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Chembio Signs Agreement With CDC Contractor to Develop a Multiplex Point-of-Care Test for Influenza Immunity

Nov 24, 2014

MEDFORD, N.Y., Nov. 24, 2014 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced that it has entered into a follow-on, milestone-based development agreement with a private contracting organization acting on behalf of the United States Centers for Disease Control and Prevention (CDC), for a multiplex POC influenza immunity test utilizing Chembio's patented Dual Path Platform (DPP®) technology.

As a result of pandemic planning activities, the United States Department of Health and Human Services (HHS) and the CDC identified POC and high-throughput testing as a gap in influenza diagnostics. Rapid responses in the field — such as the vaccination, prophylactic treatment or isolation of patients — require POC diagnostic tests for influenza infection and immunity. Ideally, these tests should be fast, portable, self-contained and non-technical.

John Sperzel, Chembio's Chief Executive Officer, commented, "We are pleased to continue with this development program, which builds upon our experience and expertise developing multiplex POC assays using our proprietary DPP® technology, and we are pleased that the CDC and its contracting partner continue to see value in our DPP® technology. Our innovative and versatile DPP® technology is ideally suited to rapidly test for multiple influenza immunities, where rapid access to this information can guide treatment decisions and help avert widespread outbreaks."

The prior development work for a DPP® Influenza Immunity Assay was completed by Chembio between 2010 and 2013, pursuant to previous contracts with the same organization. The current project is being funded by the same organization and contemplates a timeline of three months to optimize the multiplex POC DPP® Influenza Immunity Assay to determine a person's influenza immunity status in the field or in an outpatient setting, while incorporating certain additional subunits of influenza virus proteins.

About Chembio Diagnostics

Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $8.0 billion point-of-care testing market. Chembio markets its DPP® HIV 1/2 Assay and HIV 1/2 STAT-PAK® Assay in the U.S. and internationally. The Company's SURE CHECK® HIV 1/2 Assay is marketed exclusively in the U.S. as Clearview® Complete. Outside the U.S., Chembio markets its SURE CHECK® HIV 1/2 Assays through distributors.

Chembio has developed a patented point-of-care test platform technology, the Dual Path Platform (DPP®) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products.

Headquartered in Medford, NY, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13485. Chembio Diagnostic Systems, Inc. is a wholly-owned subsidiary of Chembio Diagnostics, Inc. For more information, please visit: www.chembio.com.

Chembio's products are manufactured in the US by Chembio. For more information on any Chembio-branded products, please contact our customer service team at 1.844.CHEMBIO or visit us at: www.chembio.com.

Forward-Looking Statements

Statements contained herein 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 Chembio's ability to obtain additional financing and to obtain regulatory approvals in a timely manner, as well as the demand for Chembio's products. 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.

CONTACT: Chembio Diagnostics

         Susan Norcott

         (631) 924-1135, ext. 125

         snorcott@chembio.com



         Vida Strategic Partners (investor relations)

         Stephanie C. Diaz

         (415) 675-7401

         sdiaz@vidasp.com
Source: Chembio Diagnostics, Inc.

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