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CLIA Waiver Submitted for Rapid HIV Test Employs StatSure's 'Barrel' Technology
Date:8/19/2007

FRAMINGHAM, Mass., Aug. 14 /PRNewswire-FirstCall/ -- StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR - News) is pleased to announce that its patented, "barrel- test" format for the detection of antibodies to HIV-1/2 in human whole blood, serum, and plasma has completed the trials needed for a CLIA waiver application and that the results have been submitted to the United States Food & Drug Administration (FDA) for their review. The Company believes the results of these trials were consistent or superior to those of other rapid point of care products that have received a CLIA waiver. The HIV 1/2 product is marketed and distributed worldwide by Inverness Medical Innovations (Amex: IMA) under its Clearview(R) brand as "Clearview COMPLETE HIV 1/2". If CLIA waiver were granted for this product, it would greatly expand the available market for this product in the U.S. There are approximately 189,000 testing sites across the United States, including doctors' offices and clinics that require a test to be CLIA waived before it can be used. The United States Centers for Disease Control recommends HIV testing as part of the routine medical care of most Americans. On May 25, 2006, this HIV 1/2 test received marketing approval from the United States Food and Drug Administration's (FDA) Center for Biologics and Research (CBER) -- a prerequisite to submitting the CLIA Waiver Application.

According to Steve Peltzman CEO of StatSure: "Having this product CLIA waived should begin to capture the commercial potential of this product and allow SDS to go forward with its plan to expand the use of this format to other infectious diseases and to establish new strategic partnerships."

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SOURCE StatSure Diagnostic Systems, Inc.

Copyright©2007 PR Newswire.

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