HAUPPAUGE, NY, July 20, 2021 (GLOBE NEWSWIRE) – Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious disease, today announced that it has received a purchase order of 28.3 million dollars from Bio-Manguinhos for the purchase of the DPP SARS-CoV-2 antigen tests from Chembio for delivery in 2021 to meet the urgent needs of the Brazilian Ministry of Health for deal with the COVID-19 pandemic. The SARS-CoV-2 Antigen DPP test is designed to detect the SARS-CoV-2 antigen, which indicates an active COVID-19 infection, in just 20 minutes using a minimally invasive nasal swab. Chembio’s delivery of the total number of tests covered by the PO may be affected by Chembio’s supply chain, personnel and liquidity limitations, and other matters beyond Chembio’s control.
Bio-Manguinhos, a subsidiary of the Oswaldo Cruz Foundation (Fiocruz), is responsible for the development and production of vaccines, diagnostics and biopharmaceuticals, primarily to meet the demands of Brazil’s national public health system. Chembio has a long-standing relationship with Bio-Manguinhos, having supplied several products for the point-of-care detection of COVID-19 antibodies, HIV and other infectious diseases. Bio-Manguinhos received regulatory approval from AgÃªncia Nacional de VigilÃ¢ncia SanitÃ¡ria (ANVISA) in March 2021, following the approval of the test by ANVISA for the Brazilian subsidiary of Chembio in November 2020.
âWe are delighted to significantly expand our customer relationship with Bio-Manguinhos to meet the testing needs surrounding COVID-19,â said Javan Esfandiari, Executive Vice President of Chembio, Chief Scientific and Technological Officer. âEnabling providers to test patients at the point of care and determine their infection status in just 20 minutes may be one of the most effective methods of controlling the spread of COVID-19 and improving patient outcomes. We believe the purchase order validates the investments we made earlier this year in the PLR ââSARS-CoV-2 Antigen test inventory and look forward to ramping up production. We are very proud to provide this test to Brazil and to contribute to the efforts to manage the global pandemic. “
About the DPP Rapid Test Platform
Chembio’s proprietary DPP technology platform delivers fast, high-quality diagnostic results in 15-20 minutes using a small drop of fingertip blood or other samples. Using advanced multiplexing, the DPP platform can detect up to eight distinct test results from a single patient sample, providing greater clinical value than other rapid tests. For some applications, the easy-to-use, highly portable, battery-powered DPP Micro Reader optical analyzer then reports accurate results in about 15 seconds, making it well suited for decentralized testing where real-time results allow patients to be clinically evaluated. while they are still there. The objective results produced by the DPP Micro Reader reduce the possibility of the types of human error that may be encountered in visual interpretations required by many rapid tests.
The DPP-based point-of-care testing portfolio with FDA regulatory approvals includes DPP HIV-Syphilis System (PMA Approved), DPP HIV 1/2 Test (PMA Approved and CLIA Dispensed), DPP Zika System IgM (510 (k)) and DPP Ebola Antigen System (EUA). Additionally, the DPP-based tests have received regulatory approvals from the World Health Organization, CE Mark, ANVISA, and other global organizations, where they aid in the detection and diagnosis of several more. critical illnesses and conditions.
All DPP tests are developed and manufactured in the United States and are the subject of a range of national and global patents and pending patents.
About Chembio Diagnostics
Chembio is a leading point-of-care diagnostic company focused on the detection and diagnosis of infectious diseases, including COVID-19, sexually transmitted diseases, respiratory diseases, and insect vector-borne diseases. Coupled with Chembio’s vast scientific expertise, its new DPP technology offers broad market applications beyond infectious diseases. Chembio’s products are sold worldwide, 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.
Certain statements contained in the first and third paragraphs above are not historical facts and may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding intent, belief or current expectations with respect to the manufacture, distribution and sale of the DPP SARS-CoV-2 Antigen assay in accordance with the Bio-Manguinhos purchase order. These statements, which are only expectations, reflect the current views of management, are based on certain assumptions and involve risks and uncertainties. Actual results, events or performance may differ materially from forward-looking statements due to a number of important factors, and will depend on various factors, including, but not limited to the following, each of which could be further exacerbated. by the continuing outbreak of COVID-19 in the United States, Brazil and around the world: constraints on Chembio’s supply chain, personnel and other resources that could hamper Chembio’s ability to supply the number of tests envisaged by the order form of Bio-Manguinhos; the need for Chembio to secure sufficient working capital to finance the sourcing of raw materials, employment and staffing, and other costs associated with manufacturing testing, as well as Chembio’s continued operational infrastructure ; the risks of doing business with foreign government entities, including geopolitical, international and other challenges; the ability of Chembio and Bio-Manguinhos to maintain existing regulatory approvals and to obtain timely additional regulatory approvals for its COVID-19 diagnostic tests, which approvals are subject to processes that may change on a recurring basis without notice; Chembio’s addiction and his limited experience with COVID-19 diagnostic tests; and the highly competitive and rapidly developing market for testing solutions for COVID-19, which includes a number of competing companies with strong relationships with current and potential customers, including government authorities, and with financial resources and others much more important at Chembio’s disposal. . Chembio does not undertake to publicly update any forward-looking statements in this press release to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio’s expectations with respect to forward-looking statements or the occurrence of unforeseen events. Factors that may affect Chembio’s success are more fully disclosed in Chembio’s periodic public filings with the United States Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year. ended December 31, 2020 and its subsequent quarterly reports on Form 10-Q and current reports on Form 8-K, in particular under the heading âRisk Factorsâ. Readers should interpret many of the risks identified in these reports as heightened due to the many continuing negative impacts of the COVID-19 pandemic.
DPP is the registered trademark of Chembio. For convenience, this mark appears in this press release without the Â® symbols, but this practice does not mean that Chembio will not assert, to the fullest extent of applicable law, its rights in the mark.