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Calypte's Chinese Manufacturing Subsidiary Obtains Medical Device Manufacturing Permit.


PORTLAND, Ore. -- Calypte Biomedical bi·o·med·i·cal
adj.
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).
: CBMC CBMC Confédération des Brasseurs du Marché Commun (French: Confederation of Common Market Brewers)
CBMC Community Bank of Marion County (Florida) 
), a developer, manufacturer and marketer of 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.  diagnostic tests, announced today that its Chinese manufacturing subsidiary, Beijing Marr Bio-pharmaceutical Co., Ltd., ("Beijing Marr"), has received a permit to manufacture medical devices issued by the Beijing branch of the Chinese Food and Drug and Administration. The manufacturing permit enables the facility to manufacture in vitro diagnostic tests for the domestic Chinese market once specific product approval is received. The permit is required before Beijing Marr can sell an approved product within the country. Beijing Marr is currently awaiting approval from the China State Food and Drug Administration The State Food and Drug Administration (SFDA Simplified Chinese: 国家食品药品监督管理局) is founded on the basis of the State Drug Administration.  (SFDA SFDA State Food and Drug Administration (China)
SFDA Saudi Food & Drug Authority
) to distribute and sell Calypte's Aware[TM] HIV-1/2 OMT (Object Modeling Technique) An object-oriented analysis and design method developed by James Rumbaugh. See Rational Rose.

OMT - Object Modelling Technique
 rapid diagnostic test within China.

Beijing Marr, a joint venture between Calypte and a Marr Group subsidiary was established to manufacture Calypte's Aware[TM] line of rapid HIV tests, including the Aware[TM] HIV-1/2 OMT product for both the Chinese and international markets. The Aware[TM] HIV-1/2 OMT product is a rapid test using oral fluid to diagnose HIV-1 or HIV-2 infection in as little as 20 minutes with an accuracy comparable to that of U.S. FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approved blood based laboratory HIV 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.  tests.

Roger I. Gale, Calypte's President and Chief Executive Officer, commented, "Coming on the heels of the recent ISO (1) See ISO speed.

(2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI.
 13485 Certification of Beijing Marr's manufacturing facility, this permit is another significant milestone that brings us much closer to our objective of manufacturing and marketing our rapid test product for the Chinese market."

David K. Harris, Chief Executive Officer of Beijing Marr stated, "This permit is required because the State Food and Drug Administration moved regulatory oversight for HIV tests from the Drug Division to the Medical Device Division. Our team has been working diligently to obtain this permit to ensure that we will be permitted to manufacture our Aware(TM) HIV-1/2 OMT test once it has been approved for sale in China."

About The Marr Group:

The Marr Group is a private group of companies having a large and diverse number of investments and projects globally, principally in Europe, the Far East, the Middle East and the CIS Cis (sĭs), same as Kish (1.)


(1) (CompuServe Information Service) See CompuServe.

(2) (Card Information S
.

About Calypte Biomedical:

Calypte Biomedical Corporation (www.calypte.com) is a U.S.-based healthcare company focused on the development and commercialization of rapid testing products for 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
 such as the Aware[TM] HIV-1/2 OMT test that are suitable for use at the point of care and at home. Calypte believes there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in developing countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that testing for HIV and other sexually transmitted infectious diseases may make important contributions to public health, and could increase the likelihood of treating those with undetected HIV and other sexually transmitted diseases.

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, the Company's ability to obtain additional financing, if and as needed, and access funds from its existing financing arrangements that will allow it to continue its current and future operations and whether demand for its test products in domestic and international markets will generate sufficient revenues to achieve positive cash flow and profitability. 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-KSB for the year ended December 31, 2006 and its subsequent filings with the SEC.
COPYRIGHT 2008 Business Wire
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Publication:Business Wire
Date:Jan 10, 2008
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