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Early Start for Crucial Health Study
MedMira Inc. (TSXV: MIR) and REACH Nexus have officially announced the early launch of a clinical trial to evaluate the Multiplo® TP/HIV rapid test for self-use in Canada. This dual test is designed to detect both HIV and syphilis, offering a private and accessible option for individuals who may not otherwise get tested.
Health Canada Accelerates Approval Pathway
Thanks to Health Canada’s support, MedMira was able to fast-track its efforts to introduce the self-test without having to complete the usual step of testing by non-professionals under supervision. This regulatory greenlight allows the company to move directly to self-testing approval, streamlining the process and reducing delays.
First Participants Enrolled
Initial participants have already been enrolled at two key community health centers: the Cool Aid Community Health Centre in Victoria, British Columbia, and the Women’s Health in Women’s Hands Community Health Clinic in Toronto. These clinics serve populations at higher risk and are expected to play a pivotal role in ensuring the test reaches communities with the greatest need.
Nationally Funded Study Backed by Top Institutions
The study is being conducted by REACH Nexus, part of the MAP Centre for Urban Health Solutions at St. Michael’s Hospital (Unity Health Toronto), and is funded by the Canadian Institutes of Health Research (CIHR). Its aim is to gather data that will support a formal application for the Multiplo® TP/HIV test as a licensed self-test in Canada.
Empowering Communities with Accessible Testing
Dr. Sean B. Rourke, Director of REACH Nexus and scientist at MAP, emphasized the importance of self-testing in combating infectious diseases: “We are putting all our efforts into self-testing because we know it reaches the people who need it most. It has the biggest impact on public health by helping reduce new infections. It also gives people control—privacy, autonomy, and the ability to take action on their health on their own terms.”
Shifting the Regulatory Landscape
Typically, regulatory processes require phased approvals—first for professional use (administered by healthcare providers), followed by supervised use by laypersons, before allowing full self-testing. However, based on previously submitted clinical data and ongoing dialogue with Health Canada, MedMira was able to skip the intermediate step, accelerating the path to self-test availability.
A Step Forward in HIV and Syphilis Prevention
MedMira CEO Hermes Chan highlighted the broader implications of this development: “This is a critical step in making our Multiplo® TP/HIV test available for self-testing in Canada. We are committed to providing a fast, accurate, and easy-to-use self-test that delivers results immediately. Our goal is to help people learn their status in the privacy of their own home and get connected to care. We believe this is the most effective and direct way to tackle the HIV and syphilis epidemics head-on.”
Looking Ahead
With clinical trials now underway and a fast-tracked regulatory path, MedMira and REACH Nexus are pushing forward to make self-testing a reality for Canadians. If successful, the Multiplo® TP/HIV self-test could become a vital tool in public health strategies aimed at curbing the spread of HIV and syphilis across the country.
