Health Canada approves MedMira’s Multiplo Rapid TP/HIV Test for Syphilis and HIV

MedMira Inc. (MedMira), a leading developer and manufacturer of Rapid Vertical Flow diagnostics, announced that on December 24, 2024, it has received the approval from Health Canada for its Multiplo Rapid TP/HIV Test (Multiplo TP/HIV) to be rolled out across Canada, a critical point-of-care tool to address the health crises with HIV and syphilis in Canada. The single Reveal TP (Syphilis) approval will follow soon after this more complex approval.

The Multiplo TP/HIV rapid test allows healthcare professional to accurately detect both HIV-1/2 and syphilis antibodies with one sample using a simple finger prick that delivers results immediately. This easy-to-use and high-quality test can be used in any setting and does not need any special storage conditions. Making it the perfect solution for use in hospitals, doctor’s offices and other settings and provides another important option in the Canadian market to help people know their status and get connected to treatment and care.

“Our Multiplo TP/HIV device is the fastest testing solutions for HIV-1/2 and Syphilis and has been used in various settings and markets (such as in Europe, Colombia etc) for years. The Health Canada Medical Device License for professional-use will immediately address critical gaps in healthcare settings at a fraction of the costs of conventional testing systems,” said Hermes Chan, CEO of MedMira, a world leader in developing rapid diagnostics and technologies. “Together with REACH Nexus we aim to supply urban and remote communities across Canada, and with it provide access to a critical needed screening tool. This test will have a significant impact on the already stretched and overburdened health care system by providing a fast and cost-efficient screening method.”

Health Canada’s licensure of the device is based on the results of a landmark clinical study in Alberta, co-led by Dr Sean B. Rourke, director of REACH Nexus and a scientist with the MAP Centre for Urban Health Solutions at St. Michael’s Hospital (Unity Health Toronto) and Dr Ameeta Singh at the University of Alberta.

“We urgently need more rapid testing options approved in Canada to reach the undiagnosed with HIV, syphilis and other blood-borne infections and sexually transmitted infections (STBBIs),” said Dr Rourke, the director of REACH Nexus at MAP. “We are very excited about this ongoing partnership with MedMira and the critical implementation science work that went into getting this device approved and into the hands of healthcare professionals.”

Health Canada’s approval of the Multiplo TP/HIV rapid test couldn’t come at a more urgent time. The latest data from the Public Health Agency of Canada, shows that new HIV diagnoses soared more than 35% from 2022 to 2023, with rates in Manitoba rising by more than 40%. In Saskatchewan, the rate of HIV was 19.4 per 100,000 people, more than three times the national rate. In 2022, there were 13,953 reported syphilis cases, with rates increasing by 109% compared to 2018, and with congenital syphilis cases seeing a 7% increase from 2021 and a 599% increase from 2018(1). With the rising cases, particularly in underserved and remote communities, the Multiplo TP/HIV provides an essential testing device to help reach the undiagnosed living with HIV and/or syphilis.

“These tests are essential amid the rising number of STBBIs and will have real-life impacts,” said Dr. Rourke. “Not everyone has access to the testing they need for STBBIs because of health inequities, stigma and various forms of discrimination. MedMira’s rapid test is a crucial tool in Canada - so everyone can have access to the testing they need.”

As part of Health Canada's review and authorization process, Dr Rourke’s team of researchers sourced funding and conducted the landmark study working closely with healthcare providers, provincial health ministry and laboratory agencies, community stakeholders, and people with lived experience.

The study, conducted from 2020-2022, included over 1,500 participants from clinical settings in Edmonton and northern Alberta. The study found the Multiplo TP/HIV test to be 100 per cent accurate in identifying HIV infection, and more than 98 per cent accurate in detecting syphilis.

“Having more HIV rapid tests increases our chances of reaching people in Canada who have HIV and don’t know it, and a very significant and increasing number of infectious and congenital syphilis cases” said Dr. Rourke. “This rapid, accessible test helps breakdown barriers that some people face so they can get tested so they know their status. It helps move closer to ending the HIV and syphilis epidemics in Canada.”

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. REACH Nexus is part of MAP Centre for Urban Health Solutions at St. Michael's Hospital, Unity Health Toronto, and is funded by the Canadian Institutes of Health Research.

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.

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