HALIFAX, NS / ACCESS Newswire / January 21, 2025 / MedMira Inc. (MedMira) (TSXV:MIR) announced today that it 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.
More testing options are urgently needed amid soaring cases of syphilis and HIV in Canada, particularly in the Prairies. The upcoming trials for MedMira's self and non-profession test 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 testslicensed and into the Canadian market. One version would enable a person to self-administer a test for syphilis/HIV in their own home or in a place that suits them and will allow 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.
Infectious and congenital 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. Congenital syphilis occurs when a mother has untreated or inadequately treated syphilis before giving birth, and can lead to stillbirths in some cases. 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, according to the latest data.
Amid these soaring cases, particularly in underserved and remote communities in the Prairies, the Multiplo® TP/HIV rapid self-test and non-professional tests provides 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.
About REACH Nexus at St. Michael's Hospital's MAP Centre for Urban Health Solutions
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.Follow us on Twitter, Instagram and Facebook.
About MedMira
MedMira is a leading developer and manufacturer of Rapid Vertical Flow® diagnostics. The Company's tests provide hospitals, labs, clinics, and individuals with instant disease diagnosis, such as HIV, Syphilis, Hepatitis, and SARS-CoV-2, in just three easy steps. The Company's tests are sold globally under the REVEAL®, REVEALCOVID-19®, Multiplo®and Miriad® brands. Based on its patented Rapid Vertical Flow® Technology, MedMira's rapid HIV test is the only one inthe world to achieve regulatory approvals in Canada, the United States, China and the European Union. MedMira's corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada. For more information visit medmira.com. Follow us on Twitter and LinkedIn.
This news release contains forward-looking statements, which involve risk and uncertainties and reflect the Company's current expectation regarding future events, including statements regarding possible regulatory approval, product launch, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
MedMira Contact
Markus Meile
Chief Financial Officer
MedMira Inc.
ir@medmira.com
Phone 902-450-1588
REACH Nexus Contact
Andrew Russell
Senior Communications Specialist
REACH Nexus - MAP Centre for Urban Health Solutions
andrew.russell@unityhealth.to
Phone 647-237-2912
SOURCE: MedMira, Inc.
View the original press release on ACCESS Newswire
