TwitterLinkedInFacebook Instagram
United StatesLanguage Flag

Press Release

OraSure Technologies Announces First International Order for OraQuick Rapid HIV Test

October 23, 2000 at 12:00 AM EDT

First Clinical Trial Results Available

BEAVERTON, Ore.--(BW HealthWire)--Oct. 23, 2000--OraSure Technologies, Inc. (Nasdaq:OSUR - news) today announced its first international order for the unique OraQuick® HIV-1/2 rapid test.

The OraQuick product detects HIV disease from an oral fluid sample within 20 minutes after collection.

The initial order of 100,000 units came from Edison Africa (S.A.) (Pty) Ltd., OraSure Technologies' new distributor in South Africa. OraSure Technologies expects that Edison Africa will be ordering over one million units per year by the end of 2001. In addition to distributing OraQuick to health care providers, Edison Africa is planning to provide an infrastructure of HIV-AIDS mobile testing/counseling centers. Approval to import OraQuick into South Africa has already been received from the Medicines Control Council in that country.

''This order is a milestone for OraSure Technologies, representing both the first international order and a lynchpin in our strategy for sub-Saharan Africa. The opportunity for OraQuick in this geographic area is enormous, as international agencies recognize the need for funding screening and prevention programs,'' said Robert D. Thompson, chief executive officer of OraSure Technologies. ''Our agreement with Edison Africa positions us well to satisfy the need for rapid HIV testing in sub-Saharan Africa.''

''We have expended a great deal of time researching the global markets in order to find a product which is simple to administer and particularly one that does not require a blood sample. We believe the OraQuick device, used in conjunction with pre and post test counseling, which is in accordance with the South African government policy, will provide the simplest and most cost effective method of screening for HIV,'' said Mr. Vivian Reddy, Chairman and CEO of Edison Africa.

Africa is home to an estimated 25 million of the 34 million HIV-AIDS infected persons in the world. About four million infected individuals live in South Africa, representing roughly 20% of South Africa's adult population and more cases than in any other country.

OraSure Technologies and Edison Africa will donate a portion of the profits from the sale of OraQuick to the Orphans of AIDS Foundation, a program that assists the estimated ten million children orphaned by HIV-AIDS currently living in Africa.

''The scourge of HIV-AIDS in our country must be addressed as an absolute priority. The socio- economic impact on our society cannot be underestimated. We welcome an innovative product such as OraQuick to assist us in the process of combating HIV-AIDS,'' said His Majesty King Goodwill Zwelithini Zulu.

''The suffering of children caused by the pandemic HIV-AIDS cannot be quantified. In many cases, elderly pensioners have to care for the children because the parents have died and left no money for food, clothing or education,'' commented His Excellency Jacob Zuma, Deputy President of the Republic of South Africa and Chairman of the Presidential Counsel on AIDS. ''The Orphans of AIDS Foundation seeks to assist in this dreadful plight. I thank OraSure Technologies and Edison Africa for their generous gesture. We look forward to their continued support and hopefully the support of other companies led by this example.''

OraQuick Clinical Studies

The first international clinical trials for OraQuick HIV were conducted in Bangkok, Thailand, in conjunction with the Thai Red Cross AIDS Research Center. The study collected matched samples from 1,000 subjects who were considered to be at high risk for HIV infection and used both oral fluid, whole blood and plasma samples on OraSure's new OraQuick HIV rapid test device. OraQuick samples resulted in 100% sensitivity and 99.9% specificity as compared to blood-based laboratory screening and confirmatory tests.

OraSure Technologies has begun its own clinical trials of OraQuick HIV in the United States in preparation for anticipated submission to the Food and Drug Administration in early 2001. OraQuick HIV is the first product in the OraQuick line, which the company plans to expand to include tests for a variety of infectious diseases.

About OraSure

OraSure Technologies, Inc. develops, manufactures and markets medical devices and diagnostic products for use by public- and private-sector clients, clinical laboratories, physicians' offices and workplace testing. OraSure Technologies is the leading supplier of oral fluid collection devices and assays to the life insurance industry and public health markets for the detection of antibodies to HIV. In addition, the company supplies oral fluid testing solutions for drugs-of-abuse testing. For more information on the company please go to www.orasure.com.

This press release contains forward-looking statements. Actual results could be significantly different. Factors that could affect results include loss of key personnel; failure to comply with regulations of the FDA or other regulatory agencies; obstacles to international marketing of products; loss or impairment of sources of capital; ability to develop product distribution channels; ability to develop new products; development of competing products; market acceptance of oral fluid testing products; and changes in international, federal or state laws or regulations. Although forward-looking statements help to provide complete information about future prospects, readers should keep in mind that forward-looking statements are much less reliable than historical information.

Contact:
OraSure Technologies
Charles E. Bergeron, CFO, 503/641-6115
www.orasure.com
or
Michelle Sells, 503/520-6233 (investor relations)
Investorinfo@orasure.com

© OraSure Technologies., 2024