Calypte Receives Initial Order for the Middle East; Additional Orders Expected as Regulatory Approvals Received.
Business Editors/Health/Medical Writers
ALAMEDA, Calif.--(BUSINESS WIRE)--June 24, 2003
Calypte Biomedical bi·o·med·i·cal
1. Of or relating to biomedicine.
2. Of, relating to, or involving biological, medical, and physical sciences. Corporation (OTCBB OTCBB
See OTC Bulletin Board (OTCBB). :CYPT), the developer and marketer of the only two FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. approved HIV-1 antibody tests for use with urine samples, announced that it has received an initial order from Mistaire LLC (Logical Link Control) See "LANs" under data link protocol.
LLC - Logical Link Control for HIV-1 Urine EIA (Electronic Industries Alliance, Arlington, VA, www.eia.org) A membership organization founded in 1924 as the Radio Manufacturing Association. It sets standards for consumer products and electronic components. screening tests and Urine HIV-1 Western Blot Western blot
A technique developed in 1979 that is used to confirm ELISA results. HIV antigen is purified by electrophoresis and attached by blotting to a nylon or nitrocellulose filter. supplemental tests for use within the United Arab Emirates United Arab Emirates, federation of sheikhdoms (2005 est. pop. 2,563,000), c.30,000 sq mi (77,700 sq km), SE Arabia, on the Persian Gulf and the Gulf of Oman. (UAE (Uninterruptible Application Error) The name given to a crash in Windows 3.0. In subsequent versions of Windows, a crash was called a "General Protection Fault," "Application Error" or "Illegal Operation." See crash in Windows and abend. ). Calypte recently sent representatives to the UAE to undertake demonstrations and training sessions.
In April, Calypte announced its appointment of Mistaire as its exclusive distribution for the six member states of the Gulf Cooperative Council (GCC GCC: see Gulf Cooperation Council.
(compiler, programming) GCC - The GNU Compiler Collection, which currently contains front ends for C, C++, Objective-C, Fortran, Java, and Ada, as well as libraries for these languages (libstdc++, libgcj, etc). ), which include Saudi Arabia, UAE, Bahrain, Qatar, Kuwait, and Oman. Additional orders from other GCC states are anticipated as the urine HIV tests gain regulatory clearances.
"We had not been forecasting sales from this region until later in the year, and we are certainly pleased with the quick action and initiative shown by Mistaire," said Tony Cataldo, Calypte's Executive Chairman. "This early success suggests that the benefits of our painless and safer testing option should become readily available throughout the GCC in the foreseeable future."
B.J. Harid, President of Mistaire, stated, "When we took on the Calypte urine HIV tests, we did so in the belief that the potential safety hazards associated with traditional blood tests are a significant concern even in this region where the incidence of AIDS is relatively low, and that urine testing could make a meaningful contribution to improving the safety of HIV testing for all parties concerned. Our early findings support that premise, and we will be actively working to maximize the opportunity."
"The GCC market is an interesting one for us, because it shows that the benefits of urine HIV testing over traditional blood-based approaches apply equally in low-prevalence settings as they do in those regions hardest hit by the epidemic," said Richard VanMaanen, Calypte's Director of International Business Development.
About Mistaire LLC
Mistaire LLC is a U.S.-based corporation headquartered in New York City New York City: see New York, city.
New York City
City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. . Mistaire Ltd., an associated company in India, operates a manufacturing facility for biochemistry reagents and pharmaceutical products, and distributes those products in both India and the GCC. Mistaire's GCC operations are headquartered in Dubai, United Arab Emirates.
About Calypte Biomedical
Calypte Biomedical Corporation, headquartered in Alameda, California, is a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus human immunodeficiency virus
Human immunodeficiency virus (HIV)
A transmissible retrovirus that causes AIDS in humans. Type 1 (HIV-1), sexually transmitted diseases Sexually transmitted diseases
Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely and other infectious diseases. Calypte's tests include the screening EIA and supplemental Western Blot tests, the only two FDA-approved HIV-1 antibody tests that can be used on urine samples. When compared with existing blood-based tests, our testing algorithms are non-invasive, easier to use, less expensive and have significantly less risk than blood-based testing, and they have 99.7% sensitivity in subjects previously identified as HIV-1 infected and 100% specificity in subjects at low risk when combined with the urine-based Western Blot supplemental test(a). The company believes that accurate, non-invasive urine-based testing methods for HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. and other infectious diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly. Calypte markets its products in countries worldwide through international distributors and strategic partners.
(a) "The performance of testing urine samples for HIV-1 antibodies is reduced in some populations in comparison to testing blood. Please refer to the product inserts for details."
Statements in this press release 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, our ability to obtain additional financing and access funds from our existing financing arrangements that will allow us to continue our current and future operations and whether demand for our product and testing service in domestic and international markets will continue to expand. 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"), including its annual report on Form 10-K for the year ended December 31, 2002, and its subsequent filings with the SEC.