MEDFORD, NY--(Marketwire - September 23, 2010) - Chembio Diagnostics, Inc. (OTCBB: CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, has been notified that Bio-Manguinhos, a division of the Oswaldo Cruz Foundation of Brazil ("FIOCRUZ"), has received regulatory approval from Brazil's National Health Surveillance Agency ("ANVISA") to market Chembio's Dual Path Platform (DPP®) HIV 1/2 Confirmatory rapid test for use with whole blood, serum or plasma samples. The approval triggers a $225,000 initial payment to Chembio.
FIOCRUZ (www.fiocruz.br) is a world-renowned public health organization affiliated with the Brazilian Ministry of Health and is the Ministry's leading supplier for therapeutics, vaccines and diagnostic tests dedicated to public health. FIOCRUZ has entered collaborations with some of the world's leading biotechnology companies in fulfillment of its mission.
This is the second DPP® test developed by Chembio to receive regulatory approval in Brazil in the last three months. In June, the Company reported approval of its DPP® oral fluid HIV 1/2 screening test by ANVISA. This is however the first DPP® multiplex test employing Chembio's patented Dual Path Platform to received regulatory approval. One of the unique features of DPP® is its enabling of multiple parameter tests to be developed. The confirmatory test uniquely detects five different strains of HIV in a single point-of-care device.
During 2008 Chembio signed four agreements with FIOCRUZ relating to products based on the Company's DPP® technology, including this HIV confirmatory test. Previous to that, in 2004, Chembio and FIOCRUZ entered a successful collaboration pertaining to Chembio's HIV 1/2 STAT-PAK®. Under the DPP® HIV 1/2 Confirmatory rapid test agreement with FIOCRUZ, a technology transfer to FIOCRUZ for this product is contracted for, which is anticipated to occur in stages over a three-year period. During that period the agreement provides for minimum sales by Chembio to FIOCRUZ for this product and related components of approximately $4.7 million. Thereafter, it is anticipated that the technology transfer process will be completed. The agreement for the previously approved oral fluid HIV test, combined with this agreement pertaining to the HIV confirmatory test, represent combined potential aggregate sales of at least $13.5 million based on the minimum sales required under these agreements in order to complete the technology transfer.
Lawrence Siebert, Chembio's Chief Executive Officer, said, "This product approval is an important milestone relating to our DPP® technology, as it very clearly demonstrates the capabilities of our platform, replacing time-consuming, laboratory-dependent tests with products that can provide critical information at the point of care."
About Chembio Diagnostics
Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $7 billion point-of-care testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the U.S. by Alere North America, Inc. (formerly Inverness Medical Innovations, Inc.). Chembio markets its HIV STAT-PAK® line of rapid HIV tests internationally to government and donor-funded programs directly and 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 based on DPP®. Headquartered in Medford, NY, with approximately 100 employees, 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 13.485. For more information, please visit: www.chembio.com.
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 are estimates only, as the Company has not completed the preparation of its financial statements for those periods, nor has its auditor completed a review or audit of those results. Actual revenue may differ materially from those anticipated in this press release. Such statements 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, to obtain regulatory approvals in a timely manner and 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.