Health Canada's Approval: MedMira's Game-Changing Rapid HIV/Syphilis Test

MedMira Inc. (TSXV:MIR) announced the approval of its Multiplo® Rapid TP/HIV Test by Health Canada, a significant development in addressing the escalating public health challenges posed by HIV and syphilis in Canada. A separate approval for the Reveal® TP (Syphilis) test is also anticipated soon.

A Simple and Effective Diagnostic Solution

The Multiplo® TP/HIV test enables healthcare providers to detect both HIV-1/2 and syphilis antibodies from a single finger-prick sample, providing immediate results. This portable and easy-to-use diagnostic tool requires no special storage conditions, making it ideal for use in hospitals, clinics, and remote healthcare settings.

“Our Multiplo® TP/HIV device is the fastest solution for HIV-1/2 and syphilis testing,” said Hermes Chan, CEO of MedMira. “This approval equips Canada with a cost-effective screening tool that addresses critical healthcare gaps, particularly in underserved and remote communities. The test’s speed and reliability will help reduce the burden on Canada’s overextended healthcare system.”

Addressing an Urgent Need

The approval comes amid rising infection rates:

• HIV: New diagnoses surged by over 35% between 2022 and 2023, with Manitoba reporting a 40% increase and Saskatchewan showing an HIV rate of 19.4 per 100,000 people, over three times the national average.
• Syphilis: Cases climbed to 13,953 in 2022, a 109% increase since 2018. Congenital syphilis cases also spiked, with a staggering 599% increase since 2018.

The Multiplo® TP/HIV test is expected to be instrumental in reaching undiagnosed individuals, particularly in communities facing health inequities, stigma, and systemic barriers to care.

Landmark Study and Collaborative Efforts

The approval was based on a clinical study conducted in Alberta, led by Dr. Sean B. Rourke, director of REACH Nexus, and Dr. Ameeta Singh of the University of Alberta. The study involved over 1,500 participants and demonstrated the test’s exceptional accuracy—100% for HIV detection and over 98% for syphilis.

“This rapid, accessible test helps break down barriers to testing, enabling people to know their status and take steps toward care,” said Dr. Rourke. “It’s a critical tool in our efforts to end the HIV and syphilis epidemics in Canada.”

Collaborative Impact and Future Goals

In partnership with REACH Nexus, MedMira aims to roll out the test across Canada, prioritizing urban and remote communities. “Together, we’re providing access to an urgently needed screening tool,” Chan emphasized.

As Canada contends with increasing rates of sexually transmitted and blood-borne infections (STBBIs), the Multiplo® TP/HIV test offers a vital solution for more effective and equitable healthcare delivery. By enabling faster diagnosis and connection to care, this innovation brings Canada closer to controlling the HIV and syphilis crises.