DRW HIV-Ab/HBsAg Duplex Rapid Test submission for FDA-PMA approval

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DESCRIPTION (provided by applicant): Confidential information: Patent application in process. Diagnostics for the Real World, Ltd. (DRW) aims to market a high-performance duplex rapid test (DRW HIV-Ab/HBsAg Duplex Rapid Test), called DRW HIV-HBV Duplex, which can simultaneously detect antibodies to HIV (HIV-Ab) for diagnosis of human immunodeficiency virus (HIV) infection and hepatitis B surface antigen (HBsAg) for diagnosis of hepatitis B virus (HBV) infection. The test 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 and/or HIV. This simple and inexpensive but highly sensitive duplex 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 renewal application that proposes to conduct pre-clinical and clinical studies on the DRW HIV-HBV Duplex with the ultimate aim of meeting the requirements for pre- market approval (PMA) by the Food and Drug Administration (FDA). Pre-clinical studies to evaluate test performance for HBsAg detection will be based on FDA's 1) "Review criteria for assessment of HBeAg and antibody to HBeAg in vitro diagnostic devices" (FDA 1991) for the performance evaluation on HBsAg detection; and 2) "Guidance for Industry-Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes" (FDA 2007). For evaluating the test performance on HIV-Ab detection, we will follow FDA's draft guidance of "Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies" (FDA 1989). 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 development of DRW HIV-HBV Duplex to proceed to clinical studies. The clinical studies aimed at a PMA submission to the FDA will be carried out at four sites in the U.S. and one site in Italy. Because of the usefulness of the DRW HIV-HBV Duplex for pre- and post-donation screening in resource-limited settings, additional evaluations will be conducted in China and Guinea. FDA approval of the DRW HIV-HBV Duplex will allow the use of a new and useful diagnostic test 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. Confidential information: patent application in process Principal Investigator: Lee, Helen H Confidential information: patent application in process PUBLIC HEALTH RELEVANCE: Clinical studies of the DRW HIV-HBV Duplex Rapid Test will make FDA approval possible, and hence availability of the test to the US market, where it will be useful in settings where a rapid and immediate test result is needed, such as emergency rooms, in the battlefield, or for healthcare workers immediately after needle stick injury. The test will also be useful in developing countries where ensuring the safety of the blood supply requires the availability of cheap, effective assays that do not rely on sophisticated equipment. This is especially true in blood banks processing less than10,000 donations/year located in regions of high prevalence for the HIV and HBV viral markers. Confidential information: patent application in process