MedMira Inc. has launched a clinical trial to evaluate its Multiplo TP/HIV rapid test for self-testing use in Canada, marking a significant step toward addressing the country's escalating HIV and syphilis epidemics. The first participants have been enrolled at the Cool Aid Community Health Centre in Victoria, British Columbia, and at Women's Health In Women's Hands Community Health Clinic in Toronto.
The trial, funded by the Canadian Institutes of Health Research (CIHR) and led by REACH Nexus at the MAP Centre for Urban Health Solutions at St. Michael's Hospital, is designed to support a new label claim application for self-testing. This development comes as Canada faces alarming increases in sexually transmitted infections, with new HIV diagnoses surging by over 35% from 2022 to 2023.
Regulatory Pathway Accelerated
MedMira received confirmation from Health Canada to bypass the typical non-professional use step and proceed directly with the self-testing application. This regulatory pathway typically requires obtaining approval for professional or non-professional use before pursuing a self-testing label claim.
"Following further discussions with Health Canada and the submission of previously collected clinical trial data, MedMira received confirmation to bypass the non-professional use step and proceed directly with the self-testing application," according to the company's announcement.
Hermes Chan, CEO of MedMira, emphasized the significance of this development: "This is a critical next step in making our Multiplo TP/HIV test available for self-testing in Canada. We're committed to providing a fast, accurate, and easy-to-use self-test that can deliver immediate results, helping people to know their status in the privacy of their homes and get connected to care."
Addressing Public Health Crisis
The clinical trial addresses urgent public health needs highlighted by recent data from the Public Health Agency of Canada. New HIV diagnoses in Canada surged by over 35% from 2022 to 2023, with Manitoba experiencing a spike of more than 40%. Saskatchewan reported 19.4 new HIV diagnoses per 100,000 people, more than triple the national average.
Syphilis cases have shown an equally concerning trend, nearly doubling from 6,371 cases in 2018 to 12,135 cases in 2023. Congenital syphilis cases have increased from 17 cases in 2018 to 53 cases in 2023, representing a 220% increase.
Dr. Sean B. Rourke, director of REACH Nexus and scientist at MAP, explained the strategic focus: "We're focusing all our efforts on the self-test because we know it will have the broadest reach of people who critically need it and the greatest public health impact on reducing new cases. It also puts the power directly in people's hands-giving them privacy, control, and the ability to act on their health when and where it works for them."
Test Technology and Implementation
The Multiplo TP/HIV rapid self-test provides immediate results from a simple finger-prick blood sample, testing for both HIV and syphilis simultaneously. A positive result can then be confirmed through laboratory testing, enabling people to quickly access culturally safe treatment and care.
Clinical trial implementation is expanding across multiple provinces, with additional sites launching in the coming weeks in Ontario and Nova Scotia. The trial partners with trusted community organizations including the Hassle Free Clinic in Toronto and the Halifax Sexual Health Clinic.
Chan positioned the self-test as "the most direct and effective path to having an immediate impact on the HIV and Syphilis epidemics," emphasizing the test's potential to reach individuals who may not otherwise access traditional testing services.
The trial represents a collaborative effort between MedMira, REACH Nexus, and community health organizations to address critical gaps in sexually transmitted infection testing and prevention across Canada.
