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Calypte Biomedical Corp.

FDA Compliance

Chinese State FDA Completes Technical Review of Oral HIV Test Application

Published: Tuesday, February 26, 2008 - 23:00

(Calypte Biomedical Corp: Portland, Oregon) -- Calypte Biomedical Corp., a developer, manufacturer and marketer of HIV diagnostic tests, recently announced that the Chinese State Food and Drug Administration (SFDA)—the equivalent of the U.S. FDA—has notified Calypte’s Chinese manufacturing subsidiary, Beijing Marr Bio-pharmaceutical Co. Ltd., that the technical review of its Aware HIV-1/2 OMT rapid oral test product application has been completed. Pending the SFDA’s review of conformity to product standard documents and labeling to applicable regulations, the application will progress to the concluding administrative approval.

“This is a major milestone in a long and difficult approval process,” says Roger I. Gale, Calypte’s president and CEO, “We are extremely pleased that the SFDA has determined that our scientific data has met their criteria, and that we are now moving into the final phase of the registration process. We believe that in meeting the technical standards established by the SFDA, we have demonstrated to them the high quality of our product.”

Calypte operates in China through Beijing Marr, a joint venture between Calypte and the Marr Group established to manufacture Calypte’s Aware line of rapid HIV tests, including the Aware HIV-1/2 OMT product for the Chinese and international markets.

SFDA guidelines for registration and technical review are strenuous. “The technical review is considered the most challenging and lengthy portion of the SFDA review process, and is the penultimate milestone in the approval process,” says Dr. Ronald W. Mink, Calypte’s chief science officer. “We are absolutely delighted that we have overcome what is arguably the highest hurdle in the approval process, and are ready to move into the final administrative stage.”

For more information, visit http://eng.sfda.gov.cn/cmsweb/webportal/W43879541/A64007096.html

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Calypte Biomedical Corp.