FRAMINGHAM, Mass., Aug. 14 StatSure DiagnosticSystems, Inc. (OTC Bulletin Board: SSUR - News) is pleased to announce thatits patented, "barrel- test" format for the detection of antibodies to HIV-1/2in human whole blood, serum, and plasma has completed the trials needed for aCLIA waiver application and that the results have been submitted to the UnitedStates Food & Drug Administration (FDA) for their review. The Company believesthe results of these trials were consistent or superior to those of otherrapid point of care products that have received a CLIA waiver. The HIV 1/2product is marketed and distributed worldwide by Inverness Medical Innovations(Amex: IMA) under its Clearview(R) brand as "Clearview COMPLETE HIV 1/2". IfCLIA waiver were granted for this product, it would greatly expand theavailable market for this product in the U.S. There are approximately 189,000testing sites across the United States, including doctors' offices and clinicsthat require a test to be CLIA waived before it can be used. The United StatesCenters for Disease Control recommends HIV testing as part of the routinemedical care of most Americans. On May 25, 2006, this HIV 1/2 test receivedmarketing approval from the United States Food and Drug Administration's (FDA)Center for Biologics and Research (CBER) -- a prerequisite to submitting theCLIA Waiver Application.
According to Steve Peltzman CEO of StatSure: "Having this product CLIAwaived should begin to capture the commercial potential of this product andallow SDS to go forward with its plan to expand the use of this format toother infectious diseases and to establish new strategic partnerships."
StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR - News) isengaged in the development, manufacture and marketing of rapid immunoassaytests for the detection of sexually transmitted and other infectious diseases;in addition, the Company has developed and is marketing a product line ofpatented, oral- fluid collection devices. The Company's proprietary platformsprovide significant customer benefits and competitive advantages as comparedto similar products that are currently available. Improved accuracy, operatorconvenience, and reduced risk of infection from collecting and handlingspecimens, have been engineered into SDS products. All of the company'sdiagnostic tests are based on the same easy-to-use technology platform, thusfacilitating the development of future products. Certain of these products aresold in the United States as well as internationally to various distributorsfor use in clinical laboratories, hospitals, clinics, community-basedorganizations and other public health organizations.
Statements contained herein that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, asamended. Those statements include statements regarding the intent, belief orcurrent expectations of the company and its management. Such statementsreflect management's current views, are based on certain assumptions andinvolve risks and uncertainties.
Actual results, events, or performance may differ materially from theabove forward-looking statements due to a number of important factors, andwill be dependent upon a variety of factors, including, but not limited to,the Company's ability to obtain additional financing and the demand for theCompany's products. The Company undertakes no obligation to publicly updatethese forward-looking statements to reflect events or circumstances that occurafter the date hereof or to reflect any change in the Company's expectationswith regard to these forward-looking statements or the occurrence ofunanticipated events. Factors that may impact the Company's success are morefully disclosed in the Company's most recent public filings with the U.S.Securities and Exchange Commission ("SEC").