Pharmacogenetic panel (cancer)
A pharmacogenetics panel DNA test assesses specific DNA code sites for an interpretation related to medication dosing or toxicity. Please view further details to see which medical specialties may be involved.
In order to obtain the DNA testing kit under medical supervision (required), the purchased test includes a bill to be presented at your selected clinic. Test prices can vary between different medical clinics. PATHOGENIC RESULTS WILL REQUIRE A GENETIC COUNSELING SESSION PRIOR TO MEDICAL MANAGEMENT.
Clients will also be given a checklist of topics to facilitate informed consent. Test purchase should take place after consultation with a Merogenomics representative in order for the client to be best prepared for informed consent. Informed consent and education towards its understanding will be required by the clinic. IF YOU HAVE NOT CONSULTED MEROGENOMICS ABOUT YOUR DNA TEST PLEASE BOOK A FREE APPOINTMENT USING THE LINK BELOW PRIOR TO TEST PURCHASE!
All international or Canadian clients in a region without a supported medical clinic, please book a meeting with Merogenomics to discuss the use of your preferred local doctor.Pharmacogenomics is the study of the variability in drug responses due to heredity. Pharmacogenomic panel sequencing is the process of decoding the order of nucleotide bases in specific DNA sites of selected genes which are currently known to be associated with drug metabolism, transport, mode of action or risk of adverse effects. Variants (changes) observed in the DNA between different individuals afford insights into the variations in medication dosing or toxicity.
- A pharmacogenomic panel analyzes specific DNA alterations (genotyping) that are associated with validated effects on personal responses to medication
- This test is used for clinical purposes and should not be regarded as investigational or for research
- The test must be ordered by a medical doctor or a pharmacist who will oversee the clinical report based on the DNA sequence interpretation
- The test is for oncology patients interested in genetic diagnosis only in relation to how it impacts their response to medication, including cancer treatment therapies such as chemotherapies, targeted therapies, and medications used in supportive care for conditions such as nausea, vomiting, pain, anxiety, depression, sleep deprivation, and for antimicrobial use or the use of multiple medications. In total, the test provides information for over 300 medications also used in the treatment of the following conditions: acute migraine, ADHD, allergies, Alzheimer’s disease, anticoagulation, antiplatelet therapy, arrhythmias, benign prostatic hyperplasia, chronic hepatitis C, diabetes, dyslipidemia, gastroesophageal reflux disease, gout, HIV infection, hypertension, immunosuppression, migraine prophylaxis, overreactive bladder, Parkinson’s disease, psychosis, rheumatoid arthritis, seizures, and smoking cessation
- The test report provides information on gene-drug interaction, and is categorized based on the expected impact, which ranges from limited to major gene-drug interaction
- The test is for cancer patients who:
- Plan to initiate cancer treatment with certain chemotherapies or targeted therapies
- Used medications without beneficial results
- Use multiple medications
- Experienced unwelcome side affects from medication
- This test is not used to diagnose any other inherited suspected genetic conditions. Please refer to the “Full genome sequencing” option for a screening test for the most comprehensive overview of alterations in an individual’s DNA code, including cancer predispositions, genetic disease risks, pharmacogenetics information and carrier status. However, the pharmacogenetic test covers four genes which results may be linked to disease-risk. These include: factor V (F5) Leiden thrombophilia, prothrombin (Factor II or F2) thrombophilia, Gilbert syndrome and dihydropyrimidine dehydrogenase (DPYD) deficiency. It is possible that the test results may also provide a probabilistic risk of these diseases
- This test is not for the DNA analysis of tumor samples. Please refer to tumor sequencing test options for more information
- Anonymized patient/client clinically-relevant information will be included in public databases to help with the future medical analysis of human genomes. Databases contain cumulative results from around the world and do not include information that can personally identify the patient/client
- The test can be paid for directly by the patient/client. Interest-free payment plans are available. Insurance billing is available and can be investigated up-front to determine out-of-pocket expenses. Institutional billing is also available for organizations that prefer to bill patients/clients directly
- Merogenomics provides background education towards patient/client informed consent
- The collection kit can be for a saliva or blood sample, with prepaid shipping included
- Services are fully insured, and are HIPAA, CLIA and CAP compliant
- The results are available within 10 days
- A concise clinical report is delivered to the ordering doctor only, and then subsequently discussed and shared with the patient/client. The report lists variants associated with the increased risk of affecting an individual’s response to specific medications
- The ordering doctor will obtain their own personal login to the web console in order to have direct access to all of the data
- The databases used for DNA sequence interpretation are regularly updated, and novel pharmacogenetic findings pertaining to analyzed variants identified in a patient/client will be delivered to the ordering physician for the duration of DNA data storage by the company
- Complimentary post-test genetic counselling is offered
- Fine-tune the dosing of certain chemotherapies and targeted therapies to avoid or minimize toxicity
- Guide medication decisions for comorbid conditions related to cancer treatment
- Prevent unintended interactions between drugs
- Improved medical compliance due to the reduced chance of adverse reactions
- The test results can be used continuously in the future treatments over the course of the patient/client’s lifetime for over 300 medications
- Patient/client data is securely stored on cloud for subsequent re-analysis
- The entire process closely follows the Canadian and American guidelines, therefore there is a high level of proper accountability for the clinic
- Biological sample quality can influence the scope and quality of the final decoded DNA sequence data, and therefore its interpretation
- If a new gene or a variant is added to a panel, previous information cannot be updated for that particular gene or variant if the patient/client has not been tested for it in the first place. Therefore to capture any novel DNA sequence information, the patient/client would have to retake the test
- It is possible that previously unidentified variants with clinical implication might be present in the selected genes that are not investigated by the test due to an incomplete DNA sequence analysis, therefore a negative result cannot rule out the possibility that the patient carries an unexamined mutation
- False positive results can occur and all clinically relevant identified alterations are recommended to be validated by separate technology
- The test does not differentiate duplications in the presence of a deletion
- The test does not detect alterations which are not caused by a change in the DNA sequence, such as gene expression, epigenetic modifications, fusion, or chromosome conformational changes
- The interpretation will be limited to the current state of scientific knowledge of how DNA changes lead to drug responses. This scientific knowledge can also contain mistakes
- Samples cannot be accepted if the patient/client has undergone an allogenic transplant such as bone marrow or a peripheral stem cell transplant. A history of hematological disease might exclude test availability in certain circumstances
- The test has not been cleared or approved by the US Food and Drug Administration. The FDA does not require this test to go through a premarket FDA review
- All tests offered through Merogenomics require a physician to sign a test requisition for regulatory compliance reasons. A pharmacogenomic test can also be requested by a pharmacist. Once the requisition form is signed by the doctor, the ordering doctor does not have to participate in the process until the receipt of the test results
- Merogenomics can provide detailed background information to the ordering physician about the test process. Merogenomics also provides background education towards patient/client informed consent
- The test results should be interpreted in context with any other available patient/client clinical findings
- It is recommended by sequencing guidelines that the patient/client undergoes genetic counseling prior to and after clinical DNA testing
- The DNA sequencing and interpretation takes place in a CLIA/CAP certified laboratory
- Patient data is HIPAA compliant, which is securely stored on cloud for continuous re-analysis, and is never sold or shared with third-party companies
- The ordering physician or pharmacist can select medications that are most relevant to the particular patient/client for added focus, including dosing guidelines and potential medication alternatives
- The ordering physician or pharmacist will be the recipient of the genotyping analysis clinical report. The patient/client will not obtain these results independent of the ordering physician. Merogenomics will not have access to the patient/client report, but can review the report after the receipt of the data if requested by the patient/client
- The ordering doctor/pharmacist obtains their own personal login to the diagnostic web console with access to all of the data, in order to:
- Interpret the test results
- Obtain detailed information about all of the medications in the database
- Evaluate drug-to-drug interactions as related to the patient
- Identify alternative medications for the patient
- Analyze medications based on specialty, indication, or the patient’s medical history
- Generate custom reports
- The report is designed with doctors in mind and will be divided into the following sections:
- The first page will list the symbols that are used in the report
- A summary of personalized medication pre-selected by the ordering physician (optional)
- All medications organized by specialty and classified based on the severity of the predicted gene-drug interaction
- Hyplotype/genotype results along with the predicted drug phenotype impacts
- The patient/client’s entire genotyping results that make up the analyzed hyplotypes
- The final page is devoted to the methods of testing and the limitations of the procedure
- Samples cannot be accepted if the patient/client has undergone an allogenic transplant such as bone marrow or a peripheral stem cell transplant or liver transplant. A history of hematological disease might exclude test availability in certain circumstances
- Samples cannot be accepted if the patient/client is experiencing kidney or liver failure
- For cancer patients undergoing chemotherapy treatment, the DNA quality may be affected if the patient has received treatment in the past 120 days, potentially requiring sample resubmission
- The service provider’s clinical pharmacists can provide information regarding test results to the ordering doctor
- PCR-based genotyping and copy number variant analysis run on an IntelliQube qPCR Platform using Thermo Fisher TaqMan® and/or LGC Biosearch BHQ® probe-based methods
- Possesses over 99.9% sensitivity
- Proprietary methods identify and analyze the following types of variants (depending on the gene investigated):
- Small sequence changes
- Single nucleotide variants (SNVs, alterations that affect only one nucleotide at a time, also termed single nucleotide polymorphisms or SNPs)
- Insertions and deletions (indels under 50 bp)
- Structural variants (DNA alterations that affect large segments of DNA of more than 50 bp, and can include insertions, deletions, or copy number variations or CNVs: the duplication of a particular DNA segment)
- Small sequence changes
- A proprietary haplotyping algorithm is used to convert genotypes to haplotypes
- For clinical genes with related pseudogenes, sequencing is performed to confirm the mutation presence in the gene of interest and not in the pseudogene
- Only drugs which fit the highest level of published clinical validity (level 1 or level 2 of PharmGKB database) are included in the bioinformatic analysis
- Genes investigated: COMT, CYP1A2, CYP2B6, CYP2C cluster, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP3A5, CYP4F2, DPYD, DRD2, F2, F5, GRIK4, HLA-A, HLA-B, HTR2A, HTR2C, IL28B (IFNL4), NUDT15, OPRM1, SLC6A4, SLCO1B1, TPMT, UGT1A1, VKORC1
- MTHFR gene analytical analysis can be added at no additional cost if requested by the ordering physician
- Volume discounts are available. Contact Merogenomics for more details
Clinical DNA testing is not a simple straight-forward process compared to commercial, direct-to-physician genetic testing. As a consequence, there are stringent guidelines and criteria that need to be fulfilled in order to ensure that the results of the test, as well as the managing parties involved, are all compliant for subsequent medical oversight.
- The client/patient has a consultation with Merogenomics to fully understand informed consent for Clinical DNA testing.
- All DNA tests promoted by Merogenomics require a doctor to sign a test order. The client/patient can select one of the clinics for DNA testing. This selection allows for online test purchase. Alternatively, any physician can order the test for a client. Merogenomics can provide background about the desired test to any physician interested in signing the test requisition form. For independent doctors, you will need to book a FREE consultation.
- The client picks the DNA test of choice offered by the selected clinic. Alternatively, any DNA test can be selected if ordered by independent doctor.
- The client/patient will have the option to purchase the test in full or apply for financing. An invoice is issued to the patient on behalf of an ordering doctor/clinic, allowing the patient to proceed to a clinic to receive the DNA test kit. The DNA test kit can only be obtained upon proof of payment.
- For independent doctor orders, the invoice can be issued from the DNA test provider.
- The doctor must sign the test requisition form. The ordering doctor is also the doctor who will receive the DNA test results.
- The biological sample containing the client/patient’s DNA must be collected (blood or saliva, depending on DNA test).
- For blood collection, the blood will be either collected at the clinic of the ordering physician, or at an independent blood collection clinic.
- The DNA test kit can be sent by either of the clinics. Sending through an independent blood collection clinic might require extra fee.
- The DNA test kit is received by the test service provider. DNA is isolated from the biological sample, checked for quality and sequenced. The DNA code is analyzed for medical interpretation and a report is generated. The ordering physician can then have access to a clinical interpretation of the DNA code.
- The report is provided to the ordering physician for medical management consideration. The client/patient can only obtain the results from the ordering physician.
- Pathogenic results will require interpretation oversight by a genetic counsellor prior to medical action.
- The client/patient can choose either public or private genetic counselling access.
- The ordering physician determines medical management of the client/patient.
Purchase of the test can be refunded within 30-days of issued invoice date minus $50 processing fee to cover the costs associated with testing kit (even if the kit was not used by the customer). A refund is not available once the sample has been obtained by the laboratory and DNA testing has commenced.
138-8627 91 St NW, Edmonton AB
162-4005 Clover Bar Rd, Sherwood Park AB
7609 109 St NW, Edmonton AB
Please contact us if your clinic is interested in providing access to DNA testing.