Point-of-Care Diagnostic for Trichomonas Vaginalis Based on MedMira's RVF Technology(R)

HALIFAX, NS / ACCESSWIRE / January 3, 2023 / Today, MedMira Inc. (MedMira) (TSXV:MIR) announces the publication of Point-of-Care Diagnostic for Trichomonas vaginalis, the Most Prevalent, Non-Viral Sexually Transmitted Infection - (available: https://www.mdpi.com/2076-0817/12/1/77), in the special edition of Pathogens by MDPI, a Swiss based medical journal. The article written by Professor John Alderete from the School of Molecular Biosciences, Washington State University, outlines the successful development of a POC diagnostic device for Trichomonas vaginalis based on MedMira's RVF Technology^®.

Dr. John Alderete discovered ACT::SOE3, a stable and highly sensitive biomarker for Trichomonas vaginalis, to be used for diagnostic purposes. Dr. Alderete required a rapid diagnostic technology to mobilize his developments and achieve a proof-of-concept and the required validation. MedMira's Miriad Rapid Vertical Flow Assay Toolkit was created to empower researchers and developers by offering an easy-to-use toolkit containing all components to create a high quality rapid test.

"We are impressed by how effective the RVF Technology^® can turn a concept into a functional product within a short timeframe. This revolutionary test will be an important tool for health care providers and individuals infected with T. vaginalis that will significantly help to provide a cost-efficient and high quality diagnostic tool for routine and universal screening of all age groups and of at-risk populations," said Dr. John Alderete. "With MedMira's technical support and our expertise in T. vaginalis research, I am very hopeful that this new test once becomes commercially available will enhance the reproductive health of women and men around world."

Trichomonas vaginalis, the causative agent for trichomoniasis, is the number one, non-viral Sexually Transmitted Infections (STI) with an estimated incidence of 156 million yearly cases worldwide. Studies have shown the extent of the prevalence and incidence numbers of T. vaginalis STIs among the age groups 15 to 59 years are high and indicates that this STI is both underreported and neglected. This is evident also in the studies that show the high numbers of undiagnosed, persistent infections, especially within certain racial/ethnic groups, such as among African Americans in certain settings. Most T.vaginalis STIs are asymptomatic, which contributes to chronic subclinical and adverse health outcomes for individuals. This STI causes maternal and perinatal morbidity and mortality, ectopic pregnancy, pelvic inflammatory disease, adverse birth outcomes, and congenital infections. T.vaginalis infections enhance the acquisition of HIV, which is disproportionately higher among African Americans. Recent literature continues to suggest a relation between T. vaginalis and prostate cancer. These facts reinforce the need for enhanced routine and universal screening to prevent the adverse morbidity by this STI in our country and worldwide.

"The New Year 2023 starts with another important milestone for our RVF Technology^® development. The collaboration effort between Dr. Alderete's group and our product development team, clearly demonstrates our leadership on the diagnostic development in addressing the significant increase of sexually transmitted infections globally", Hermes Chan. "This newly developed rapid POC test features the same advantages for fast turn around and high accuracy as found in our other infectious lines of product such as HIV, Hepatitis C and Syphilis".

Abstract

A point-of-care (POC) diagnostic is needed for both women and men to establish universal screening and surveillance for the number one, non-viral sexually transmitted infection (STI) caused by Trichomonas vaginalis. A POC diagnostic test was developed for this STI using the MedMira Rapid Vertical Flow (RVF Technology®) test cartridge with a membrane that includes a vertical procedural/reagent control line (referred to as CVL) and spotted actinin called ACT::SOE3. This protein is a specific diagnostic target for antibody in sera of individuals with trichomoniasis. Serum antibody to ACT::SOE3 is a positive reaction with

the test spot. Specificity of ACT::SOE3 was revealed with monoclonal antibodies (MAbs) generated to ACT::SOE3. Addition of negative control serum with MAb 67B reactive to ACT::SOE3 shows detection of both ACT::SOE3 and the CVL. Only positive sera of individuals had antibody reactive with ACT::SOE3 and detected the presence of the spot and the CVL. Negative control sera were unreactive with ACT::SOE3 and only showed the presence of the CVL. Importantly, to show proof-of-principle for POC application, ACT::SOE3 was detected with the positive patient sera spiked with whole blood. The prototypes have been extensively validated over the course of 12 months and show a high sensitivity.

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

SOURCE: MedMira, Inc.