financial information. Merogenomics does not get access to the financial information of the client.
Returns
Return policy
Can I return the product?
You have 30 days to get a refund minus a processing fee of $50 to cover the cost of the DNA test kit that has been purchased online. Returns are no longer available if your sample has been shipped and received by the laboratory for processing. Any additional fees you might incur (such as blood sample collection by third party clinic) that are independent of Merogenomics are not considered for a refund. Only the cost of the DNA test can be returned.
Legal