MedMira Receives CE Mark for Syphilis/HIV Multiplex Rapid Test
Marketwired
HALIFAX, NOVA SCOTIA--(Marketwired - May 1, 2017) -
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MedMira Inc. (MedMira) (TSX VENTURE:MIR), a developer of rapid diagnostic technology platforms and testing solutions, has received CE Mark on its syphilis/HIV rapid test, Multiplo TP/HIV. This approval allows the Company to market and distribute the multiplex rapid test throughout the European Union (EU), where syphilis and HIV infection rates are on the rise, and in global markets that accept products with CE Marking.
Multiplo enables easy and accurate screening for both Treponema pallidum (TP), the causative agent of syphilis, and HIV simultaneously. Built on MedMira's distinctive Rapid Vertical Flow Technology platform, Multiplo provides instant results at the point-of-care, helping healthcare providers and their patients know more and begin treatment sooner. Multiplo TP/HIV is especially applicable in helping reduce mother-to-child transmission (MTCT) of syphilis and HIV. Global healthcare initiatives are targeting the elimination of the MTCT infection route for HIV and syphilis and many regions are seeing success with preventative testing. Each year 1.4 million women living with HIV become pregnant and nearly 1 million pregnant women worldwide are infected with syphilis annually.
"Independent studies led by our team in Canada and India and Canadian Institutes of Health Research funded meta-analyses have proved that point-of-care tests for HIV, Syphilis, and related co-infections, offer expedited screening solutions for pregnant women and marginalized populations for both resource rich and resource poor settings. Their high accuracies facilitate expedited clinical decision making, allow for same day triage to staging and treatment, and prevent loss to follow up of patients. Point-of-care technologies are the now and the future of diagnostics," said Dr. Nitika Pant Pai, MD., PHD and Associate Professor of Medicine at McGill University, and a medical scientist at the Research Institute of the McGill University Health Centre. "These technologies are game changers and form the backbone to achieving the first 90 of the UNAIDS 909090 initiative."
According to the European Center for Disease Prevention and Control (ECDC) in its latest Annual Epidemiological report syphilis rates have been increasing across Europe since 2010 with many countries in western Europe seeing a sharp rise in syphilis infections, with some countries' rates growing by over 50%. In 2014, Europe recorded the highest number of newly diagnosed HIV infections since the start of reporting in the 1980s and rates of HIV diagnoses have more than doubled in countries in eastern Europe.
"Our Multiplo TP/HIV tests delivers 100% sensitivity in identifying co-infections and is a key tool for healthcare providers, public health agencies, and aid organizations looking to maximize resources in their prevention and control initiatives," said Hermes Chan, CEO, MedMira Inc. "MedMira customers and their patients are benefiting from a higher throughput of patients tested and knowing their status, treatments started, and operational efficiencies achieved with Multiplo."
Alongside the Company's approved Reveal Rapid HIV Test and Miriad research product line, Multiplo is available through MedMira's European distributor network in three different product formats to meet the needs of all users across a broad range of testing environments including hospitals and laboratories, physician offices, pharmacies, as well as community and mobile testing sites. Multiplo uses just a small sample of fingerstick or venipuncture whole blood, serum or plasma in delivering simultaneous results for syphilis and HIV in minutes rather than the hours or days needed for traditional laboratory testing.
About MedMira
MedMira is a leading developer and manufacturer of vertical flow rapid diagnostics. The Company's tests provide hospitals, labs, clinics and individuals with instant diagnosis for diseases such as HIV and hepatitis C in just three easy steps. The Company's tests are sold under the Revealâ, Multiplo™ and Miriad™ brands in global markets. 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 approval and launch of new products, 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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