Mr. Markus Meile reports

MEDMIRA RECEIVES INVESTIGATIONAL TESTING AUTHORIZATIONS FOR MULTIPLO(R) TP/HIV SELF-TEST AND NON-PROFESSIONAL USE APPLICATIONS

Medmira Inc. 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 toward getting the Multiplo TP/HIV rapid self-test and non-professional tests licensed 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 health care worker to administer the test providing yet another option for people who experience barriers to accessing health care.

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, chief executive officer 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 with 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 health care 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 health care 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 Medmira Inc.

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, N.S., Canada.

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