MEDFORD, NY -- (MARKET WIRE) -- 06/27/08 -- Chembio Diagnostics, Inc. (OTCBB: CEMI)("Chembio" or the "Company") reported today, National HIV Testing Day, thatit has completed a clinical study designed to evaluate the performance ofits two FDA (United States Food & Drug Administration) approved rapid HIVtests on a pediatric subpopulation (ages 13-17 years of age). The objectiveof this study was to ascertain the ability of these tests to detect HIVantibodies in this patient population using various sample matrices --serum, plasma and fingertip or venous whole blood. The objective of theclinical study was achieved and, pending a satisfactory review of the databy the FDA, Chembio anticipates extending the age range of testing topediatric subjects that are 13 years of age and above. The trial,conducted at the Laboratory of Viral Diagnostics, University of MarylandSchool of Medicine, enrolled patients with confirmed HIV-positive status.Additional analyses were performed using standard laboratory reference testmethods.The results of the clinical study meet the requirements established withthe FDA during the design phase of the clinical protocol and will besubmitted as a supplement to each of Chembio's two FDA-approved premarketapplications (PMAs) covering Chembio's rapid HIV tests being marketed inthe United States by Chembio's exclusive U.S. marketing partner.
Chembio's Chairman and President, Lawrence A. Siebert, commented, "Weanticipate that the successful completion of this trial will enable Chembioto expand the age claims of testing with these assays so as to fully meetthe U.S. Centers for Disease Control and Prevention (CDC) recommendationsthat routine screening for HIV be performed on all patients ages 13 to 64years of age. Routine testing is essential to enable individuals to knowtheir status, to prevent transmission and to improve treatment outcomes,and we are proud to have products that serve this objective."
ABOUT CHEMBIO
Chembio Diagnostics, Inc. develops, manufactures, licenses and marketsproprietary rapid diagnostic tests in the growing $5 billion point-of-caretesting market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIVtests are marketed in the U.S. by a third party company. Chembio marketsits HIV STAT-PAK® line of rapid HIV tests internationally to governmentand donor-funded programs directly and through distributors. Chembio alsohas rapid tests for veterinary tuberculosis and chagas disease. In 2007Chembio received a U.S. patent for its Dual Path Platform (DPP(TM))technology which has significant advantages over lateral-flow technologies.This technology is providing Chembio with a significant pipeline ofbusiness opportunities for the development and manufacture of new productsbased on DPP(TM). Headquartered in Medford, NY, with approximately 100employees, Chembio is licensed by the U.S. Food and Drug Administration(FDA) as well as the U. S. Department of Agriculture (USDA), and iscertified for the global market under the International StandardsOrganization (ISO) directive 13.485.
FORWARD-LOOKING STATEMENTS
Statements contained herein that are not historical facts may beforward-looking statements within the meaning of the Securities Act of1933, as amended. Forward-looking statements include statements regardingthe intent, belief or current expectations of the Company and itsmanagement. Such statements are estimates only, as the Company has notcompleted the preparation of its financial statements for those periods,nor has its auditor completed the audit of those results. Actual revenuemay differ materially from those anticipated in this press release. Suchstatements reflect management's current views, are based on certainassumptions and involve risks and uncertainties. Actual results, events, orperformance may differ materially from the above forward-looking statementsdue to a number of important factors, and will be dependent upon a varietyof factors, including, but not limited to Chembio's ability to obtainadditional financing, to obtain regulatory approvals in a timely manner,and the demand for Chembio's products. Chembio undertakes no obligation topublicly update these forward-looking statements to reflect events orcircumstances that occur after the date hereof or to reflect any change inChembio's expectations with regard to these forward-looking statements orthe occurrence of unanticipated events. Factors that may impact Chembio'ssuccess are more fully disclosed in Chembio's most recent public filingswith the U.S. Securities and Exchange Commission.
Company Contact:
Chembio Diagnostics, Inc.
Susan Norcott
(631) 924-1135, ext. 125
(www.chembio.com)
