Calypte's Chinese Manufacturing Subsidiary Obtains ISO 13485:2003 Certification of Quality Management System

Business Wire, Dec 6, 2007

PORTLAND, Ore. -- Calypte Biomedical Corporation (OTCBB: CBMC), a developer, manufacturer and marketer of HIV diagnostic tests, announced today that its Beijing China manufacturing subsidiary, Beijing Marr Bio-pharmaceutical Co., Ltd., Beijing China, a joint venture between Calypte and a Marr Group subsidiary ("Marr") has successfully passed its quality system audit and obtained certification of its quality system to the international standard, ISO 13485:2003. Certification was provided by TUV SUD Management Service GmbH of Munich Germany.

The ISO 13485:2003 standard specifically addresses the application of quality system principles to medical device products and is based on the ISO 9001:2000 quality management standard with many requirements specific to the medical device industry. Regulatory authorities in several countries around the world such as US FDA, Health Canada, China, the European Union and elsewhere base their requirements for good manufacturing practices (GMP) on the ISO quality standards. Conformance to the ISO standards is one of the many requirements for compliance with the European Union Medical Device and In Vitro Diagnostics Directives and obtaining CE Marking.

Beijing Marr Bio-pharmaceutical Co. was established by Calypte and its joint venture partner, Marr, to manufacture its 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 that uses oral fluid for a diagnosis of HIV-1 or 2 infection in as little as 20 minutes with an accuracy comparable to U.S. FDA approved blood based laboratory HIV EIA tests. Beijing Marr Bio-pharmaceutical Co. is currently manufacturing the Aware[TM] HIV-1/2 OMT product for export from China and this certification expands the number of countries to which the facility can export product. Beijing Marr Bio-pharmaceutical Co. is awaiting approval from the China State Food and Drug Administration (SFDA) to distribute and sell the product within China.

Roger I. Gale, Calypte's President and Chief Executive Officer, explained, "This is the first ISO quality system certification of our China manufacturing facility and we are very pleased that TUV SUD has granted Beijing Marr's quality management system certification to ISO 13485. This internationally recognized certification affirms Beijing Marr's GMP system and complements our recent USAID approval of the Aware[TM] HIV-1/2 OMT rapid test, documenting the product's excellent performance characteristics. Together, we believe, this clearly documents Calypte's company-wide commitment to quality products and we are excited that the international community continues to recognize our quality commitment to our customers. In addition, this certification should facilitate our product registration process in many countries and with international regulatory bodies that require a third party certification of a GMP and quality management system before product approval can be issued."

David K. Harris, Chief Executive Officer of Beijing Marr Bio-pharmaceutical Co., Ltd. stated, "We are very happy to have received this certification from TUV SUD, which recognizes the commitment we have made to providing quality products and helps us pave the way not only for gaining access to additional international markets, but which we believe will facilitate the SFDA's approval of Beijing Marr's quality system in conjunction with our pending application for the Aware[TM] HIV-1/2 OMT rapid test."

About The Marr Group:

The Marr Group is a private group of companies controlled by the Safin family. Marat Safin, a London School of Economics graduate, is the President of the Group. The Group has a large and diverse number of investments and projects globally, principally in Europe, the Far East, the Middle East and the CIS.

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 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.