Calypte's Aware(TM) HIV-1/2 OMT Approved as China's Only Rapid Oral HIV Test

Thu Apr 17, 2008 8:00am EDT

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Approval Enables Manufacturing, Marketing, Distribution and Sales
                           throughout China

  Company to Hold Conference Call at 10:30 a.m. EDT Today to Discuss
PORTLAND, Ore.--(Business Wire)--
Calypte Biomedical Corporation (OTCBB:CBMC), a developer,
manufacturer and marketer of HIV diagnostic tests, announced today
that its Chinese subsidiary, Beijing Marr Bio-Pharmaceutical Co. Ltd.
("Beijing Marr"), has received registration and marketing approval for
Calypte's Aware(TM) HIV-1/2 OMT (oral fluid) rapid test from the State
Food and Drug Administration ("SFDA") of China. This approval makes
the Aware(TM) HIV-1/2 OMT test the first and only SFDA approved rapid
oral fluid HIV test in China.

   Roger Gale, Calypte's Chairman and Chief Executive Officer,
stated, "This is a major accomplishment for Calypte and we are
thrilled to have received this long awaited approval which permits us
to begin actively marketing our rapid diagnostic tests in China, one
of the potentially largest HIV testing markets in the world. With the
medical devices manufacturing permit received earlier this year, our
Beijing Marr subsidiary is now able to manufacture, market, distribute
and sell the Aware(TM) HIV-1/2 OMT test throughout the Peoples'
Republic of China. China is committed to aggressively tackle the
spread of its HIV epidemic and we believe that our Aware(TM) HIV-1/2
OMT (oral fluid) test can and will make a significant contribution to
that effort. We appreciate the patience of those investors who have
supported us through the long SFDA approval process, particularly our
joint venture partners, the Marr Group." Mr. Gale added, "This
approval also gives us, for the first time, a very valuable approval
in the country of manufacture. Absence of this approval in the past
has hampered our ability to register and market the test in a number
of countries, a hurdle we can now overcome by producing the
domestically approved Aware(TM) product in our Chinese factory. With
this SFDA approval, we are now in a position to market and sell in
countries representing a total population of nearly 3.7 billion, or
over half of the worlds' population."

   Dr. Ronald Mink, Chief Science Officer for Calypte, remarked,
"This approval has validated our perseverance in pursuing the
registration of a product in which we have long had confidence. The
transformation of the SFDA over the past two to three years into a
first tier agency matching the rigor and integrity of its U.S. and
European counterparts resulted in a very thorough review of the
Aware(TM) HIV-1/2 OMT (oral fluid) test. We believe that the Chinese
authorities are now comfortable with this new technology, which
expands the scope of testing platforms currently available in China.
The SFDA's restructuring has resulted in a review process and
timetable that is similar to what we see in the U.S. FDA. We believe
these changes will benefit not only China, by setting a higher
standard for new medical products, but will also benefit us, by
setting a higher barrier to market entry for would-be competitors.
Throughout the entire review process, we received continually positive
feedback from the SFDA and we have been confident that our technology
is solid and our registration would prevail."

   David Harris, Beijing Marr's Chief Executive Officer, stated,
"This is a very exciting moment for those of us at Beijing Marr who
have worked very hard to gain this approval and ready the factory for
manufacture, sale and distribution of the Aware(TM) HIV-1/2 OMT test.
We have already received numerous inquiries from HIV program managers
and scientists eager to use the product here in China. We now plan to
ramp up our production capacity as we build our distribution network
to fully realize the market potential of the Aware(TM) HIV-1/2 OMT
test in China. Beijing Marr is committed to, and enthusiastic about,
bringing this exciting new technology to the Chinese medical

   Calypte operates in China through Beijing Marr, a joint venture
between Calypte and the Marr Group 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.
Beijing Marr operates an ISO 13485:2003 certified manufacturing
facility on the outskirts of Beijing. 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 approved blood based laboratory HIV EIA tests.

   Conference Call:

   Calypte will host a conference call today at 10:30 a.m. EDT. The
call can be accessed in the U.S. by dialing 866-510-0707 and outside
of the U.S. by dialing 617-597-5376. The participant pass code is
49798845. The conference call will also be webcast live at An audio replay of the call will be available through
May 18, 2008, beginning approximately 1 hour after the conference call
ends, by dialing 888-286-8010 in the U.S., or 617-801-6888 from
outside of the U.S. The pass code for the playback is 64031187. The
web cast will also be available for replay on Calypte's website.

   About Calypte Biomedical:

   Calypte Biomedical Corporation ( 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. 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

   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.

   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-K for the year ended December 31, 2007 and its subsequent filings
with the SEC.

Calypte Biomedical Corporation
Jerrold D. Dotson, 503-726-2227
CEOcast, Inc.
Investor Relations
Dan Schustack, 212-732-4300

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