MedMira receives CE Mark for syphilis/HIV rapid test
MedMira — which develops rapid diagnostic technology platforms and testing solutions — has received the CE Mark for its syphilis/HIV rapid test, Multiplo TP/HIV. This approval will allow the company to market and distribute the product throughout the EU and in global markets where CE Marking is accepted.
Built on the company’s Rapid Vertical Flow Technology platform, Multiplo provides results at the point-of-care and screens for both Treponaema pallidum (TP), which causes syphilis, and HIV simultaneously. This form of diagnostic is particularly applicable in the reduction of mother-to-child transmission (MTCT) of syphilis and HIV.
“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 marginalised 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,” said Dr Nitika Pant Pai, PhD, associate professor of medicines at McGill University and a medical scientist at the Research Institute of the McGill University Health Centre. “Point-of-care technologies are the now and the future of diagnostics. These technologies are game changers and form the backbone to achieving the first 90 of the UNAIDS 909090 initiative.”
According to the latest Epidemiological report from the European Center for Disease Prevention and Control (ECDC), rates of syphilis are increasing across Europe and have been since 2010. Many countries in western Europe saw a sharp increase in syphilis infections, with some countries seeing a rise of 50% in infection rates. Additionally, in 2014, Europe recorded the highest number of newly diagnosed HIV infections since reporting began in the 1980s and rates of HIV diagnoses have more than doubled in eastern European countries.
“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 organisations looking to maximise resources in their prevention and control initiatives,” added Hermes Chan, CEO of MedMira. “MedMira customers and their patients are benefitting from a higher throughput of patients tested and knowing their status, treatments started and operational efficiencies achieved with Multiplo.”