NEW YORK (360Dx) – MedMira said today that it has received CE marking for its Multiplo TP/HIV multiplex rapid test, allowing the firm to market and distribute the test throughout the European Union, and in global markets that accept products with CE marking.
Multiplo TP/HIV enables simultaneous screening for HIV and Treponema pallidum, the causative agent of syphilis. The test provides results within minutes at the point-of-care, using MedMira’s rapid vertical flow technology platform, the firm said, adding that it is especially applicable in helping reduce the transmission of syphilis and HIV from mother to child.
It uses just a small sample of whole blood, serum, or plasma from a fingerstick or venipuncture, and delivers simultaneous results for syphilis and HIV in minutes rather than the hours or days needed for traditional laboratory testing, the firm added.
MedMira CEO Hermes Chan noted that the firm’s Multiplo TP/HIV tests deliver 100 percent sensitivity in identifying co-infections.
Each year 1.4 million women living with HIV become pregnant, and about 1 million pregnant women worldwide are infected with syphilis, the firm said in a statement, adding that global healthcare initiatives are targeting the elimination of the mother-to-child transmission route for HIV and syphilis, and many regions are seeing success with preventative testing.
Syphilis rates have been increasing across Europe since 2010, and many countries in Western Europe are seeing syphilis infection rates growing by more than 50 percent, MedMira said, citing statistics from the European Center for Disease Prevention and Control. 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, MedMira said.
MedMira said that its test is available through its European distributor network in three different product formats to meet the needs of users across a range of testing environments, including hospital and other laboratories, physician offices, pharmacies, and community and mobile testing sites.