MedMira Inc. announced that it received, on December 24, 2024, approval from Health Canada for its Multiplo® TP/HIV rapid test (Multiplo® TP/HIV) which will be deployed across Canada, a state-of-the-art tool essential service to address the health crises linked to HIV and syphilis in Canada. Approval of Reveal® TP (syphilis) will follow shortly after this more complex approval. The Multiplo® TP/HIV rapid test allows healthcare professionals to accurately detect HIV-1/2 and syphilis antibodies from a single sample, with a simple finger prick that provides immediate results.
This easy-to-use, high-quality test can be used in any setting and does not require special storage conditions. This makes it the ideal solution for hospitals, doctor's offices and other facilities and provides another important option in the Canadian market to help people know their status and connect with treatment and care. Health Canada's approval of the device is based on the results of a landmark clinical study conducted in Alberta, led by Dr. Sean B. Rourke, director of REACH Nexus and scientist at the hospital's MAP Center for Urban Health Solutions St.
Michael's Hospital (Unity Health Toronto) and Dr. Ameeta Singh of the University of Alberta. Health Canada's approval of the Multiplo® TP/HIV rapid test could not have come at a more timely time. The latest data from the Public Health Agency of Canada shows new HIV diagnoses increased by more than 35% between 2022 and 2023, with rates increasing by more than 40% in Manitoba.
In Saskatchewan, the HIV rate was 19.4 per 100,000 people, more than three times the national rate. In 2022, 13,953 cases of syphilis were reported, with rates increasing 109% from 2018 and congenital syphilis cases increasing 7% from 2021 and 599% from 2018(1). Given the increasing number of cases, particularly in underserved and remote communities, the Multiplo® TP/HIV is a critical screening device to help reach undiagnosed people living with HIV and/or syphilis .
As part of Health Canada's review and authorization process, Dr. Rourke's team of researchers secured funding and conducted the landmark study in close collaboration with health care providers, provincial ministries of health and laboratory organizations, community stakeholders, and people with lived experience. The study, conducted between 2020 and 2022, included more than 1,500 participants from clinical settings in Edmonton and northern Alberta. The study found that the Multiplo® TP/HIV test was 100% accurate in identifying HIV infection and more than 98% accurate in detecting syphilis.
About REACH Nexus at the MAP Center for Urban Health Solutions: REACH Nexus is an ambitious national research group studying ways to combat HIV, hepatitis C and other sexually transmitted and blood-borne infections (STDs). in Canada. Its goal is to reach undiagnosed people, implement and scale new screening options, strengthen links to care, improve access to prevention options (PrEP and PEP) and end stigma. The company works collaboratively and in partnership with people living with HIV, community organizations, frontline service providers, healthcare providers and policymakers, public health agencies, researchers, leaders company, industrial partners and federal, provincial and regional policy makers.
REACH Nexus is part of the MAP Center for Urban Health Solutions at St. Michael's Hospital, Unity Health Toronto, and is funded by the Canadian Institutes of Health Research.
