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- RE: Response from the CSA Technical Committee Z252.11 Lab-developed Tests
The Canadian Standards Association (operating as “CSA Group”) is a private, not-for-profit company that publishes voluntary standards, and related documents, through a consensus-based standards development process approved by the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve consensus.
The first edition of CSA Z316.8:18 Requirements for the design, development, and validation of laboratory-developed tests used for the screening, diagnosis, and management of clinical conditions assists in achieving harmonization of the management of laboratory-developed tests (LDTs). The standard provides guidance to laboratories and assists accreditation bodies in the establishment of a standardized validation process.Members of CSA Technical Committees (TCs) and Subcommittees (TSCs) provide technical expertise in the content development of standards; they do not act on behalf of the association or organization where they are employed. Financial support to develop the standard was provided in part from the governments of the provinces and territories, as administered by CADTH, CSMLS, Alere ULC, Siemens and Roche, and developed in accordance with CSA Group’s accredited process. The standard was developed by voluntary members of the TSC for LDTs, and approved by the TC. Members represent their respective stakeholder groups and are chosen based on their experience relevant to such stakeholder group....
Show MoreCompeting Interests: None declared.References
- Kelly Holloway, Fiona A. Miller, François Rousseau, et al. Health Canada needs to act on laboratory-developed diagnostics. CMAJ 2019;191:E1067-E1069.
- RE: Responses to Health Canada needs to act on laboratory-developed diagnostics
We appreciate the responses to our article entitled, “Health Canada needs to act on laboratory-developed diagnostics.” Michele D’Elia from Roche Diagnostics offers an update by indicating that the company’s NIPT test was approved by Health Canada as our article was under review. Roche volunteered to submit an application for their test after it had been on the Canadian market for several years, demonstrating our point that Health Canada does not require pre-market approval for laboratory-developed tests. Further, we agree that the voluntary standard Roche helped to develop through the Standards Council of Canada could be a useful first step to set minimal requirements for these tests. We reiterate that this voluntary standard does not require any manufacturer to submit their test for an external evaluation for safety and efficacy.
We also acknowledge the position advanced by Donna M. Berry and colleagues, that in some cases it may be necessary to balance the need for regulatory guidelines and oversight with the importance of access to novel tests for patients that have no other options. Our paper touches on the EU’s approach to regulation, where a health institution exemption would require reduced but enhanced oversight for tests that are used within individual hospital laboratories. Health Canada should look to this type of international leadership on medical devices to improve the regulation of laboratory-developed diagnostics in Canada.
Competing Interests: None declared. - RE: Health Canada needs to act on laboratory-developed diagnostics
We wish to acknowledge the work of Holloway et al. for highlighting the current regulation gap that exists in Canada with laboratory-developed tests and identifying the role of regulators such as Health Canada in ensuring that licensed tests undergo a rigorous review process to evaluate their safety and efficacy. The article mentions that the non-invasive Harmony prenatal test was neither evaluated nor approved by Health Canada. This is no longer the case as Harmony became, on September 4th 2019, the first non-invasive prenatal test (NIPT) to meet the Health Canada Medical Devices Bureau's requirements of safety, effectiveness and quality1. The authors also identify a voluntary standard introduced in April 2018 by Standards Council of Canada (Z316.8-18 on Requirements for the Design, Development and Validation of Laboratory-Developed Tests)2. While the standard, as a stand-alone document does not recognize the safety and efficacy of a test, its application by a laboratory-accreditation organization such as Institute for Quality Management in Healthcare (IQMH)3 or its inclusion in Institut National d'Excellence en Santé et Services Sociaux (INESSS) review process4 may serve as a first step to set the minimal requirements for such tests.
1. https://health-products.canada.ca/mdall-limh/information.do?lang=eng&lic...
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2....Competing Interests: Michele D’Elia is an employee of Roche Diagnostics who commercializes the Harmony Prenatal test. - RE: Health Canada needs to act on laboratory-developed diagnostics
We read with interest the CMAJ commentary “Health Canada needs to act on laboratory-developed diagnostics” and agree enthusiastically with the authors’ assertation that the Canadian regulatory system must be updated to address issues arising as molecular diagnostic technologies are developed and adopted. However, we wish to highlight another class of tests, which need to be considered, especially in precision health and the context of rare diseases, a common issue in children. These are tests performed in specialized research laboratories which due to the complexity of specific assays and/or the low number of cases, cannot currently be feasibly implemented in clinical laboratories or developed as a laboratory developed test (LDT). As an example, RNA sequencing can detect fusions between two unrelated genes in a tumour. The detection of certain rare fusion proteins may support the use of molecularly targeted drugs in otherwise chemotherapy-resistant deadly tumours. Not all genetic findings can be validated due to technique, especially when variants are rare or unique to an individual. Moreover, retesting and validation adds a considerable financial burden. Under the current Ontario regulations (1) this type of research testing would be unavailable to patients as the results must be validated in an accredited clinical laboratory before use for diagnosis or treatment. While we recognize the need for regulatory guidelines and oversight, we also need to acknowledge the import...
Show MoreCompeting Interests: None declared.