bioLytical Launches INSTI HIV Self Test for African Market in Response to New WHO Guidelines

The FDA approved, Health Canada approved, CE Marked and WHO Pre-Qualified professional use HIV assay has undergone a series of revisions and has been redesigned with extremely simplified pictorial instructions and supporting local language translations.  As part of the Company's mission to provide innovative solutions for diagnosis of infectious diseases, the Company is pleased to offer a low-cost self-test based on its internationally recognized professional use product.

"We have worked through each part of our supply chain to reduce costs from shipping, procurement, production and distribution to introduce this alternative format in response to the immense need for affordable self-testing in Africa," said Livleen Veslemes, bioLytical's Chief Operating Officer and Chief Financial Officer. "The HIV testing landscape is evolving and INSTI is well-suited to be a leader in the self-testing segment due to its simplicity and ability to provide instant, accurate results two weeks sooner than all other brands."

In advance of World AIDS Day, the World Health Organization (WHO) released new guidelines on HIV self-testing to improve access to and uptake of HIV diagnosis.

"By offering HIV self-testing, we can empower people to find out their own HIV status and also to notify their partners and encourage them to get tested as well," said Dr Gottfried Hirnschall, Director of WHO's Department of HIV. "This should lead to more people knowing their status and being able to act upon it. Self-testing will be particularly relevant for those people who may find it difficult to access testing in clinical settings and might prefer self-testing as their method of choice."

Self-testing has been shown to nearly double the frequency of HIV testing among men who have sex with men, and recent studies in Kenya found that male partners of pregnant women had twice the uptake of HIV testing when offered self-testing compared with standard testing.

The INSTI HIV Self Test (INSTI) is the world's fastest HIV test, providing instant results compared to other brands where individuals must wait 15 to 20 minutes.  With just one drop of blood, the assay 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 INSTI HIV Self Test is an over-the-counter adaptation of the INSTI HIV-1/HIV-2 Antibody Test, which has a world-wide footprint of regulatory approvals. It is a rapid, flow-through in vitro qualitative immunoassay for the detection of antibodies to HIV-1 and HIV-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 www.biolytical.com.

SOURCE bioLytical Laboratories

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