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China approves Calypte's Aware oral rapid HIV test
By E. Janene Geiss
Philadelphia, Jan. 12 - Calypte Biomedical Corp. said it has received notification from the Beijing Drug Administration that its application for approval in China of its Aware OMT (oral) HIV-½ rapid test has been formally accepted.
The company submitted its application to the BDA on Dec. 27, according to a company news release.
According to Chinese drug registration regulations, the BDA is responsible for receiving applications on behalf of the State Food and Drug Administration of China.
Formal acceptance means the BDA has completed an initial review of the application and deems the application to be sufficiently complete and in compliance with regulations to allow the application to advance into the formal review process.
"China is one of the countries that may experience a significant spread of HIV unless the government can follow through on its plans to curtail the growth of this problem. China has an acknowledged testing gap and has officially announced plans to offer voluntary HIV testing to its entire 1.36 billion population, with particular emphasis on certain key groups, for which we believe our test is particularly appropriate," Roger Gale, chairman and chief executive officer of Calypte, said in the release.
According to a joint China, World Health Organization and UNAIDS epidemiological survey there were a reported 840,000 adults and children in China living with HIV/AIDS in 2003.
Calypte Biomedical is a Lake Oswego, Ore., health care company focused on the development and commercialization of diagnostic testing products for the detection of sexually transmitted diseases.
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