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Back To Vidyya OraQuick® Rapid HIV Test Demonstrated To Global AIDS/HIV Policy Leaders

Oral Fluid Test For HIV 1 And 2 Provides Highly Accurate Results In About 20 Minutes

Epitope, Inc has introduced the OraQuick(R) HIV-1/2 rapid HIV test to global AIDS/HIV policy leaders and decision makers attending the XIII International AIDS Conference currently underway in Durban, South Africa.

Beginning at a reception held the evening of July 8, and attended by His Excellency Jacob Zuma, Deputy President of the Republic of South Africa and Chairman of the Presidential Council on AIDS, His Majesty King Goodwill Zwelithini and other high ranking officials of the South African government, Epitope executives presented information related to the performance of the Company's newest product, OraQuick HIV-1/2. The Company released recent clinical data and discussed the advantages of this portable, non-invasive oral fluid test for HIV 1 and 2 antibodies, which provides highly accurate results in about 20 minutes.

In demonstration of its commitment to helping the victims of HIV/AIDS, Epitope presented an initial contribution to the Orphans of AIDS charity and committed to ongoing funding from sales of OraQuick. Epitope is also donating 5000 OraQuick HIV-1/2 devices to a program sponsored by Bristol-Myers Squibb Company addressing Mother-to-Child Transmission of HIV.

In clinical studies performed to date on multiple specimen types covering approximately 950 HIV-positive and 1700 HIV-negative subjects, test sensitivity has been 100% and specificity has been 99.9%. OraQuick will now be evaluated in the next phase of testing in Los Angeles by the Centers for Disease Control and Prevention (CDC) with 6000 subjects at high risk for HIV exposure. Additional Company-sponsored testing has already started in Thailand, and will soon begin in the Ivory Coast and Uganda in collaboration with prestigious research organizations. Clinical studies will also commence at over 20 sites in the U.S. during the third quarter of 2000. The international studies are expected to further demonstrate the wide applicability and effectiveness of OraQuick HIV-1/2 in developing countries where various subtypes of HIV exist, while the U.S. studies will be used to establish the necessary data for regulatory submission to the U.S. Food and Drug Administration (FDA).

"Early detection of HIV is the first step in an effective AIDS prevention and treatment program." said Robert D. Thompson, president and chief executive officer of Epitope. "Unfortunately, prevailing testing methodologies require a venipuncture or finger-stick to collect a sample for analysis. People in many cultures are averse to needles. As a result, a large number of at-risk individuals go untested. Additionally, the time lag between sample collection and the availability of test results prevents immediate counseling of infected individuals. Consequently, as many as 20-40% of patients who are tested do not actually receive their test results. By bringing non-invasive oral fluid testing to the point of care with laboratory-quality results in 20 minutes, OraQuick HIV-1/2 addresses these barriers to effective screening programs. We believe our product is the best tests available for rapid HIV testing in the international marketplace, and we have enjoyed an excellent reception in virtually all the geographies we have targeted."

OraQuick HIV-1/2 is a visually read, qualitative, in vitro immunoassay that detects antibodies to HIV (types 1 or 2) present in oral fluid, whole blood, serum or plasma. To use OraQuick HIV-1/2, the test subject gently swabs his/her upper and lower outer gums with the flat pad end of the device. The device then is placed into a vial containing developer solution. Alternatively, a whole blood, serum or plasma specimen can be immersed into the developer solution and swirled to mix; the OraQuick HIV-1/2 device is then placed into the developer solution. After about 20 minutes, a colored line appears in the results window in the "C" or "control" area to show the test has run properly, and for positive results another line appears in the "T" or "test" area. No accessories are required to run the oral fluid test, and the product can be stored at room temperature.

In April 2000 the Company filed an Investigational Device Exemption (IDE) with the FDA for HIV testing using OraQuick HIV-1/2. The IDE application calls for testing about 7,000 samples at approximately 20 sites in the U.S. to provide data to support an application to the FDA for approval to sell OraQuick HIV-1/2 in the U.S. market. The Company received IDE approval on June 23, 2000 and plans to initiate clinical trials during third quarter 2000. Epitope expects to file a premarket approval application in January 2001 for HIV-1/2 screening using OraQuick on oral fluid, whole blood, serum or plasma samples.

The XIII International AIDS Conference held July 9-14 in Durban, South Africa is the world's premier conference on AIDS/HIV, with attendance expected to exceed 12,000. Participants include leading AIDS/HIV scientists and clinicians, healthcare workers, public health agencies, people with AIDS, politicians, AIDS non-governmental organizations and AIDS service organizations from around the world.


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Editor: Susan K. Boyer, RN
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