Navigation Links
StatSure's Patented HIV 'Barrel' Technology Receives CLIA Waiver From FDA

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.


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

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.

SOURCE StatSure Diagnostic Systems, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Quantum light beams good for fast technology
2. New Smart Technology Makes Patient Data Collection Easier, More Efficient
3. Align Technology Executive to Present at Upcoming Financial Conferences
4. Pioneer Surgical Technology Hires Vice President of New Business Development
5. Purdue researchers develop technology to detect cancer by scanning surface veins
6. Creative Technology Services Enhances its Global Competitiveness with Additional Regulatory Certifications
7. University of Wisconsin Hospitals and Clinics Complete System-Wide Conversion to Masimo SET Pulse Oximetry Technology
8. Patent Reform Legislation Threatens Americas Leadership in Medical Technology Innovation
9. Stevens Health, Technology and Society roundtable: Sept. 19
10. Microbiotic technology developed for microinjection of zebrafish embryos
11. Proven Terumo Coronary Guidewire Technology Is Now Available in the United States
Post Your Comments:
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet ... product that was developed to enhance the health of felines. The formula is all-natural ... two main herbs in the PawPaws Cat Kidney Support Supplement Soft Chews ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes ... important health care topics including advance care planning, healthcare costs and patient and ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, ... Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms ... Final Cut Pro X . Simply select a ProHand generator and drag it above ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson ... Recently, he has implemented orthobiologic procedures as a method for treating his patients. ... the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published ... unfamiliar with. The article goes on to state that individuals are now more comfortable ... less common operations such as calf and cheek reduction. The Los Angeles area medical ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... According to a new market ... Needles, Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, ... of Purchase (Retail, Non-Retail) - Trends & Global Forecasts ... market for the forecast period of 2016 to 2021. ... by 2021 from USD 1.65 Billion in 2016, growing ...
(Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
(Date:6/23/2016)... , June 23, 2016  In a startling report released today, ... their residents by lacking a comprehensive, proven plan to eliminate prescription ... definitive ranking of how states are tackling the worst drug crisis ... four states – Kentucky , New ... Vermont . Of the 28 failing states, three – ...
Breaking Medicine Technology: