Calypte Biomedical Reports On US Conference on AIDS
THURSDAY, SEPTEMBER 26, 2002 3:13 PM
- PR Newswire
ALAMEDA, Calif., Sep 26, 2002 /PRNewswire-FirstCall via COMTEX/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CALY), the developer and marketer of the only two FDA approved HIV-1 antibody tests for use with urine samples, shared information about the benefits and performance of its urine HIV-1 tests at the United States Conference on AIDS (USCA) held last week in Anaheim, CA.
"At the USCA, Calypte showcased the results of the feasibility testing for the Rapid HIV Urine Test, and we experienced a similar positive reception as at the World Conference on AIDS in Barcelona," stated Nancy Katz, president and CEO of Calypte Biomedical. "Several community organizations expressed their desire to participate in future clinical studies for the Rapid Test. The genuine excitement expressed by these healthcare professionals provides further support for Calypte's decision to accelerate the development of the Rapid Test."
"This conference proved to be an excellent opportunity for Calypte to further build awareness in the public health arena about the advantages of urine testing. We were very encouraged to observe that more people we spoke to this year were familiar with urine testing, and were very intrigued by the option of screening for both HIV and sexually transmitted diseases with the same specimen," concluded Katz.
The company has scheduled a pre-IDE (Investigational Device Exemption) meeting with the Food and Drug Administration (FDA) for October 4th, to define and agree to clinical testing plans and requirements to evaluate the rapid test for the detection of HIV-1 antibodies in urine. Calypte's Rapid Urine Test is intended to combine the advantages of the current generation of rapid blood HIV tests, including simplicity of use and speed of results, with the benefits of currently approved urine tests. While the performance characteristics of this product have not been established, preliminary results of an internally conducted study for the rapid urine HIV-1 test have yielded 100% sensitivity and 100% specificity."
The USCA is the largest gathering of HIV/AIDS service providers in the country and was attended by more than 3,500 key decision-makers and front-line service providers
THURSDAY, SEPTEMBER 26, 2002 3:13 PM
- PR Newswire
ALAMEDA, Calif., Sep 26, 2002 /PRNewswire-FirstCall via COMTEX/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CALY), the developer and marketer of the only two FDA approved HIV-1 antibody tests for use with urine samples, shared information about the benefits and performance of its urine HIV-1 tests at the United States Conference on AIDS (USCA) held last week in Anaheim, CA.
"At the USCA, Calypte showcased the results of the feasibility testing for the Rapid HIV Urine Test, and we experienced a similar positive reception as at the World Conference on AIDS in Barcelona," stated Nancy Katz, president and CEO of Calypte Biomedical. "Several community organizations expressed their desire to participate in future clinical studies for the Rapid Test. The genuine excitement expressed by these healthcare professionals provides further support for Calypte's decision to accelerate the development of the Rapid Test."
"This conference proved to be an excellent opportunity for Calypte to further build awareness in the public health arena about the advantages of urine testing. We were very encouraged to observe that more people we spoke to this year were familiar with urine testing, and were very intrigued by the option of screening for both HIV and sexually transmitted diseases with the same specimen," concluded Katz.
The company has scheduled a pre-IDE (Investigational Device Exemption) meeting with the Food and Drug Administration (FDA) for October 4th, to define and agree to clinical testing plans and requirements to evaluate the rapid test for the detection of HIV-1 antibodies in urine. Calypte's Rapid Urine Test is intended to combine the advantages of the current generation of rapid blood HIV tests, including simplicity of use and speed of results, with the benefits of currently approved urine tests. While the performance characteristics of this product have not been established, preliminary results of an internally conducted study for the rapid urine HIV-1 test have yielded 100% sensitivity and 100% specificity."
The USCA is the largest gathering of HIV/AIDS service providers in the country and was attended by more than 3,500 key decision-makers and front-line service providers
