Preclinical and clinical studies of an HBV rapid test for FDA Pre-market approval

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DESCRIPTION (provided by applicant): Diagnostics for the Real World, Ltd. (DRW) aims to market a high-performance rapid test for hepatitis B virus (DRW HBsAg Rapid Test) that will be useful as a diagnostic test in the United States and Europe, and as a pre- and post-donation screening test in blood banks in developing countries especially those that process less than 10,000 donations per year and are located in regions of high prevalence for HBV. This simple and inexpensive but highly sensitive rapid test was developed by DRW with funding from the Small Business Innovation Research (SBIR) program of the National Institutes of Health (NIH). The project is a competing continuation application that proposes to conduct pre-clinical and clinical studies on the DRW HBsAg rapid test, with the ultimate aim of meeting the requirements for pre-market approval (PMA) by the Food and Drug Administration (FDA). The pre-clinical studies will be based on FDA's "Review criteria for assessment of HBeAg and antibody to HBeAg in vitro diagnostic devices". Results of the pre-clinical studies will be presented to the FDA for an Investigational Device Exemption (IDE) application that, when approved, will allow the DRW HBsAg Rapid Test to be used in clinical studies. The clinical studies aimed at a PMA submission to the FDA will be carried out at two sites in the U.S. and one site in Italy. Because of the usefulness of the DRW HBsAg rapid test for pre- and post-donation screening in resource-limited settings, additional evaluations will be conducted in India, China, Guinea and Italy. FDA approval of the DRW HBsAg Rapid Test will not only pave the way for commercialization of the product in the U.S., but will also demonstrate the principle that tests used in developing countries should be of the same high quality as those used in developed countries