Health Canada approves MedMira’s Reveal® Rapid TP Test - Urgent New Tool In The Battle Against Syphilis

Original from: MedMira

MedMira Inc. (MedMira) (TSXV: MIR) announced today that it has received approval from Health Canada for its Reveal® TP (Syphilis) Antibody Test (Reveal® TP) – the fastest standalone screening device for syphilis in Canada.

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.

Source: Health Canada approves MedMira’s Reveal® Rapid TP Test - Urgent New Tool In The Battle Against Syphilis