MedMira Receives Health Canada Approval for Its Reveal(R) G4 Rapid HIV-1/2 Test for Point-of-Care Use

HALIFAX, NS / ACCESSWIRE / January 14, 2025 / MedMira Inc. (MedMira) (TSXV:MIR) announced today that it has received today the approval from Health Canada for its Reveal®Rapid G4 HIV-1/2 Test (Reveal® HIV test) for Point-of-Care (POC) use. The Reveal® HIV rapid test has achieved a sensitivity of 99.64% and a specificity of 99.71% and with it is highly suitable for health care professionals who require a fast, reliable, and high-quality result to be used in any health care setting.

The Reveal® HIV test enables an immediate result to accurately detect HIV-1/2 antibodies with only a small sample using a finger prick. The less then 1-minute easy steps to complete the test (after sample collection), allows an operator to achieve an immediate result that does not fade away. This together with the no special storage requirement makes the Reveal® HIV test a highly suitable tool for any health care setting.

The product is based on MedMira’s unique and patented Rapid Vertical Flow Technology® with an in-build reagent and procedural control line which enables users to be sure the test is performed correctly. This distinctive feature provides the comfort and security that a test has been correctly completed. An essential part for any rapid testing, especially for life changing diagnoses such as HIV.

“Our REVEAL® HIV test is one of the fastest and most reliable solutions for HIV detection. As the rates of HIV infections continue to rise in Canada, healthcare providers need diagnostics that are not only accurate but also simple, cost-effective, and accessible in any setting. Whether in underserved remote areas or urban centres facing overburdened healthcare systems, our test is designed to provide immediate and actionable results. ,” said Hermes Chan, CEO of MedMira. “Together with our partners, such as REACH Nexus, we are committed to rapidly deploying our innovative solutions and supporting Canada’s public health efforts to modernize and expand HIV screening.”

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.

This approval comes after the received approval of MedMira’s Multiplo® TP/HIV rapid test on the 24^th of December 2024. The Company’s aim is to provide the Canadian market with a suite of alternatives as certain health care settings and programs or professionals aim for a specific disease. Hence the Company offers its Multiplo® TP/HIV combination test or its Reveal® single marker tests such as Reveal® HIV test. MedMira anticipates the approval of the Reveal® TP test in the coming weeks.

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 in the 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

SOURCE: MedMira, Inc.

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