Federal regulators have approved a new dual HIV-Syphilis rapid test, a critical point-of-care tool to address the public health crises of rising HIV/Syphilis rates in Canada, particularly in the Prairies.
Health Canada granted a medical device licence on Dec. 24, 2024 to Nova Scotia-based MedMira Inc. for its Multiplo® TP/HIV Rapid Test. The device allows healthcare professionals to detect both HIV-1/2 and syphilis antibodies using one blood sample from a single finger prick that delivers results immediately.
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 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 the critical implementation science work that went into getting this device approved and into the hands of healthcare professionals.”
The latest data from the Public Health Agency of Canada shows that new HIV diagnoses risen more than 35 per cent from 2022 to 2023, with rates in Manitoba rising by more than 40 per cent. In Saskatchewan, the rate of HIV was 19.4 per 100,000 people, more than three times the national rate.
Syphilis rates have also seen a significant rise in recent years. In 2022, there were 13,953 reported syphilis cases, with rates increasing by 109 per cent compared to 2018, and with congenital syphilis cases seeing a seven per cent increase from 2021 and a 599 per cent increase from 2018.
“Our Multiplo® TP/HIV device is the fastest testing solution for HIV-1/2 and Syphilis and provides an immediate result which does not fade. 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.
“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 tremendous impact on the already stretched and overburdened health care system by providing a fast and cost-efficient screening method.”
As part of Health Canada’s review and authorization process, Dr. Rourke’s team of researchers sourced funding and conducted the 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.
Dr. Rourke’s work also played a critical role in getting Canada’s first HIV self-test approved by Health Canada based in 2020.
More testing options are seen as vital tools in HIV prevention as it allows people to learn their status and get connect to treatment and care.
In Canada, an estimated 65,000 people live with HIV, the virus that causes AIDS, and 14 per cent of those are unaware of their status.
“Not everyone has access to the testing they need for STBBIs because of health inequities, stigma and various forms of discrimination,” said Dr. Rourke. “These tests are game-changers amid the rising number of STBBIs and will have real-life impacts.”
By Andrew Russell