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To Buy or not to buy? This says it all
by: rapid_test_rewards (41/M/Dallas, TX)
Long-Term Sentiment: Strong Buy 12/15/04 12:00 pm
Msg: 1105 of 1567
Calypte Biomedical Initiates China Clinical Trials of Rapid Test Platform
Wednesday December 1, 9:32 am ET
PLEASANTON, Calif., Dec. 1 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV - News) today announced that it has initiated a clinical trial program of its rapid HIV-1/2 test platform and HIV-1 Western blot supplemental tests in The Peoples Republic of China (China). The trial will evaluate the sensitivity and specificity of the Company's three rapid HIV 1/2 antibody tests: blood, oral fluid and urine. The trial will also evaluate the Company's HIV-1 Western Blot supplemental tests in blood and urine.
Dr. Richard George, President and CEO of Calypte said, "The initiation of the Chinese clinical trial program represents an important milestone in the development of our rapid test platform. We are testing approximately 1,500 patients and expect to complete the data collection by the end of this year."
The clinical trial program in China will evaluate the subjects using no less than 7 locations that will perform the rapid HIV 1/2 tests and using at least 3 laboratories that will perform the HIV-1 Western Blot supplemental tests. The trial is expected to take four to six weeks to enroll the desired 1,500 subjects. The Company expects a full statistical analysis to be available approximately two weeks after the last patient has been enrolled.
Dr. George continued, "In accordance with company policy, we will not provide interim data on assay performance in this clinical trial. However, we will release the performance results when the trials have been completed and certified by our Chinese contractor. Our objective is to file the required regulatory applications with the Chinese FDA (SFDA) in early 2005. Based on our understanding of the current Chinese regulatory submission process, we expect to receive a response from SFDA by approximately mid-2005. We also expect to have production from our manufacturing plant available by that time to support the launch into China, contingent upon regulatory approval, in the second half of 2005. We expect to have an initial production capacity of over 30 million tests per year for the Chinese market."
There are a reported 840,000 adults and children in China living with HIV/AIDS today, and according to the Bill & Melinda Gates Foundation, China is one of the "next wave" countries where the number of infections is expected to grow to 15 million by 2010. China has recognized this problem and acknowledged its testing gap. The annual AIDS testing level is currently estimated at 1.5% of the population. The Chinese government has recently announced its commitment to offer voluntary HIV testing to its entire 1.36 billion-population. Calypte believes that the only effective way to manage such numbers is to utilize trained non-professionals who would be able to execute such a program based on safe, alternative fluid testing -- oral fluid or urine -- HIV 1/2 tests. There are other focused and large markets within China where testing is mandated, such as population control, prisons and immigration.
by: rapid_test_rewards (41/M/Dallas, TX)
Long-Term Sentiment: Strong Buy 12/15/04 12:00 pm
Msg: 1105 of 1567
Calypte Biomedical Initiates China Clinical Trials of Rapid Test Platform
Wednesday December 1, 9:32 am ET
PLEASANTON, Calif., Dec. 1 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV - News) today announced that it has initiated a clinical trial program of its rapid HIV-1/2 test platform and HIV-1 Western blot supplemental tests in The Peoples Republic of China (China). The trial will evaluate the sensitivity and specificity of the Company's three rapid HIV 1/2 antibody tests: blood, oral fluid and urine. The trial will also evaluate the Company's HIV-1 Western Blot supplemental tests in blood and urine.
Dr. Richard George, President and CEO of Calypte said, "The initiation of the Chinese clinical trial program represents an important milestone in the development of our rapid test platform. We are testing approximately 1,500 patients and expect to complete the data collection by the end of this year."
The clinical trial program in China will evaluate the subjects using no less than 7 locations that will perform the rapid HIV 1/2 tests and using at least 3 laboratories that will perform the HIV-1 Western Blot supplemental tests. The trial is expected to take four to six weeks to enroll the desired 1,500 subjects. The Company expects a full statistical analysis to be available approximately two weeks after the last patient has been enrolled.
Dr. George continued, "In accordance with company policy, we will not provide interim data on assay performance in this clinical trial. However, we will release the performance results when the trials have been completed and certified by our Chinese contractor. Our objective is to file the required regulatory applications with the Chinese FDA (SFDA) in early 2005. Based on our understanding of the current Chinese regulatory submission process, we expect to receive a response from SFDA by approximately mid-2005. We also expect to have production from our manufacturing plant available by that time to support the launch into China, contingent upon regulatory approval, in the second half of 2005. We expect to have an initial production capacity of over 30 million tests per year for the Chinese market."
There are a reported 840,000 adults and children in China living with HIV/AIDS today, and according to the Bill & Melinda Gates Foundation, China is one of the "next wave" countries where the number of infections is expected to grow to 15 million by 2010. China has recognized this problem and acknowledged its testing gap. The annual AIDS testing level is currently estimated at 1.5% of the population. The Chinese government has recently announced its commitment to offer voluntary HIV testing to its entire 1.36 billion-population. Calypte believes that the only effective way to manage such numbers is to utilize trained non-professionals who would be able to execute such a program based on safe, alternative fluid testing -- oral fluid or urine -- HIV 1/2 tests. There are other focused and large markets within China where testing is mandated, such as population control, prisons and immigration.
