2/25/2024 0 Comments Molecular diagnostics industryMoreover, this regulatory loophole establishes a far-from-level playing field for test manufacturers, as some widely used tests that have been reviewed and approved by Health Canada, such as Prosigna’s NanoString and Myriad’s EndoPredict prognostic tests for early-stage breast cancer, compete on the Canadian market with tests that have bypassed such review, like Oncotype Dx. But growing commercial interest in molecular diagnostics calls this approach into question. In the past, such tests were developed in specialized hospital laboratories they were not regulated as medical devices and were distributed to patients as a health service. However, manufacturers can avoid this regulatory approval process by using the laboratory-developed test loophole. They are subject to premarket review by Health Canada to evaluate evidence of their safety and efficacy. But these 3 tests were neither evaluated nor approved by Health Canada.ĭiagnostics developed as “test kits” and sold to laboratories, hospitals and clinics are considered to be in vitro diagnostics devices under Medical Devices Regulation in accordance with the federal Food and Drugs Act. Oncotype Dx - which offers women with early-stage invasive breast cancer information about their likely response to chemotherapy and the chance of recurring cancer - is reimbursed in BC, Alberta, Saskatchewan, Ontario, Quebec and Newfoundland. 3 In Canada, many molecular diagnostics are covered by provincial health plans: for example, Harmony and Panorama, noninvasive prenatal tests that screen for common fetal trisomies, are covered for high-risk pregnancies in Ontario, British Columbia and the Yukon. ![]() The global molecular diagnostics market was estimated to be worth US$7.3 billion in 2017. Molecular diagnostics increasingly play a pivotal role in control of infectious disease, diagnosis of hereditary diseases and aspects of oncology. In the interests of the nation’s health, it should. Regulators in Australia, the United States and Europe have made efforts to close this “gaping regulatory loophole,” 2 but Health Canada has not indicated that it plans to do the same. Absent regulation as medical devices, the only controls on test performance are laboratory regulation and accreditation, which are heterogeneous and sometimes flawed and do not necessarily include assessment of test validity, safety and efficacy. Such tests are not subject to Canada’s statutory regulation of medical devices for safety and efficacy, but they are widely used in Canada’s health care system. The recent expansion of the molecular diagnostics industry has revealed weaknesses in the regulatory system for all laboratory-developed tests. These devices are diagnostic tests produced by a company in its own clinical laboratories and marketed as commercial services to health care providers who send samples to those laboratories for analysis “in house.” Some laboratory-developed tests may also be developed by public clinical laboratories and offered to local clients. ![]() 1 Yet an important subset of medical devices remains outside the purview of this regulatory overhaul: laboratory-developed tests. Health Canada can show leadership in the regulation of laboratory-developed tests, by building on the efforts of other jurisdictions, just as it has led the way in drug and device data transparency.Īn international exposé of flawed regulations for medical implants prompted Canada’s health minister to announce sweeping changes to the regulation of medical devices.
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