American Marconi Wireless News - MedMira Announces Launch of Clinical Trial for Its Multiplo(R) TP/HIV 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, 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. We believe this is the most direct and effective path to having an immediate impact on the HIV and Syphilis epidemics."

Recent data from the Public Health Agency of Canada show alarming increases in both HIV and syphilis:

• New HIV diagnoses in Canada surged by over 35% from 2022 to 2023, with a >40% spike in Manitoba.

• Saskatchewan reported 19.4 new HIV diagnoses per 100,000 people, more than triple the national average.

• Syphilis cases nearly double from 2018 to 2023 from 6,371 cases to 12,135 cases.

• Congenital syphilis cases have also increased, rising from 17 cases in 2018 to 53 cases in 2023 - a 220% increase since 2018.

The Multiplo® TP/HIV rapid self-test provides immediate results from a simple finger-prick blood sample. A positive result can then be confirmed through lab testing, enabling people to quickly access culturally safe treatment and care.

Clinical trial implementation is now underway across multiple provinces, with the first participants enrolled in Victoria, B.C. and Toronto, Ont. Additional sites will launch in the coming weeks in Ontario and Nova Scotia, in partnership with trusted community organizations including the Hassle Free Clinic in Toronto, and the Halifax Sexual Health Clinic.

About REACH Nexus at St. Michael's Hospital's MAP Centre for Urban Health Solutions

REACH Nexus is an ambitious national research group working on how to address HIV, Hepatitis C, and other sexually transmitted and blood-borne infections (STBBIs) in Canada. Their focus is on reaching the undiagnosed, implementing and scaling up new testing options, strengthening connections to care, improving access to options for prevention (PrEP and PEP) and ending stigma. We work in collaboration and partnership with people living with HIV; community-based organizations; front-line service providers; healthcare providers and decision makers; public health agencies; researchers; business leaders; industry partners, and federal, provincial and regional policymakers.Follow us on Twitter, Instagram and Facebook.

About MedMira

MedMira is a leading developer and manufacturer of Rapid Vertical Flow^® diagnostics. The Company's tests providehospitals, labs, clinics, and individuals with instant disease diagnosis, such as HIV, Syphilis, Hepatitis, and SARS-CoV-2, in just three easy steps. The Company's tests are sold globally under the REVEAL^®, REVEALCOVID-19^®, Multiplo^®and Miriad^® brands. Based on its patented Rapid Vertical Flow^® Technology, MedMira's rapid HIV test is the only one inthe world to achieve regulatory approvals in Canada, the United States, China and the European Union. MedMira's corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada. For more information visit medmira.com. Follow us on Twitterand LinkedIn.

This news release contains forward‐looking statements, which involve risk and uncertainties and reflect the Company's current expectation regarding future events, including statements regarding possible regulatory approval, product launch, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

MedMira Contact

Markus Meile
Chief Financial Officer
MedMira Inc.
[email protected]
Phone 902-450-1588

REACH Nexus Contact

Andrew Russell
Senior Communications Specialist
REACH Nexus - MAP Centre for Urban Health Solutions
[email protected]
Phone 647-237-2912

SOURCE: MedMira, Inc.

View the original press release on ACCESS Newswire

P.Santos--AMWN