INSTI HIV Self Test Receives Global Fund Classification for Procurement

bioLytical Laboratories, a world leader in rapid infectious disease tests, is pleased to announce that its INSTI HIV Self Test has been designated by the Global Fund as eligible for procurement by purchasing entities entitled to access Global Fund and UNITAID resources.

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The INSTI HIV Self Test is now eligible for procurement by organizations accessing Global Fund and/or UNITAID funding for their HIV self-test pilot programs that empower individuals to take control of their own health.

"We are very pleased to be awarded this designation by the Global Fund's Expert Review Panel," said Livleen Veslemes, Chief Operating Officer of bioLytical Laboratories. "In anticipation of significant global demand for a blood-based self-test, we placed a second automated bottling line into service earlier this year to augment the test device production equipment which is designed to produce 1 test per second. We are also investing further into process scale-up, facility optimization, warehouse expansion and evaluating automation of packaging to meet projections from international markets while maintaining the highest product quality standards."

The Global Fund's Expert Review Panel for Diagnostics is a mechanism to expedite access to innovative diagnostic products for one year. During this period, bioLytical will pursue World Health Organization prequalification along with approval from another stringent regulatory agency, such as CE marking, of its self-test version for low and middle income countries (LMICs).

Being a market leader in point-of-care HIV tests in major markets across Europe and North America, healthcare providers trust the INSTI brand because it delivers the accurate information and provides instant results for their patients. The INSTI product range is built on a strong foundation of peer-reviewed science and regulatory approvals and supported by over 14 years of expertise, quality, and innovation in medical diagnostics.

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, 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 http://www.biolytical.com.

Contact:
Robert Mackie,
info@biolytical.com,
+1-604-204-6784