Industry Press Releases

Chembio Diagnostics Announces Approval of Zika, Dengue and Chikungunya Point-of-Care Multiplex Test by Brazil’s Health Regulatory Agency

Wednesday, Apr 10, 2019

Chembio Diagnostics, Inc., a leading point-of-care diagnostics company focused on infectious diseases, today announced the approval of its DPP Zika/Dengue/Chikungunya System by Agência Nacional de Vigilância Sanitária (ANVISA), Brazil’s health regulatory agency, in collaboration with Bio-Manguinhos/Fiocruz.

Chembio’s DPP Zika/Dengue/Chikungunya multiplex test allows simultaneous and discrete detection of antibodies for both active (IgM) and prior exposure (IgG) to the Zika, dengue, and chikungunya viruses, which is important for both treatment and surveillance. The test is performed using a small (10µL) drop of fingertip blood and provides quantitative results in approximately 15 minutes when used with the company’s handheld DPP Micro Reader. An evaluation of the multiplex test by Brazil’s Instituto Nacional de Controle de Qualidade em Saúde (INCQS) demonstrated outstanding analytical performance using patient samples in this highly endemic region, with all six results yielding sensitivity between 95.2% - 100% and specificity between 96.6% - 100%.

“Brazil faces a complex epidemiological scenario, characterized by simultaneous circulation of three arboviruses - Zika, dengue, and chikungunya - all transmitted by the Aedes aegypti mosquito,” stated John Sperzel, Chembio’s Chief Executive Officer. “Co-circulation hampers clinical differential diagnoses, as those arboviruses share common signs and symptoms. This ANVISA approval paves the way for commercialization in Brazil, and we believe our multiplex test will be an important tool in combating these serious diseases.”

This ANVISA approval advances Chembio’s previously announced commercial agreement with Bio-Manguinhos, a Brazilian government agency and supplier of diagnostic products to Brazil’s Ministry of Health, to develop and supply high-quality, rapid diagnostic tests for Zika, dengue, and chikungunya using Chembio’s DPP technology platform.

About Chembio Diagnostics
Chembio is a leading point-of-care diagnostics company focused on detecting and diagnosing infectious diseases. The company’s patented DPP technology platform, which uses a small drop of blood from the fingertip, provides high-quality, cost-effective results in approximately 15 minutes. Coupled with Chembio’s extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease, a number of which applications are under active development with collaboration partners. Chembio’s products are sold globally, directly and through distributors, to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers. Learn more at www.chembio.com.

Forward-Looking Statements
Statements contained in the third paragraph of this release that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the company and its management. Such statements, which are estimates only, reflect management's current views, are based on certain assumptions, and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the success of Chembio’s research, development and commercialization efforts and Chembio’s retention and attraction of key personnel. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.

DPP is our registered trademark. For convenience, this trademark appears in this release without ® symbols, but that practice does not mean that we will not assert, to the fullest extent under applicable law, our rights to the trademark.

Media contacts:

Chembio Diagnostics
Lynn Pieper Lewis
Gilmartin Group
(415) 937-5402
investor@chembio.com     

 

Source: globenewswire.com

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