BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Monday, 18 November 1996.
The test is being sold by Beacon's regional distributor, The Oduber Agencies, both to medical providers and over-the-counter for personal home use.
OraScreen HIV Rapid Test is a simple, multi-step dipstick system that can be performed in the physician's office or at home in 15 minutes, without the need for technical training, instruments or a laboratory. Unlike the new mail-in blood tests that were recently introduced in the United States by Johnson & Johnson and Home Access Health Corp., the OraScreen HIV Rapid Test uses saliva, provides immediate results and costs a fraction of the mail-in, blood-based products.
"We decided to initially release the OraScreen test in a relatively small geographic area in order to control the launch and prepare our distributors for future worldwide marketing," stated Jerome Mattingly, Ph.D., President of Beacon. "The market in the Caribbean is also unique, due to the area's extensive tourism. This launch will provide health care professionals, tourists and local consumers with access to the test."
U.S. Clinical Trials Planned
In preparation for U.S. testing, Beacon announced that it has signed a manufacturing agreement with Continental Laboratory Products of San Diego for production of the OraScreen HIV Rapid Test. Beacon plans to begin FDA related clinical trials of the saliva-based HIV test in the U.S. in early 1997. In the U.S., Beacon will seek approval to market the test to professional health practitioners. Later in 1997, Beacon expects to seek FDA approval to market a "Mail-In" version of the test for home use.
The Continental Laboratory Products agreement will provide Beacon with access to a GMP production facility, located in Tijuana, Mexico. This facility has been approved by the Food and Drug Administration and can be used to manufacture HIV tests for the U.S. market. Beacon also recently has commenced manufacturing its product in Genelabs Diagnostics' ISO 9000 approved facility in Singapore.
"Our strategy is to use multiple contract manufacturing sites around the world to ensure an adequate and reliable supply of the OraScreen HIV Rapid Test. In addition, this strategy allows us to conserve capital we would otherwise spend on factories and use it to accelerate new product development," Mattingly said. The Company has already received more than $36 million in purchase commitments from its first seven distribution agreements.
Beacon Diagnostics Inc. develops, manufactures and markets diagnostic products for the rapid detection of antibodies and antigens in noninvasive specimens, such as saliva. The Company's first product, OraScreen HIV Rapid Test, is a dipstick system for the detection of HIV in saliva.
In addition to the OraScreen technology, the Company has in development three other platform technologies to expand its range of diagnostic products using non-invasive specimens. The first is a new Antigen Detection technology for detecting several cancers, including colon, prostate, ovarian and breast cancers.
The second is a "Mail-In" test format that is a hybrid between the OraScreen technology and the ELISA technology normally used in a clinical laboratory.
The third is the LIDA technology, a novel homogenous phase platform technology being developed for use in detecting either antigens or antibodies. The LIDA technology is being developed to produce one-step, point-of-care tests and may be licensed to manufacturers of clinical chemistry analyzers to allow detection of antigens and antibodies using automated instruments.
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CONTACT: Beacon Diagnostics Inc. Jerome Mattingly Ph.D., 415/574-4800
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Copyright © 1996 - Business Wire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Business Wire, Permissions Desk, Business Wire, 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036; Tel: (212) 575-8822; FAX: (212) 575-1854. http://www.businesswire.com.
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