bioLytical Completes Proof of Concept on 60 Second Zika, Dengue and Chikungunya Diagnostic Tests

RICHMOND, BC, March 22, 2016 /PRNewswire/ - bioLytical Laboratories, a world leader in rapid infectious disease tests, has successfully developed a pre-clinical prototype assay for the detection of antibodies to the Zika virus.  The test is able to detect anti-Zika antibodies in patient samples collected shortly after the onset of symptoms, indicating detection of IgM, which is critical for identification of early stages of infection.   

The prototype is developed on the Company's proven, accurate, and highly accepted INSTI rapid test platform, which is capable of providing results in as little as 60 seconds.  The pre-clinical test successfully detected anti-Zika antibodies from infected patient serum or plasma with minimal cross-reactivity with confirmed positive anti-Dengue or anti-Chikungunya sera.  Additional successful prototypes were created for detection of anti-Dengue and anti-Chikungunya antibodies, providing the option to develop either a multiplex test to simultaneously detect Zika, Dengue and Chikungunya virus infections, or individual stand-alone pathogen-specific tests.  With this successful proof of concept, the company is evaluating opportunities to accelerate the development of a Zika/Flavivirus test that would expand the INSTI rapid testing menu to include a response to this unmet public health need.  

"We are extremely excited about the INSTI platform's demonstration of early qualitative detection of these flaviviral infections.  The INSTI technology can detect IgM and IgG antibodies from fingerstick or venipuncture whole blood, plasma or serum," Rick Galli, bioLytical's Chief Technical Officer said in a statement. "We aim to be the first company to successfully develop a point of care diagnostic test which can provide results for Zika, Dengue and Chikungunya infections in 60 seconds."  

The Flaviviridae family has become a major concern in many areas of South America.  As of early February 2016, the Brazil Ministry of Health has estimated that 500,000 to 1,500,000 cases of Zika virus disease have occurred since the beginning of the outbreak.¹  Similarly, dengue has increased 30-fold over the last 50 years, which totals to an estimated 50-100 million infections annually in over 100 endemic countries.²  Comparably, since 2013, local transmission of Chikungunya has been identified in 45 countries or territories throughout the Americas with more than 1.7 million suspected cases.³  With the emergence and co-existence of these three diseases in a single population, a diagnostic assay that can rapidly detect and differentiate between them is of upmost importance.

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¹Garda, E. et al. (2016). Zika virus infection: global update on epidemiology and potentially associated clinical manifestations. World Health Organization – Weekly epidemiological record. 2016 Nov;91:73-88.
²World Health Organization – Dengue Control. Retrieved 14-03-2016 from http://www.who.int/denguecontrol/en/
³Centers for Disease Control and Prevention – Chikungunya Virus. Retrieved 17-03-2016 from http://www.cdc.gov/chikungunya/geo/

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 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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