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OSUR » Topics » The Unavailability of Certain Products Distributed by a Third Party Could Adversely Affect Sales of Our OraSure ® Oral Fluid Collection Device.These excerpts taken from the OSUR 10-K filed Mar 10, 2009. The Unavailability of Certain Products Distributed by a Third Party Could Adversely Affect Sales of Our OraSure® Oral Fluid Collection Device. In testing an oral fluid sample collected with an OraSure® device for HIV-1 in the United States, our customers must use an HIV-1 EIA screening test approved by the FDA for use with our OraSure® device. Where an oral fluid sample screens positive for HIV-1, our customers must then use our oral fluid Western blot HIV-1 confirmatory test, which has also been approved by the FDA for use with our OraSure® device, to confirm that positive indication. Historically, BMX manufactured and sold the only oral fluid HIV-1 EIA screening test that has received FDA approval for use in detecting HIV-1 in an oral fluid specimen collected with our OraSure® collection device. BMX also supplied the HIV-1 antigen used to manufacture our oral fluid Western blot HIV-1 confirmatory test and was the exclusive world-wide distributor of that product. BMX discontinued manufacturing the HIV-1 EIA screening test in 2007. As a result, we will be conducting clinical trials and intend to seek FDA approval of an alternative HIV-1 EIA screening test manufactured by a third party for use with oral fluid samples collected with our OraSure® device. If at some point in the future our customers cannot obtain either an HIV-1 EIA screening test or a Western blot or other HIV-1 confirmatory test that has been approved by the FDA for use with our OraSure® collection device, sales of our OraSure® device could be negatively affected. The Unavailability of Certain Products oral fluid sample screens positive for HIV-1, our customers must then use our oral fluid Western blot HIV-1 confirmatory test, which has also been approved by the FDA for use with our OraSure® device, to confirm that positive indication. Historically, BMX manufactured conducting clinical trials and intend to seek FDA approval of an alternative HIV-1 EIA screening test manufactured by a third party for use with oral fluid samples collected with our OraSureSIZE="1">® device. If at some point in the future our These excerpts taken from the OSUR 10-K filed Mar 12, 2008. The Unavailability of Certain Products Distributed by a Third Party Could Adversely Affect Sales of Our OraSure® Oral Fluid Collection Device. In testing an oral fluid sample collected with an OraSure® device for HIV-1 in the United States, our customers must use an HIV-1 EIA screening test approved by the FDA for use with our OraSure® device. Where an oral fluid sample screens positive for HIV-1, our customers must then use our oral fluid Western blot HIV-1 confirmatory test, which has also been approved by the FDA for use with our OraSure® device, to confirm that positive indication. Historically, BMX manufactured and sold the only oral fluid HIV-1 EIA screening test that has received FDA approval for use in detecting HIV-1 in an oral fluid specimen collected with our OraSure® collection device. BMX also supplied the HIV-1 antigen used to manufacture our oral fluid Western blot HIV-1 confirmatory test and was the exclusive world-wide distributor of that product.
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Table of ContentsBMX discontinued manufacturing the HIV-1 EIA screening test in 2007. As a result, we intend to seek FDA approval of an alternative HIV-1 EIA screening test for use with oral fluid samples collected with our OraSure® device. On December 31, 2007, the agreements under which BMX supplies the HIV-1 antigen used to manufacture our oral fluid Western blot HIV-1 confirmatory test and distributed that product on an exclusive, world-wide basis, terminated. As a result, we are now supplying this confirmatory test directly to our laboratory customers. Pursuant to the terms of the antigen supply agreement with BMX, we purchased an additional two-year supply of the antigen from BMX so that we can continue to manufacture and sell our oral fluid Western blot test. When this additional two-year supply is combined with our existing inventory of the HIV-1 antigen, we believe we have a sufficient supply of HIV-1 antigen to meet the demand for our Western blot test for the next three to four years. If at some point in the future our customers cannot obtain either an HIV-1 EIA screening test or a Western blot or other HIV-1 confirmatory test that has been approved by the FDA for use with our OraSure® collection device, sales of our OraSure® device could be negatively affected. The Unavailability of Certain Products Distributed by a Third Party oral fluid sample screens positive for HIV-1, our customers must then use our oral fluid Western blot HIV-1 confirmatory test, which has also been approved by the FDA for use with our OraSure® device, to confirm that positive indication. Historically, BMX manufactured 24 Table of ContentsBMX discontinued manufacturing the HIV-1 EIA On December 31, 2007, the agreements under which BMX supplies the HIV-1 antigen used to manufacture our oral fluid Western blot HIV-1 Western blot or other HIV-1 confirmatory test that has been approved by the FDA for use with our OraSure® collection device, sales of our OraSure® device could be negatively affected. | EXCERPTS ON THIS PAGE:
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