Star Metro - Health Canada Approves MedMira's Reveal(R) Rapid TP Test - Urgent New Tool In The Battle Against Syphilis

A vital point-of-care tool for healthcare professionals, Reveal® TP is a crucial advancement in expanding access to syphilis testing across Canada-particularly in the Prairie provinces, where rates of infectious and congenital syphilis are surging.

The test detects syphilis antibodies from a single finger-prick blood sample, delivering results immediately that do not fade away. It is the fastest Syphilis test licensed in Canada using MedMira's proprietary Rapid Vertical Flow (RVF) Technology.

Health Canada's approval of the device is based on the results of multiple clinical trials, testing a total of 1,760 individuals, in Alberta and Saskatchewan and sponsored by Dr. Sean B. Rourke, Director of REACH Nexus and a scientist at the MAP Centre for Urban Health Solutions at St. Michael's Hospital (Unity Health Toronto) with funding from the Canadian Institutes of Health Research (CIHR). One of these studies, the "test, treat and connect" study, was led by Dr. Stuart Skinner of the University of Saskatchewan and Nikki Williamson of the Wellness Wheel Medical Clinic in Regina-a non-profit organization providing culturally responsive HIV and sexually transmitted and blood-borne infection (STBBI) care in First Nations communities.

This precise, easy-to-use test can be deployed in a range of healthcare settings, from hospitals and doctors' offices to community health clinics and non-profit community agencies. It offers an important new option in Canada for identifying syphilis cases and connecting individuals to timely treatment and care.

"We are proud to expand Canada's diagnostic toolbox with a solution that aligns with the need for speed, reliability, and scalability," said Hermes Chan, CEO of MedMira. "This approval reflects our commitment to developing technologies that address urgent public health challenges while improving access to care."

Canada has seen a dramatic rise in syphilis cases in recent years. Syphilis is a sexually transmitted infection caused by the bacterium Treponema pallidum. It can lead to painless sores or, in more advanced cases, serious organ damage. Congenital syphilis, which occurs when an untreated or inadequately treated pregnant person passes the infection to their baby, can result in stillbirth or other serious outcomes.

According to the latest data from the Public Health Agency of Canada, syphilis cases nearly doubled from 6,371 in 2018 to 12,135 in 2023. Congenital syphilis has also risen sharply, from 17 in 2018 to 53 in 2023- or a 220% increase.

"Infectious syphilis is a public health emergency in Canada, sweeping across communities-especially in Alberta, Saskatchewan, and Manitoba," said Dr. Sean B. Rourke, Director of REACH and MAP scientist at St. Michael's Hospital. "Having another rapid point-of-care syphilis test is critical to help people get tested quickly and connected to culturally appropriate care. The more individuals we diagnose and treat, the faster we can help end this tragic health crisis."

With CIHR funding, Dr. Rourke and his team at REACH Nexus conducted a study to evaluate MedMira's test across 20 sites in Saskatchewan. These included First Nations communities, remote regions, community health locations, and a federal penitentiary.

"Having this standalone syphilis rapid test is a significant step toward engaging Indigenous communities-particularly those in rural and remote areas-with more accessible STBBI testing options," said Williamson, a registered nurse. "This is vital to developing culturally informed and self-determined testing strategies that promote prevention, early detection, and connection to care, all with the goal of eradicating syphilis."

Reveal® TP joins MedMira's expanding portfolio of approved rapid tests, including the Multiplo® Rapid TP/HIV Antibody Test and Reveal® G4 Rapid HIV-1/2 Antibody Test, both licensed by Health Canada in December 2024 and January 2025. All MedMira tests are developed and manufactured in Halifax, Nova Scotia.

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 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 provide hospitals, 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 in the 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 Twitter and 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 416-268-7642

SOURCE: MedMira, Inc.

View the original press release on ACCESS Newswire

A.Harris--SMC