MedMira's New HIV/Syphilis Tests: A Game Changer for Canada's Health Crisis

MedMira Inc. (TSXV:MIR) has received Investigational Testing Authorizations (ITAs) from Health Canada to begin clinical trials for new label claim applications of its recently Health Canada approved Multiplo® TP/HIV rapid test. These applications include use as a self-test and for non-professional administration, expanding access to testing for syphilis and HIV in Canada. This significant development comes amid soaring cases of syphilis and HIV, particularly in the Prairies, and addresses the urgent need for more rapid testing options.

The upcoming trials for MedMira's self and non-professional tests will be led by REACH Nexus at the MAP Centre for Urban Health Solutions at St. Michael's Hospital (Unity Health Toronto) with funding from the Canadian Institutes of Health Research (CIHR). The ITA approval is an important step towards getting the Multiplo® TP/HIV rapid self-test and non-professional tests licensed and into the Canadian market.

One version of the test would enable a person to self-administer a test for syphilis/HIV in their own home or in a place that suits them, allowing people to safely discover their status in minutes. MedMira's non-professional device allows for a peer or non-professional healthcare worker to administer the test, providing yet another option for people who experience barriers to accessing healthcare.

These easy-to-use, accurate tests detect both HIV-1/2 and syphilis antibodies using one blood sample from a single finger prick that delivers results immediately. If positive, the person can then have their results confirmed by a lab-based test and get connected to treatment.

"These ITAs are significant steps toward making the Multiplo® TP/HIV rapid test available for self-testing and non-professional use in Canada," said Hermes Chan, CEO of MedMira. "With these applications, individuals can safely and quickly determine their status in a setting that works best for them, whether at home or in community-based environments, helping to remove barriers to care and address rising infection rates."

The approved Multiplo® TP/HIV rapid test is easy to use, providing immediate results from a single finger-prick blood sample. It detects both syphilis and HIV antibodies, and if positive, individuals can confirm their results through lab-based testing and connect to treatment.

The latest data from the Public Health Agency of Canada shows that new HIV diagnoses have 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. In 2022, there were 13,953 reported syphilis cases, with rates increasing by 109 per cent compared to 2018. Congenital syphilis cases have seen a 7 per cent increase from 2021 and a nearly 600 per cent increase from 2018, with 15 stillbirth deaths in 2022.

Amid these soaring cases, particularly in underserved and remote communities in the Prairies, the Multiplo® TP/HIV rapid self-test and non-professional tests provide a "missing key" to help reach the undiagnosed living with HIV and/or syphilis.

"HIV self-testing can help open the door to reach the more than 8,000 people in Canada who have HIV and don't know it," said Dr. Sean B. Rourke, the director of REACH Nexus and a scientist at the MAP Centre for Urban Health Solutions. "We still don't have exact numbers of how many people have current infectious syphilis that is still undiagnosed, but we know the numbers are very high, and need immediate interventions".

"Many people from vulnerable communities do not come forward for testing because of stigma or negative experiences with traditional healthcare systems. Having more accessible tests, like MedMira's, create low barrier options for people to get tested so they know their status, and to start getting connecting to treatment and care."

With funding from the Canadian Institutes of Health Research (CIHR), Dr. Rourke and his team at REACH Nexus are launching its "test, treat, and connect" community-based clinical trials that will involve roughly 1,700 participants in Ontario, Manitoba, and British Columbia. REACH will work closely with researchers, doctors, registered nurses and healthcare partners, and peers at organizations like Women's Health In Women's Hands in Toronto, Nine Circles Community Health Centre in Winnipeg, and The Victoria Cool Aid Society in B.C.

MedMira's new label claim applications for the Multiplo® TP/HIV rapid test have the potential to significantly impact the company's revenue growth and market share in Canada. The expanded accessibility and increased demand for testing solutions, particularly in underserved and remote communities, will drive revenue growth. Additionally, the test's high accuracy and ease of use offer advantages to both healthcare professionals and individuals, making it an attractive option in the Canadian HIV and syphilis testing market.

However, implementing and scaling up the Multiplo® TP/HIV rapid self-test and non-professional tests in underserved and remote communities presents several challenges. Accessibility and distribution, affordability, education and awareness, connecting to care, and addressing stigma and discrimination are key obstacles that MedMira must address through strategic partnerships, education, and support.

In conclusion, MedMira's new label claim applications for the Multiplo® TP/HIV rapid test offer a significant opportunity to combat the rising cases of HIV and syphilis in Canada, particularly in underserved and remote communities. By addressing the challenges and working closely with stakeholders, MedMira can help ensure that these tests reach those who need them most, ultimately helping to combat the health crisis.