OraSure Technologies Announces Phase II Funding for Syphilis Project; NIH Approves Nearly $1 Million in Added Funding for Oral Fluid Syphilis Test
BEAVERTON, Ore.--(BW HealthWire)--Nov. 8, 2000--OraSure Technologies, Inc. (Nasdaq:OSUR), the market leader for oral fluid diagnostics of infectious disease and drugs-of-abuse, today announced that the National Institutes of Health (NIH) has approved a grant of nearly $1 million to fund Phase II of the Company's project to develop a test for syphilis using either blood or oral fluid samples.
This "fast-track" grant came after OraSure Technologies reached specific milestones set in Phase I, which was funded with approximately $118,000 from the NIH in September 1999. OraSure Technologies has until August 31, 2001, to complete the milestones necessary to collect the Phase II funds.
OraSure Technologies' syphilis project is focused on the development of tests for syphilis that will both screen and confirm the result using an oral fluid sample from an OraSure(R) oral specimen collection device. The tests will be performed in a laboratory using the same procedures that are used with OraSure HIV samples.
"By developing new tests across our three platform technologies - OraSure(R), OraQuick(R) and UPlink(TM), we can maximize the market coverage we achieve from projects like this syphilis research," said Robert D. Thompson, chief executive officer of OraSure Technologies. "The ultimate users of our products will range from lab-based testing for clinics to street corner outreach testing, and will be offered as part of a panel of tests or on a stand-alone basis."
The syphilis project represents another extension of the Company's laboratory based oral fluid technology platform into expanded diagnostics applications. OraSure is currently used for detection of HIV-1 antibodies, drugs-of-abuse and cotinine (for smoking). OraSure Technologies is also working outside the scope of this grant to expand this technology to include tests for hepatitis and markers for diabetes.
In addition to laboratory-based testing using an oral fluid sample, OraSure Technologies intends to expand syphilis testing to the point-of-care testing markets in the future. This includes the OraQuick rapid test, which can use either an oral fluid or a blood-based sample to produce results in about 20 minutes.
OraSure Technologies also intends to add the syphilis test to its future UPlink product development plans. Along with other tests on the same sample, this product will provide a multiple test format for public health testing. The UPlink product line utilizes the Company's patented UPT (Up-converting Phosphor Technology) in a point-of-care machine-readable format that can use an oral fluid or other type of sample to provide laboratory levels of accuracy in less than 10 minutes.
It is estimated that approximately 36 million syphilis tests are performed each year in the United States. That number is expected to increase due to the CDC's (Center for Disease Control and Prevention) program for the elimination of syphilis initiated in October 1999. This multi-year program requires an increased testing effort in order to identify new cases of syphilis and begin treatment before transmission can occur. The Company also expects to distribute the syphilis tests to international markets.
Although the incidence of syphilis in the U.S. is at an all-time low, there are geographic pockets of outbreaks that pose a significant public health problem and have the potential to spread. There were 12 million new cases of syphilis among adults worldwide during 1995, according to the World Health Organization.
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:
for OraSure Technologies, Inc.
Chief Financial Officer
Charles E. Bergeron, 503/641-6115
www.orasure.com
or
Investor Relations Manager
Michelle Sells, 503/641-6115
Investorinfo@orasure.com
