Chembio Diagnostics gains CLIA waiver
This article was originally published in The Gray Sheet
Executive Summary
Firm's HIV 1/2 Stat-Pak rapid HIV test gains waiver under the Clinical Laboratory Improvement Ammendments, allowing broad-scale marketing to 189,000 U.S. physician offices and clinics. Chembio expects U.S. marketing partner Inverness Medical to launch the test in early 2007, pending FDA sign-off on labeling changes. The test was approved by FDA in May along with Chembio's Sure Check HIV 1/2 rapid test, which still awaits CLIA waiver. Orasure (OraQuick Advance) and Trinity (Uni-Gold Recombigen) currently market the only CLIA-waived rapid HIV tests. Separately, Chembio is developing a rapid syphilis test using its Dual Path Platform (DPP) technology and syphilis antigens provided by the Centers for Disease Control & Prevention under a cooperative research and development agreement announced Nov. 27. Chembio also is using the DPP technology to develop an oral fluid HIV test (1"The Gray Sheet" Oct. 9, 2006, p. 16)...