Calypte's Aware(R) HIV-1/2 OMT Oral Fluid Rapid Test Approved in USAID Waiver List
Approval Opens $15 Billion PEPFAR Markets; Company To Hold Conference Call at 10:30 am Eastern time today
PORTLAND, Ore.--(BUSINESS WIRE)--
Calypte Biomedical Corporation (OTCBB: CBMC), a manufacturer of medical diagnostic tests for the rapid detection of antibodies to the human immunodeficiency virus (HIV), announced today that its Aware(R) HIV-1/2 OMT oral fluid rapid test has been approved by the U.S. Agency for International Development ("USAID"). The Aware(R) product has been placed on the USAID rapid HIV test waiver list, which under the U.S. Acquisition & Assistance Policy Directive (AAPD 05-01) permits use of the Aware(R) test in USAID-funded projects. The inclusion now permits countries such as South Africa, Kenya and Uganda, where the Company's HIV Test is approved, to purchase Aware(R) using funding from the President's Emergency Plan for AIDS Relief ("PEPFAR"), which was first announced in 2003 and subsequently reaffirmed and increased this past January when President George W. Bush asked Congress to commit $15 billion over the next five years, including nearly $10 billion in new money, to combat AIDS. PEPFAR is the largest commitment ever by any nation for an international health initiative dedicated to a single disease.
The evaluation was directed, reviewed and approved by the U.S. Centers for Disease Control and Prevention (the "CDC") which has the responsibility for evaluation of all rapid HIV tests for the USAID. The CDC determined that our test satisfied the USAID requirements and recommended its inclusion in the list of products available for purchase by countries receiving USAID funds. USAID has added the kit to its latest update of the waiver list - (http://www.usaid.gov/ our_work/global_health/aids/TechAreas/scms/scms.html). (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)
Roger I. Gale, Chairman and Chief Executive Officer of Calypte noted, "This represents a major breakthrough for us on two fronts. First, our oral fluid test, now eligible to be purchased by USAID, has gained access to the biggest single source of purchasing power for rapid HIV tests in the world. And, as we continue to gain additional country approvals, our market opportunities will expand even further. Second, by matching the results of the other rapid blood tests in the CDC evaluation, the results validated what we have always known. Specifically, this rapid oral fluid test is a highly accurate, efficacious test which holds its own against what are considered some of the best rapid blood tests in the world. The performance of our product, together with the safety, simplicity and ease-of-use features and USAID approval will, we believe, drive sales in countries where our test can now be acquired with PEPFAR funds. We believe this validation also adds credibility in the private sector, and in fact we have already received strong interest from potential new customers in South Africa in anticipation of this approval and expect increased sales as a direct result of this approval."
Dr. Ronald Mink, Calypte's Chief Science Officer expanded, "By meeting the stringent USAID criteria for addition to their waiver list, Aware(R) HIV-1/2 OMT again demonstrates accuracy equal to what many consider the best of the rapid blood-based rapid tests available. One component of the current study compared the results of testing oral fluid and blood collected from the same subjects at the same clinic visit. Oral fluid was tested by the Aware(R) HIV-1/2 OMT Rapid Test and blood by Determine(TM) HIV-1/2, the most widely used rapid HIV test in the world and Uni-Gold(TM) HIV, a test approved by the U.S. FDA. In this study, all subjects who tested positive by Aware(R) HIV-1/2 OMT had their blood tested by both Determine(TM) HIV-1/2 and Uni-Gold(TM) HIV. For all of these subjects, the results from all three tests were concordant. Subjects who tested negative by Aware(R) HIV-1/2 OMT had their blood tested by Determine(TM) HIV-1/2. Again, the results of Aware(R) with this blood testing were 100% concordant."
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