Navigation Links
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."

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.

Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the Company's ability to obtain additional financing and the demand for the Company's products. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC").


'/>"/>
SOURCE StatSure Diagnostic Systems, Inc.

Copyright©2007 PR Newswire.

Related medicine technology :

1. Rapid Whole Blood Testing for Infectious Mononucleosis Antibodies
2. Rapid Flu Tests May Prove Especially Helpful This Season
3. Point of Care Cardiac Analyzers Yield Rapid Cardiac Marker Results
4. Avian (Bird) Flu: Is There a Role for Rapid Tests?
5. Rapid HIV Testing Increases Possibility of Treatment
6. Rapid Response was Crucial to Containing the 1918 Flu Pandemic
7. West Nile Virus Screening and Diagnostics Technology Emerges In Step with North American Outbreak
8. Hematology Analyzers Simple, Sophisticated Technology Serving All Patients
9. Halozyme Therapeutics Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society
10. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
11. Generex Biotechnology to Make Presentations At 46th Annual Meeting of the European Society of Pediatric Endocrinology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... , March 23, 2017 The ... ageing population, increasing diabetic population, accelerating economic growth and increasing ... this industry are higher life expectancy of ESRD patients, rising ... emerging markets. However, the expansion of the market is hindered ... ...
(Date:3/23/2017)... , March 23, 2017 As ... years along with the prevalence of allergic diseases, ... measures are currently revolutionising the ways in which ... Allergies 2017 promises to be both a ... amongst the allergy interest groups, immunologists, research scholars ...
(Date:3/23/2017)... AUSTIN, Texas , March 23, 2017 /PRNewswire/ ... www.digitalpharmacist.com ), a rapidly growing digital ... PocketRx, a mobile app that allows patients to ... including multi-store locations such as Denver Health Pharmacy, ... app. The acquisition helps Digital Pharmacist accelerate its ...
Breaking Medicine Technology:
(Date:3/23/2017)... ... March 23, 2017 , ... Michael Lanteri Agency, an ... Fort Collins area, has unveiled a collaboration with nonprofit Big Bones Canine Rescue ... this worthy cause may now be made at http://bigbonescaninerescue.com/ . , Big ...
(Date:3/23/2017)... ... March 23, 2017 , ... Altec Products, Inc. ... Group as their 2016 Microsoft Dynamics Partner of the Year at DocLink ... The award recognizes The Resource Group for their outstanding relationship with Altec and ...
(Date:3/23/2017)... ... , ... Sharon Kleyne, host of the nationally syndicated radio program, The Sharon ... talked on her program about how she is looking forward to World Water Day ... important distinction. World Water Day, Kleyne pointed out, is an occasion for looking ahead ...
(Date:3/23/2017)... Kennett Square, PA (PRWEB) , ... March 23, 2017 , ... ... sunny days. That means many students are thinking about summer internships , which ... (or lack thereof). , The pros at Garden Media Group, a boutique public relations ...
(Date:3/23/2017)... ... March 23, 2017 , ... The American Board of Quality Assurance ... Anniversary of ABQAURP’s dedication to Health Care Quality and Management and Patient Safety. , ... only to the association, but also to the Health Care Quality and Patient Safety ...
Breaking Medicine News(10 mins):