Chembio Diagnostics reported that the US Agency for International Development (USAID) has cleared its DPP® (Dual Path platform) Oral HIV 1&2 Screen Assay for inclusion on the list of approved rapid HIV tests. Chembio says that USAID approval means the point-of-care test is now eligible for procurement with funds provided by The United States President’s Emergency Plan for AIDS Relief (PEPFAR).
The firm also confirmed that it has started U.S. clinical trials relating to a future Pre-Market Approval (PMA) application for the product. Completion of the studies is expected during 2010, and PMA by FDA is anticipated in 2011. Future development of the test as an over-the-counter diagnostic is also on the cards. In the meantime, Chembio is registering and establishing distribution for the DPP oral fluid HIV test in various markets.
The assay is designed for use with oral fluid or blood samples. According to Chembio, recent field studies including a CDC Global AIDS Program (CDC-GAP) trial found the assay to be more accurate than some other rapid HIV tests used widely by PEPFAR. In one CDC-GAP study in Mozambique, the DPP oral fluid assay demonstrated 100% sensitivity and 99.8% specificity. This exceeded the performance of the other three tests evaluated, Chembio points out. Similarly, an international trial in Nigeria sponsored by the company found the assay performed with 100% sensitivity and 100% specificity.
The DPP Oral HIV 1&2 Screen Assay is based on Chembio’s Dual Path Platform rapid diagnostic technology. The system utilizes a patent-pending oral fluid collection system for the preparation and storage of the sample solution prior to being applied to the test strip. The technology allows samples to be incubated with capture reagents on a test strip before introduction of the labeling reagent, which the firm claims allows a more sensitive binding reaction to take place. The collection system also allows users to store samples for extended periods before testing, and/or retain samples for further testing.
Chembio is also exploiting the DPP platform for the development of a point-of-care diagnostic for syphillis, which the firm anticipates could achieve regulatory clearance in 2011. Prototypes of an oral fluid test for hepatitis C and various strains of influenza have also been developed, the company adds.
Chembio’s existing FDA-approved HIV tests are based on lateral flow technology. The two tests are marketed exclusively in the U.S. by Inverness Medical Innovations under the Clearview® brand as HIV 1/2 STAT-PAK® and COMPLETE HIV 1/2.