Today, MedMira Inc. (MedMira) (TSXV: MIR) announces the achievement of another milestone in its regulatory strategy by receiving the CE mark for its Multiplo® Complete Syphilis (TP/nTP) Antibody Test (Multiplo® TP/nTP).
HALIFAX, Nova Scotia, May 12, 2022 (GLOBE NEWSWIRE) -- Today, MedMira Inc. (MedMira) (TSXV: MIR) announces the achievement of another milestone in its regulatory strategy by receiving the CE mark for its Multiplo® Complete Syphilis (TP/nTP) Antibody Test (Multiplo® TP/nTP). This approval allows the Company to further strengthen its product offering in all markets accepting the CE mark. By utilizing its unique RVF technology®, MedMira offers the only commercially available combined screening and confirmation test which takes less than 3 minutes (from sample collection to easy-to-read results) for syphilis.
“MedMira received the CE mark in March 2022 for its Reveal® TP (Syphilis) Antibody Test (Reveal® TP) aimed at diagnosing potential acute syphilis infections. The product is specifically designed for hospitals and health care providers which have an existing screening setting such as VDRL or RPR but require a fast confirmation test such as our Reveal® TP. MedMira’s Multiplo® TP/nTP, on the other hand, will provide a complete system which combines both screening and confirmation in one test. This product is designed for clients which do not have immediate access to VDRL or RPR such as doctor’s offices, pharmacies, and home test users.” says Hermes Chan, CEO of MedMira. ”Our Multiplo® TP/nTP further enhances our comprehensive product offering to our distribution partners and clients by providing a clear answer within minutes at the lowest possible cost. At the same time, it increases MedMira’s brand awareness in the sexually transmitted disease market.”
The Multiplo® TP/nTP combines the detection of treponemal (TP) and non-treponemal (nTP) antibodies in one test. The test targets biomarkers indicative of active as well as previous infections, thus providing a comprehensive approach that combines both the screening and confirmation stages employed in testing strategies globally. Unlike traditional syphilis testing options, our new easy-to-use, robust diagnostic solution is MedMira’s response to the growing demand for flexible, accurate and cost-efficient testing of syphilis. Multiplo® TP/nTP not only identifies exposure to TP but can determine the acute infection status through a non-treponemal screening test and a treponemal confirmation test. This enables a complete diagnosis of syphilis on one single device.
MedMira’s focus on syphilis is based on the tremendous impact of this sexually transmitted disease on global health. In 2018 alone, the European CDC reported about 34,000 new confirmed cases of syphilis with a 70% increase in the notification rate in 2017 compared to 2010. They also concluded that for the first time since the early 2000s EU/EEA countries reported more syphilis cases than HIV. Since treatments that can prevent the progression of syphilis are available, rapid diagnosis and treatment of infected individuals along with the rapid identification of sexual contacts is a high priority.
Next Update
MedMira will provide a COVID-19 update specifically for the Canada market in the coming week. Further updates on additional CE marks and other regulatory milestone such as the FDA will be provided within the month of May and June 2022.
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.
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MedMira Contact
Markus Meile
Chief Financial Officer
MedMira Inc.
ir@medmira.com
