bioLytical Receives CE Mark for HIV Self-Testing Kit

Monday, July 11, 2016 AIDS/HIV News J E 4

INSTI HIV Self Test will be available Online and in Retail locations across Europe

RICHMOND, BC, July 11, 2016 /PRNewswire/ - bioLytical Laboratories Inc., a world leader in rapid infectious disease tests, announced today that its INSTI® HIV Self Test has been granted CE Marking by European Union regulators. 


The INSTI HIV Self Test will be commercially available in the UK, France and other key European countries by the fourth quarter of this year. The product will be marketed through retail locations and certain e-commerce platforms.  INSTI is the world's fastest HIV Self Test providing instant results compared to other brands where individuals have to wait 15 to 20 minutes. With just one drop of blood, the INSTI Self Test can detect HIV antibodies two weeks sooner than any other HIV self-testing kit.  INSTI is simple to use and yields greater than 99% accuracy.

"The current point of care INSTI HIV-1/HIV-2 test is already a market leader in both France and the UK, and we are pleased to offer our Self Test to the many individuals who wish to test themselves in the privacy of their own home without the anxiety of waiting to learn their status," said Stan Miele, Chief Commercial Officer of bioLytical.

HIV testing is the foundation of the UNAIDS 90-90-90 initiative, which aims that by 2020, 90 percent of those living with HIV will know their HIV status, 90 percent of those individuals will be on antiretroviral therapy (ART), and 90 percent of individuals on ART will be virologically suppressed.  Just achieving the first 90% is a major undertaking.  As of 2014, of the estimated 2.5 million people in the World Health Organization (WHO) European Region living with HIV, approximately half were not even aware of their status. In 2014, 142,197 people were diagnosed with HIV in the region, the highest number ever recorded in one year.1 bioLytical is excited to be able to play an increasing role in helping to achieve this first 90 milestone with the approval of the INSTI HIV Self Test.

The INSTI HIV Self Test is an over-the-counter adaptation of the INSTI HIV-1/HIV-2 Antibody Test, which is approved by the FDA, Health Canada, has been WHO prequalified, European CE marked and currently sold in 57 countries globally.  It is a rapid, flow-through in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 in human fingerstick whole blood.  The INSTI HIV Self Test is intended for use by untrained lay users as an at home self-test to aid in the diagnosis of HIV infection using a single drop of blood.

About bioLytical Laboratories Inc.

bioLytical Laboratories Inc. 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.  With a world-wide footprint of regulatory approvals including US FDA approval, Health Canada approval and CE mark, bioLytical markets and sells its INSTI HIV test globally and INSTI HIV/Syphilis Multiplex test in Europe.  The INSTI product line provides highly accurate test results in 60 seconds or less, far faster than the 15-20 minutes required for competitors' tests based on lateral flow technology.  bioLytical has an active R&D program with a pipeline that includes tests for diseases such as Zika, Dengue, Chikungunya, Hepatitis C and Ebola, among others.  The company also provides contract services to adapt the INSTI platform to meet custom functional and technical diagnostic testing requirements.  For more information, please visit and


SOURCE bioLytical Laboratories



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