OraSure Technologies, Inc., the market leader in oral fluid diagnostics, announced that it has received U.S. Food and Drug Administration (FDA) approval of its OraQuick Rapid HIV Antibody Test for use with oral fluid -- making the test the first and only rapid HIV test to be approved in the U.S. by the FDA for use with oral fluid. The test was also approved for use on plasma samples.
The approval was announced by Secretary of Health and Human Services Tommy G. Thompson and officials from the FDA and Centers for Disease Control and Prevention (CDC) at a press conference in Washington, D.C.
"This oral test provides another important option for people who might be afraid of a blood test," said HHS Secretary Tommy G. Thompson. "It will improve care for these people and improve the public health as well."
Secretary Thompson's sentiments were echoed by leaders both at home and abroad.
"The FDA's approval of additional claims for OraSure's new HIV test is a giant step forward in combating the global AIDS crisis. This simple test, which can use an oral fluid sample as opposed to a painful blood draw, gives new hope to those at risk of this dreaded disease," said Senator Specter (R-PA). "OraQuick is a U.S. manufactured test that produces results in 20 minutes. The approval reaffirms this Administration's commitment to work in conjunction with private and government partners to fight the HIV virus. OraQuick must be the new standard test for HIV testing, both in the U.S. and abroad."
Senator Rick Santorum (R-PA) also commented that, "This rapid test meets a critical global need as well as an important local need. The manufacturer of this new, oral fluid rapid HIV test technology right here in Pennsylvania will help grow the economy."
"More than 40 million people worldwide are living with HIV/AIDS, the majority of whom do not know they are harboring the most deadly virus in history and therefore spreading it to children and loved ones," said George W. Haley, former U.S. Ambassador to the Republic of the Gambia and brother of esteemed author Alex Haley. "Countries battling the war against AIDS should have complete access to the same technology that we use on ourselves and our families here in America. Because of its design, OraQuick can be used virtually anywhere, at anytime, and by anyone, with minimal cost, training and safety issues. Now is the time to scale up rapid testing and this simple test is one of the answers."
"We are extremely excited and honored that Secretary Thompson has personally announced this FDA approval. Today marks the culmination of a successful collaboration between government and the private sector," said Mike Gausling, president and chief executive officer of OraSure Technologies. "As the only FDA approved rapid HIV test that can be used on oral fluid, we have delivered a revolutionary technology. Its simplicity will enable more people to be tested and to receive treatment sooner. It is a major breakthrough for rapid diagnostic testing and an important milestone for the Company as we continue to build our leadership position in the oral fluid diagnostics market."
The OraQuick HIV-1/2 test is the first and only rapid, point-of-care test approved by the FDA for use with oral fluid, fingerstick and venipuncture whole blood, and plasma samples. Specifically, the FDA approved the use of the test in detecting antibodies to HIV-1 in oral fluid and antibodies to both HIV-1 and HIV-2 in plasma samples and has required the Company to perform certain post marketing studies. The OraQuick HIV-1/2 test had received prior FDA approval for use in detecting antibodies to both virus types in finger stick and venipuncture whole blood samples. OraSure is seeking a license to certain HIV-2 patents held by Bio-Rad Laboratories and is cautiously optimistic that a license will be obtained in the near future.