MEDFORD, N.Y. -- Chembio Diagnostics Inc. has made substantial progress toward the launch of its PrimaTB STAT-PAK(TM) rapid test and plans commercial release of the test in late 2006, pending completion of the external reproducibility studies and USDA facility inspection and licensure.

The test is for simple and rapid detection of tuberculosis (TB) in non-human primates (NHP). TB in both captive and wild animals is a significant problem in the US, Europe and Japan, and more effective diagnostic tools are needed.



Economic costs range from loss of whole NHP colonies used in research to loss of TB-free status amongst cattle herds, potentially halting dairy and meat processing activities. Currently available veterinary TB diagnostic tests are inaccurate, cumbersome and time-consuming to perform and to obtain results.



In addition to its PrimaTB STAT-PAK, Chembio is completing a series of veterinary TB rapid tests for other animals such as cattle, deer, camels, elephants and other exotic species.



The veterinary TB product was recently awarded U.S. Animal Health Association recommendation for conditional approval for use in bovids, cervids, elephants and other exotic animals. Pending completion of clinical trials and receipt of USDA licensure, these various VetTB STAT-PAK assays are currently planned for commercial release in early 2007.



These tests are all based on the detection of TB antibodies from whole blood (as well as serum or plasma) reacting to a cocktail of carefully selected recombinant TB antigens and offer a number of advantages over current standard skin testing. These include ease of use, portability, rapid results (in less than 20 minutes), minimal invasiveness, better sensitivity and specificity, and anticipated lower associated labor costs.



These features in PrimaTB STAT-PAK will benefit pharmaceutical companies, clinical research organizations, and large primate suppliers and national primate research centers.



Chembio Diagnostics Inc. develops and manufactures rapid diagnostic tests for various infectious diseases.



SOURCE: Chembio Diagnostics Inc. via Business Wire.