StatSure Diagnostic
Systems, Inc. (OTC Bulletin Board: SSUR.OB) announced 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 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. Inverness Medical Innovations, Inc. (Amex: IMA), StatSure
Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR) and Chembio
Diagnostics, Inc. announced in October of 2006 agreements that provide
Inverness with exclusive worldwide marketing rights to Chembio’s
FDA-cleared, point of care, rapid test for the detection of antibodies to
HIV. The test utilizes Inverness’ proprietary lateral flow technology as
well as StatSure’s patented “barrel” technology designed to maximize ease
of use and minimize exposure to infectious agents.
Please visit our website at StatSure
FORWARD-LOOKING STATEMENTS This press release may contain
forward-looking statements within the meaning of the federal securities
laws. These statements reflect StatSure’s current views with respect to
future events and are based on management’s current assumptions and
information currently available. Actual results may differ materially due
to numerous factors, including without limitation, the future demand for
HIV testing products; our ability to successfully commercialize the
products; the intensely competitive environment in the relevant markets and
the risks and uncertainties described in periodic reports filed by StatSure
with the Securities and Exchange Commission under the federal securities
laws, including periodic reports on Form 10-Q or Form 10-QSB, as
applicable, for the period ended June 30, 2007. StatSure undertakes no
obligation to update any forward-looking statements contained herein.
StatSure Diagnostic Systems, Inc.
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