Approval allows further expansion in Europe
RICHMOND, BC, Feb. 16, 2015 /CNW/ - bioLytical Laboratories Inc., a leading manufacturer of rapid point-of-care diagnostic tests, announced today that its INSTI™ HIV/Syphilis Multiplex Test has been cleared for immediate market entry in the European Union through its Notified Body. With this approval, the INSTI™ HIV/Syphilis Multiplex Test is available for simultaneous detection of Syphilis, HIV-1 and HIV-2 antibodies in as little as 60 seconds.
The Company is excited to add the INSTI Multiplex assay to its catalogue and to work closely with its distributors to launch the new product. The assay has been added to its existing CE certificates and is now listed alongside the INSTI HIV-1/2 Antibody Test as an approved device under Annex II List A of the European Council Directive 98/79 EC. This validation is critical because it confirms the preservation of the CE-Marked INSTI HIV assay performance characteristics combined with an accurate syphilis antibody assay on the same device.
According to the Centers for Disease Control and Prevention, individuals with a sexually transmitted infection (STI) are more likely to get HIV than those who are STI-free1 and co-infection of HIV and syphilis is a growing global concern. By providing screening for both infections simultaneously on one device in 60 seconds, the INSTI Multiplex assay offers a powerful tool for identifying individuals who need HIV and/or syphilis treatment, preventing mother-to-child transmission, and reducing the spread of both infections worldwide.
bioLytical's INSTI platform is unique because it allows for instant interpretation, while most rapid HIV and syphilis tests take about 20 minutes each to deliver results. By eliminating the time barrier, INSTI increases access to HIV testing at healthcare sites and creates new opportunities to test in novel settings. This is especially important among individuals who may not access these services through other avenues, those being tested for the first time, and those at highest risk of acquiring HIV who would benefit from repeated testing.
"We are extremely pleased to have received clearance to market the INSTI Multiplex assay in Europe," said Mr. Robert Mackie, Executive Chairman of bioLytical Laboratories. "This validation provides a vehicle for better servicing the testing community and allows us to aggressively pursue our distributor expansion strategy across Europe."
About bioLytical Laboratories
bioLytical Laboratories is a privately owned Canadian company engaged in the research, development and commercialization of rapid, point-of-care in vitro medical diagnostics using its proprietary INSTI™ technology platform. Today, the company markets and sells its signature INSTI™ HIV test and has a world-wide footprint of regulatory approvals including U.S. FDA approval, Health Canada approval and CE mark from European regulators. Their product provides a highly accurate HIV test result in as little as 60 seconds translating into a compelling value proposition for patients, healthcare professionals and public health organizations. For more information on bioLytical Laboratories, please visit www.biolytical.com.
1 CDC: HIV in the United States
SOURCE bioLytical Laboratories
For further information: CONTACT Mr. Robert Mackie, [email protected], 604-204-6784