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StatSure's Patented HIV 'Barrel' Technology Receives CLIA Waiver From FDA
Date:11/5/2007

FRAMINGHAM, Mass., Nov. 5 /PRNewswire-FirstCall/ -- StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR.OB) announced today that the U.S. Food and Drug Administration ("FDA"), through its Center for Devices and Radiological Health, has approved a waiver under the Clinical Laboratory Improvements Amendments of 1988 ("CLIA") for an HIV 1/2 Rapid Test employing the Company's patented "barrel" technology. 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."

Specifically, the test has been waived for use in detecting HIV-1 and HIV-2 antibodies in human whole blood, serum, and plasma and demonstrates a sensitivity of 99.7% and a specificity of 99.9% in clinical trials. With this waiver, the CLEARVIEW (R) HIV-1/2 test can be used by more than 189,000 sites in the United States, including outreach clinics, community-based organizations and physicians' offices. StatSure's patented "barrel" technology is designed to maximize safety, convenience, performance and shelf-life and minimize exposure to infectious agents.

Steve Peltzman, CEO of StatSure, stated: "We are very excited about this achievement and the underlying markets that now may commercially be pursued." StatSure hopes to leverage this proprietary "barrel" format to develop and commercialize additional point-of-care rapid screening tests for other infectious disease.

ABOUT STATSURE

StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR - News) is engaged in the development, manufacture and marketing of rapid immunoassay tests for the detection of sexually transmitted and other infectious diseases; in addition, the Company h
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SOURCE StatSure Diagnostic Systems, Inc.
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