Health Canada approves MedMira’s rapid test for HIV and syphilis

Original from: Medical Device Network

Health Canada has granted approval to MedMira’s Multiplo Rapid TP/HIV Test, for HIV and syphilis in Canada.

The test enables healthcare professionals to simultaneously identify HIV-1/2 and syphilis antibodies from a single finger prick sample. It claims to deliver immediate outcomes, which is crucial for quick diagnosis and treatment initiation.

It is easy to use and there is no requirement for special ‘storage’ and can be used in various healthcare settings, from hospitals to doctors’ offices.

The licensure by the Canadian regulator is supported by the outcomes from a comprehensive clinical study conducted in Alberta, and co-led by REACH Nexus director and scientist with the MAP Centre for Urban Health Solutions at St. Michael’s Hospital (Unity Health Toronto) Dr Sean Rourke along with Dr Ameeta Singh from the University of Alberta.

MedMira CEO Hermes Chan said: “Our Multiplo TP/HIV device is the fastest testing solution 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.

“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.”

Dr Rourke’s research team, which played a pivotal role in the approval process, secured funding and conducted the landmark study from 2020 to 2022.

The study involved over 1,500 subjects from Edmonton and northern Alberta. It demonstrated the Multiplo TP/HIV test’s high accuracy rate of 100% for detecting HIV infection and more than 98% for identifying syphilis.

Following this approval, Health Canada is expected to soon authorise the single Reveal TP (Syphilis) test. This forthcoming approval will further enhance the diagnostic capabilities for syphilis in the Canadian healthcare landscape.

In February 2022, the company secured the CE mark for its Covid-19 test designed to detect the presence of total antibodies.

Source: Health Canada approves MedMira’s rapid test for HIV and syphilis