CLIA Waiver Submitted for Rapid HIV Test Employs StatSure's 'Barrel' Technology
Tuesday August 14, 8:30 am ET
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 - News) under its Clearview® 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."
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 has developed and is marketing a product line of patented, oral- fluid collection devices. The Company's proprietary platforms provide significant customer benefits and competitive advantages as compared to similar products that are currently available. Improved accuracy, operator convenience, and reduced risk of infection from collecting and handling specimens, have been engineered into SDS products. All of the company's diagnostic tests are based on the same easy-to-use technology platform, thus facilitating the development of future products. Certain of these products are sold in the United States as well as internationally to various distributors for use in clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations.
Forward-Looking Statements
Statements contained herein that are not historical facts are forward- looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the company and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties.
Source: StatSure Diagnostic Systems, Inc.
The SEC Must Go!
And jail shorters.
