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MedMira Announces Launch of Clinical Trial for Its Multiplo(R) TP/HIV Self-Test in Canada
HALIFAX, NS / ACCESS Newswire / July 7, 2025 / MedMira Inc. (MedMira) (TSXV: MIR) and REACH Ne...
About this update from Medmira Inc.
[{"type":"text","content":"MedMira Announces Launch of Clinical Trial for Its Multiplo(R) TP/HIV Self-Test in CanadaHALIFAX, NS / ACCESS Newswire / July 7, 2025 / MedMira Inc. (MedMira) (TSXV: MIR) and REACH Nexus are excited to announce a clinical trial has officially started earlier than anticipated to evaluate MedMira's Multiplo® TP/HIV rapid test for use as a self-test in Canada.MedMira has been able to move forward with this label claim and avoid additional testing requirements (e.g., by non-health care professions) with agreement from Health Canada.The first participants have now been successfully enrolled at the Cool Aid Community Health Centrein Victoria, British Columbia and at Women's Health In Women's Hands Community Health Clinic in Toronto, marking a critical step in bringing this dual HIV and syphilis self-test to communities that need it most.This 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 (Unity Health Toronto)-is designed to support a new label claim application for self-testing.\"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,\" said Dr. Sean B. Rourke, director of REACH Nexus and scientist at MAP. \"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.\"Typically, regulatory pathways require obtaining approval for professional or non-professional use before a self-testing label claim can be pursued. Professional use refers to the test being administered by health care practitioners, and non-professional use refers to testing performed by lay users under supervision, whereas self-testing allows individuals themselves to perform the test on their own at home.However, 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.\"This is a critical next step in making our Multiplo® TP/HIV test available for self-testing in Canada,\" said Hermes Chan, CEO of MedMira. \"We're committed to providing a fast, ...