Regulatory oversight of genetic testing in Canada: Health Canada perspective

Regulatory Oversight of Genetic Testing in Canada Health Canada Perspective Patrice Sarrazin, PhD Senior Scientific Evaluator In Vitro Diagnostic Devices Medical Devices Bureau Therapeutic Product Directorate Health Canada patrice.sarrazin@hc-sc.gc.ca

Outline 1. Definition 2. Food and Drugs Act and Medical Devices Regulations 3. Classificiation of Medical Devices 4. Investigational Testing 5. Application for a Medical Device Licence 6. LDTs and DTC Genetic Testing: Where do they fit?

Definitions Devices (Food and Drugs Act) “device” means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, (b) restoring, correcting or modifying a body function or the body structure of human beings or animals, (c) the diagnosis of pregnancy in human beings or animals, or (d) the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring,

Definitions In Vitro Diagnostic Device (Medical Devices Regulations) “in vitro diagnostic device” or “IVDD” means a medical device that is intended to be used in vitro for the examination of specimens taken from the body. Genetic Testing (Medical Devices Regulations) “genetic testing” means the analysis of DNA, RNA or chromosomes for purposes such as the prediction of disease or vertical transmission risks, or monitoring, diagnosis or prognosis.

Definitions Manufacturer (Medical Devices Regulations) “manufacturer” means a person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf.

Food and Drugs Act & Medical Devices Regulations Health Canada regulates the manufacture and sale of medical devices in Canada. The Food and Drugs Act and Medical Devices Regulations are the tools used to ensure that safe and effective devices are available. Manufacturers of devices apply to Health Canada to receive either: 1. Medical Device Licence 2. Investigational Testing Authorization 3. Special Access Program Request Food and Drug Act = http://laws.justice.gc.ca/eng/C.R.C.-c.870/index.html Medical Devices Regulations = http://laws.justice.gc.ca/PDF/Regulation/S/SOR-98-282.pdf

Risk Based Classification System for Medical Devices Part 1 Medical Devices other than IVDD Schedule 1 Classification Rules for Medical Devices Part 2 In Vitro Diagnostic Devices Based on public health and individual risk and IVDD use outcome Class I (Thermometer) Minimal risk. Risk level Class II (Culture media) for IVDD Low public health risk or moderate individual risk. As per rule 4 of the Risk Based Classification Class III (MRSA detection) System, IVDDs intended to be used for genetic Moderate public health risk or high individual risk. testing are classified as Class III Class IV (HIV Donor Screening) Present a high public health risk.

Regulatory Pathways Investigational Testing Authorization Medical Device Licence Special Access Program

Investigational Testing Requirements A manufacturer or importer of a Class II, III or IV medical device may sell the device to a qualified investigator for the purpose of conducting investigational testing if the manufacturer or importer holds an authorization issued under the Medical Devices Regulations and possesses records that contain all the information and documents required by the regulations. a) Manufacturer information b) Device name & identifier c) Device description & materials d) Intended Use e) Marketing history f) Risk Assessment g) Investigators Information h) Institutions (written approval) i) Study protocol j) Labelling k) Investigator’s Agreement

Pharmacogenomics Trials At the clinical trial stage, PGx testing used for diagnostic purposes or patient management can be achieved in two ways: (i) Use of a PGx test that is licenced for sale in Canada; (ii) Use of a PGx test that is authorized for investigational testing PGx Trials Companion Diagnostics Drugs / Biologics Medical Devices Bureau Office of Clinical Trial, TPD or BGTD Test licenced in Application for Application for Clinical Trial Autorization Canada Investigational Testing Autorization 30 day default period 30 days Investigational No Objection Letter (NOL) Testing Autorisation Letter Guidance Document: Submission of Pharmacogenomic Information

Application for a New Medical Device Licence Requirements for Class 3 Device Licences • Background Information Identification • Summary of S & E Studies ISO 13485 information Quality System ! List of Standards ! Method of Sterilization ! Summary of Studies Certificate from ! Bibliography CMDCAS • Labelling “recognized” auditing • Near Patient IVDD organization

Supporting the Safety and Effectiveness Basic parameters to be controlled for when validating a commercially available kit • Analytical Specificity • Limit of detection (LOD) • Linearity range • Lower Limit of Quantification (LLOQ) • Upper Limit of Quantification (ULOQ) • Precision (intra-run, inter-run, inter-lab, inter-lot) • Accuracy • Recovery • Matrix interference • Open and On-board Stability • Shelf Life Stability (-20°C, -80°C) • Freeze/Thaw Stability • Working Standard Solutions Stability • Reference ranges This list is not comprehensive and may vary.

LDTs & DTC Genetic Testing Laboratory-developed tests and Direct-to-Customer genetic testing fall outside the scope of the Food and Drug Act and the Medical Devices Regulations. Laboratory-Developed Tests = Test not manufactured for sale DTC Genetic Testing = Testing services fall outside the scope of the regs

Direct-to-Customer Genetic Testing Online Order Reception of the sample collection kit Specimen collection Baby Gender Test Kit •Pregnancy test kit •Alcohol pad •Blood collection device (lancet) •Collection card •Return envelop Results provided to the customer Laboratory testing Shipping

Regulatory oversight of DTC Genetic Testing Testing services are not regulated under the Food and Drug Act What about the sample collection kit? • Pregnancy test kit = Class II Medical Devices • Desinfectant pad • Blood collection device (lancet) = Class II Medical Devices • Collection card • Return envelop Consult the Medical Device Active Licence Listing (MDALL) www.mdall.ca

Public Notices It’s Your Health Articles Joint publication produced by Health Canada and the Public Health Agency of Canada that provides information you can trust on a wide range of health and safety issues. •Buying drugs over the internet •Medical Devices Test Kits for Home-Use www.hc-sc.gc.ca

Regulatory Oversight of In-House Genetic Tests Genetic Tests developed in-house !"#$%"&'()*+%',"-."/'+*%0"1+2+,+ Clinical Laboratories under provincial jurisdiction (oversight varies from province to province) ! Accreditation Programs based on ISO 15189: Medical Laboratories Particular requirements for quality and competence ! Provisions for in-house procedures: 5.5.1 … If in-house procedures are used, they shall be appropriately validated for their intended use and fully documented. 5.5.2 The laboratory shall use only validated procedures for confirming that the examination procedures are suitable for the intended use.

Personalized Medicine Working Group Health Portfolio working group on personalized medicine – mandated to conduct comprehensive policy analysis on personalized medicine. Need to ensure that there is a coordinated approach that protects and promotes the health of Canadians, while maximizing the advantages offered by personalised medicine. Activities that Health Canada has been involved in so far include: Pharmacogenomics Guidance document, participation in ICH E-15 and E-16 initiatives, and regulatory modernization.

Question ? Therapeutic Products Directorate Medical Devices Bureau Licensing Services Division Room 1605, Statistics Canada Main Building, 150 Tunney’s Pasture Driveway Ottawa, Ontario K1A 0K9 Address Locator: 0301H1 Phone: 613-957-7285 Fax: 613-941-4726 E-mail: mgr-lsd_mdbtpd@hc-sc.gc.ca

Regulatory oversight of genetic testing in Canada: Health Canada perspective

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