Approve microclots test

AI summary

Petitioners ask the government to validate and approve the flow‑cytometry fibrinogen amyloid microclots test as a reference diagnostic and fund a pilot. The government responds that provinces, not Health Canada, regulate in‑house laboratory tests.

AI summaries describe petitioners’ requests and claims. Consult the official record for the full text.

Official petition

Petition to the Government of Canada We, the undersigned, residents and citizens of Canada, draw the attention of the House of Commons to the following: Whereas: Long COVID affects approximately 1.4 million Canadians, causing significant health and economic burdens (Statistics Canada, 2023); The Flow Cytometric Detection of Fibrinogen) Amyloid Microclots test, supported by global research (Turner et al., 2023; Nunes et al., 2024; Kell et al., 2024), identifies microclots linked to Long COVID symptoms, enabling targeted therapies; This test uses existing flow cytometry infrastructure, making it feasible for implementation at Canadian institutions like UBC and Vancouver General Hospital. Health Canada has not yet approved this test, delaying access to critical diagnostics due to regulatory and validation barriers. Canadians deserve equitable access to innovative diagnostics to address Long COVID's impact. Therefore, your petitioners call upon the Government of Canada to: Prioritize the validation and approval of the Flow Cytometric Detection of Fibrinogen) Amyloid Microclots as a reference test; Consider the advisability of funding a national pilot program, led by institutions like UBC and Vancouver General Hospital, to generate real-world evidence for the test; and Implement regulatory reforms to streamline the approval process for laboratory-developed tests (LDTS), addressing unmet medical needs like Long COVID.

Government response

Response by the Minister of Health Signed by Maggie Chi The Government of Canada supported the development of a series of Canadian Guidelines for Post COVID-19 Condition (CAN-PCC) to help people make informed decisions about their health. Over 100 recommendations have been released and are available at canpcc.ca. The Post COVID-19 condition (long COVID) webpage provides additional information on long COVID that may be helpful, including: Information on preventing long COVID with vaccination; Information on preventing long COVID with personal protective measures; and Other preventative measures. The federal government also helped fund the creation of guidelines and tools for Post-COVID-19 Condition to support patients, caregivers and health professionals. These recommendations are available online. Regarding the approval of specific diagnostic tests, provinces and territories are responsible for the delivery and administration of health care services, including public and private laboratory-developed tests and testing services. As the tests and testing services fall under provincial jurisdiction, Health Canada does not regulate testing services or tests developed by public and private laboratories for their in-house use. Further questions on such regulations would need to be directed to the relevant provincial or territorial health authorities.