Chembio Diagnostics Announces Approval of Dengue Point-of-Care Test by Brazil’s Health Regulatory Agency

MEDFORD, N.Y., May 07, 2019 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the approval of its DPP Dengue System by Agência Nacional de Vigilância Sanitária (ANVISA), Brazil’s health regulatory agency, in collaboration with Bio-Manguinhos, a Brazilian government agency and supplier of diagnostic products to Brazil’s Ministry of Health.

Chembio’s DPP Dengue test allows simultaneous and discrete detection of antibodies against all four dengue serotypes for both active infection by dengue virus (IgM) and prior exposure to the dengue virus (IgG), 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 dengue 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, yielding sensitivity of 96.6% and 100% and specificity of 99.0% and 99.0%, for IgM and IgG antibody detection respectively.

“We are pleased to receive ANVISA approval for our dengue test, which shows high sensitivity and specificity, especially considering that the number of dengue cases in Brazil tripled compared to last year,” stated John Sperzel, Chembio’s Chief Executive Officer. “We now have multiple point-of-care tests available in Brazil and look forward to fulfilling the recently-announced initial order from Bio-Manguinhos for our dengue, chikungunya and Zika tests.”

Dengue is a mosquito-borne virus that is transmitted by female mosquitoes, mainly the species Aedes aegypti and, to a lesser extent, Aedes albopictus, which also transmit chikungunya, yellow fever and Zika viruses. Dengue is caused by a virus of the Flaviviridae family and there are 4 distinct, but closely related, serotypes of the virus that cause dengue (DEN-1, DEN-2, DEN-3 and DEN-4). According to the World Health Organization, there are nearly 400 million annual dengue infections and 3.9 billion people, in 128 countries, are at risk of infection with dengue viruses. According to the Pan American Health Organization (PAHO), Brazil has reported nearly 600,000 cases of dengue during 2019, including nearly 400 cases of severe dengue, and 169 dengue-related deaths.

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.

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Source: Chembio Diagnostics, Inc.