Ubertino
14 years ago
Chembio Initiates Pre-IDE Studies for Home Use of Sure Check(R) Rapid HIV Test
June 27, 2011, 6:18 a.m. EDT
MEDFORD, NY, Jun 27, 2011 (MARKETWIRE via COMTEX) -- Chembio Diagnostics, Inc. (otcqb:CEMI) CEMI -2.15% ("Chembio" or the "Company"), which develops, manufactures, markets and licenses point-of-care diagnostic tests, has initiated studies required for submission of an Investigational Device Exemption (IDE) to the Food and Drug Administration for its Sure Check(R) rapid HIV Test as the first step toward over-the-counter (OTC) product approval. This is the first of Chembio's FDA-approved rapid HIV tests that it will target for the at-home market.
The first step toward approval is to submit an investigational device exemption (IDE). Chembio believes that a market study of the intended users and an additional "Flex" Study are required to complete the IDE submission. Both of these studies have been initiated and Chembio plans to complete both of these studies and submit an IDE to the FDA during the latter part of this year. Chembio will be requesting a meeting with the FDA to confirm and further clarify the process prior to submitting an IDE.
Lawrence Siebert, CEO of Chembio Diagnostics, commented, "Today is National HIV Testing Day, and it is important to realize that the need for a simple at-home rapid HIV test is still unfulfilled. Approximately 20 percent of Americans with HIV are unaware of their infected status according to the CDC. Our test will empower individuals who don't have access to point-of-care testing, or who are afraid to take the test in a public setting, to get the information they need to make informed decisions, including getting early access to increasingly effective therapeutic treatments. We believe that our Sure Check(R) HIV system is convenient, cost effective and reliable, and that by addressing this additional market segment we will help to achieve the important public health objective of increasing awareness of HIV status."
The Sure Check(R) HIV test is a finger-stick whole blood test that is unique in how easy it is to use and provides results in just 15 minutes. This is by no means the first at-home test that uses blood samples; many diabetes and coagulation monitoring tests currently use blood samples. Chembio believes that its test will be as acceptable to the general public as these other tests that have been widely used in the home testing market.
Chembio's Sure Check(R) HIV test uses a "barrel" system that is easy to use and should be accepted for self-testing based upon its growing success in the professional market, such as public health testing clinics. The barrel system contains a sample port at one end of the barrel which houses the HIV test strip. The small blood sample (only 2.5 micro liters required) enters the barrel simply by touching the sample port to the fingertip pricked with the provided safety lancet. The "barrel" technology confines the sample and reagents, thereby minimizing potential exposure to the user or other parties. [For more information see http://www.chembio.com/humantest3.html ]
Sure Check(R) HIV received FDA approval for professional use on May 25, 2006 and was granted CLIA waiver status in 2007. The HIV 1/2 Stat-Pak(R) Assay, Chembio's other FDA-approved lateral flow rapid HIV test, also received approval for hospitals and clinics on May 25, 2006. To date, these represent two of the four FDA-approved rapid HIV tests in the U.S. market. Chembio's patented Dual Path Platform (DPP(R)) HIV test, for use with oral fluid or blood samples, is currently in clinical trials. Also in development with Chembio's DPP(R) technology are DPP(R) Syphilis, DPP(R) Hepatitis C and DPP(R) Influenza tests.
About Chembio Diagnostics
Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $7 billion point-of-care testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the U.S. by Alere, Inc., formerly known as Inverness Medical Innovations, Inc. Chembio markets its HIV STAT-PAK(R) line of rapid HIV tests internationally to government and donor-funded programs directly and through distributors. Chembio has developed a patented point-of-care test platform technology, the Dual Path Platform (DPP(R)) technology, which has significant advantages over lateral-flow technologies in numerous applications. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP(R). Headquartered in Medford, NY, with approximately 100 employees, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U. S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13.485.
Contacts:
Company Contact
Susan Norcott
631-924-1135 x125
snorcott@chembio.com
Investor & Public Relations
The Investor Relations Group
212-825-3210
James Carbonara
JCarbonara@investorrelationsgroup.com
SOURCE: Chembio Diagnostics, Inc.
http://www.marketwatch.com/story/chembio-initiates-pre-ide-studies-for-home-use-of-sure-checkr-rapid-hiv-test-2011-06-27?siteid=nbsh
Background
Chembio - StatSure - Inverness - Doc Seymour
Chembio, StatSure, Inverness sign agreements
Deal 10/1/2006
EXECUTIVE SUMMARY
StatSure Diagnostic Systems and Chembio Diagnostics have settled their litigation relating to StatSure's HIV barrel technology and have signed licensing agreements with Inverness Medical Innovations . The barrel is a collector that receives a whole blood sample directly from the fingertip, without using a transfer device, thus maximizing ease of use and minimizing exposure to infectious agents.
http://sis.windhover.com/buy/abstract.php?id=200620650&utm_source=company
Ubertino
17 years ago
StatSure Diagnostic Systems, Inc. Announces First Quarter Revenues and Management Changes
Last update: 3:14 p.m. EDT May 16, 2008
NEW YORK, May 16, 2008 (BUSINESS WIRE) -- StatSure Diagnostic Systems, Inc. (OTCBB: "SSUR") today announced its financial results for the three months ended March 31, 2008. The increase in revenue for the three months in 2008 consists of greater sales of our saliva collectors and an increase in license fees from the Company's various license agreements with ChemBio and Inverness.
Three Months Ended March 31,
2008 2007
-------- --------
Product Sales $224,370 $142,862
Royalty and Other Income 35,800 10,986
Selling, general and administrative expenses 244,579 495,604
Additionally, the Company announced that effective July 1, 2008, Mr. Steve M. Peltzman, Chairman of the Board and Chief Executive Officer, and Mr. D. Bruce Pattison, President, Chief Operating Officer and Director, have resigned. Messrs Peltzman and Pattison, have indicated that they will enter into Consulting Agreements with StatSure. In addition, Mr. Richard Woodrich has resigned as Director. Concurrently, the Board elected Mr. Moishe Bodner, currently Vice President of the Company, as Chief Executive Officer and Director, and Mr. Leo Ehrlich, the current Chief Financial Officer and Director, was elected as the President, Chief Operating Officer effective July 1, 2008.
The incoming Chief Executive Officer noted that the Company accepted the resignations of Mr. Peltzman and Mr. Pattison with regret, and thanked them for their services. As Mr. Bodner pointed out, "Their commercial leadership and expertise with respect to strategic partnering and regulatory affairs raised StatSure to a new level in consummating the transactions with Inverness and ChemBio, as well as other transactions which will allow us to increase the revenues and margins from our existing products and technology. While they have reduced their time commitments to the Company, StatSure will be able to avail itself of their knowledge and expertise as consultants to the Company."
The Company also announced that it had been granted a patent on one of its key technologies in Brazil.
About StatSure
StatSure Diagnostic Systems, Inc. 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.
Please visit our website at http://www.StatSure.com.
StatSure Diagnostic Systems, Inc.
http://www.StatSure.com
SOURCE: StatSure Diagnostic Systems, Inc.
StatSure Diagnostic Systems, Inc.
Mo Bodner, 347-394-3641
mobodner@statsure.com
Copyright Business Wire 2008
BonelessCat
17 years ago
NEWS: StatSure Awarded Patents in Japan and India
Tuesday November 27, 8:30 am ET
FRAMINGHAM, Mass., Nov. 27 /PRNewswire-FirstCall/ -- StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR - News) announced the issuance in Japan and in India of additional international patents for its diagnostic testing platform, termed the "barrel" technology. StatSure's technology is also protected by a US patent and is part of a licensed, FDA approved and CLIA waived product for HIV, currently being sold in the US and elsewhere. The barrel technology is an integrated, disposable device used to rapidly and safely collect, process and test patients in point-of care locations to screen for certain infectious diseases. Results can be read within minutes, without instrumentation and the kit may be stored without refrigeration for up to 24 months. Point-of- care markets include clinics, doctors' office, emergency rooms and many other sites where results are needed quickly and safely.
The barrel-based product requires a tiny drop (~2.5 microliters) of whole blood, serum, or plasma and eliminates the need to separately handle, collect, and dispense a physiological specimen. Typically, the tip of the barrel touches a drop of fingertip blood, and though capillary action moves the specimen to the test strip inside the barrel, thereby minimizing the possibility of technician exposure to the potentially infected blood. A buffer vial sits atop the barrel forming a full kit with no other items needed. The test comes with an internal control to confirm that the test has been done correctly.
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