Key Takeaways
- MedMira receives Health Canada authorization to trial self-administered and non-professional Multiplo® TP/HIV tests.
- The tests aim to improve accessibility for syphilis and HIV diagnostics in Canada, especially in underserved regions.
- Clinical trials, led by REACH Nexus, will engage 1,700 participants in three provinces.
MedMira Inc. announced Health Canada’s approval for Investigational Testing Authorizations (ITAs) to initiate clinical trials for its Multiplo® TP/HIV self-test and non-professional use test. These advancements aim to address Canada’s escalating rates of syphilis and HIV by providing individuals and communities with rapid, easy-to-use diagnostic options.
The new applications build on the success of the already approved Multiplo® TP/HIV test, introducing tools for self-testing and administration by non-professionals, such as peers or community health workers. These innovations are designed to empower users with immediate results—detecting both syphilis and HIV antibodies using a simple finger-prick blood sample—delivered in minutes.
“These ITAs represent a crucial step toward broadening access to life-saving diagnostics,” said Hermes Chan, CEO of MedMira. “With self-tests and non-professional administration, we’re removing barriers to testing, especially in underserved communities, and ensuring more Canadians can take control of their health.”
Addressing Canada’s Rising Infection Rates
Recent data from the Public Health Agency of Canada underscores the urgency of MedMira’s innovations. HIV diagnoses rose by over 35% between 2022 and 2023, with Manitoba and Saskatchewan experiencing sharp increases. Saskatchewan’s HIV rate of 19.4 cases per 100,000 people is more than three times the national average.
Syphilis rates have also surged, with 13,953 cases reported in 2022, representing a 109% increase since 2018. Congenital syphilis cases, a particularly alarming trend, have climbed nearly 600% over the same period, contributing to 15 stillbirths in 2022.
Amid these alarming statistics, MedMira’s Multiplo® TP/HIV rapid tests provide a vital solution. By enabling self-testing and community-based use, these tools can reach populations that often avoid traditional healthcare settings due to stigma or access barriers. Positive results from these tests can be followed up with lab confirmation and prompt linkage to treatment.
Collaborative Efforts to Improve Public Health
The upcoming trials, funded by the Canadian Institutes of Health Research (CIHR) and led by REACH Nexus at St. Michael’s Hospital, will include 1,700 participants across Ontario, Manitoba, and British Columbia. Partnering with organizations like Women’s Health in Women’s Hands (Toronto) and Nine Circles Community Health Centre (Winnipeg), the trials aim to evaluate the efficacy and impact of these diagnostic tools.
“HIV self-testing could connect more than 8,000 undiagnosed Canadians to care,” said Dr. Sean B. Rourke, director of REACH Nexus. “For syphilis, while exact undiagnosed figures remain unclear, the need for intervention is immediate. MedMira’s accessible tests are key to bridging these gaps and addressing health inequities.” The trials are part of a broader “test, treat, and connect” initiative, emphasizing the role of community partnerships in delivering culturally sensitive care.
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