Intercept Oral Fluid Drug Test Equivalent to Urine Drug Testing; Landmark Study Published in the Journal of Analytical Toxicology

BETHLEHEM, Pa.--(BUSINESS WIRE)--Dec. 20, 2002--OraSure Technologies, Inc. (Nasdaq:OSUR), the market leader in oral fluid diagnostics, announced today the publication of results of the first large-scale study of oral fluid drug testing in private industry with its Intercept(R) oral fluid drug testing system.

The results from the study demonstrate that oral fluid drug testing produces equivalent results to urine drug testing.

This study, entitled "Oral Fluid Testing for Drugs of Abuse: Positive Prevalence Rates by Intercept(R) Immunoassay Screening and GC-MS-MS Confirmation and Suggested Cutoff Concentrations," was published in the November/December 2002 issue of the Journal of Analytical Toxicology.

A total of 77,218 oral fluid specimens were collected and tested as part of the study using the Company's Intercept(R) lab-based oral fluid drug testing system. The study was performed by LabOne, Inc. (Nasdaq:LABS) as part of its Intercept(R) oral fluid drug testing service offered to the workplace testing market.

In the study, oral fluid specimens were screened for the basic five-drug panel (marijuana, cocaine, opiates, PCP, and amphetamines).

The positive prevalence rate for oral fluid specimens collected and tested using the Company's Intercept(R) collector and drug screening test was 5.06%, according to the study.

This rate is similar to urine drug prevalence rates reported for the general workforce according to the Quest Drug Testing Index over the same general period of 4.46%, indicating that oral fluid drug testing produces equivalent results to urine testing.

Sam Niedbala, Ph.D., the Company's Chief Science Officer, stated that, "This study is truly a milestone, in that it represents the first large-scale comparison of oral fluid and urine-based drug testing in the workplace setting. The study provides the strongest and most complete scientific demonstration that oral fluid drug testing produces equivalent results to urine drug testing. These results further confirm our leadership position in developing and bringing to market innovative oral fluid testing products for both drugs of abuse and infectious disease applications."

Mike Gausling, OraSure's Chief Executive Officer, added, "The Intercept(R) study provides a very compelling reason why businesses and other potential customers should consider converting their drug testing programs from urine to oral fluid specimen collection. In addition to the terrific performance data, we believe that oral fluid testing provides such added benefits as ease of use, a more dignified collection process, and substantially lower risk of sample adulteration, which is a significant issue for those who run a urine-based drug testing program."

Intercept(R) is the only FDA-cleared oral fluid drug testing system in the United States. The Intercept(R) system is used in both workplace and criminal justice testing markets. Since receiving FDA approval in 2000, the number of oral fluid specimens processed using the Intercept(R) Drug Testing System has grown to more than 50,000 per month.

It is estimated that the overall size of the domestic market for drugs of abuse testing is approximately 42 million specimens per year.

About OraSure Technologies

OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices and tests and other diagnostic products using its proprietary technologies, including immunoassays and other in vitro diagnostic tests and other medical devices.

These products are sold in the United States and certain foreign countries to government agencies, clinical laboratories, physicians' offices, hospitals, commercial and industrial entities, and various distributors.

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-1. 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.

Important Information

This press release contains certain forward-looking statements, including with respect to technology, products, and product performance. Actual results could be significantly different.

Factors that could affect results include the ability to market products; impact of competitors, competing products and technology changes; ability to develop, commercialize and market new products; market acceptance of oral fluid testing products and up-converting phosphor technology products; ability to fund research and development and other projects and operations; ability to obtain and timing of obtaining necessary regulatory approvals; ability to develop product distribution channels; uncertainty relating to patent protection and potential patent infringement claims; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally; loss or impairment of sources of capital; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; changes in relationships with strategic partners and reliance on strategic partners for the performance of critical activities under collaborative arrangements; changes in accounting practices or interpretation of accounting requirements; customer inventory practices and consolidations; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; and general business, political and economic conditions.

These and other factors are discussed more fully in the Securities and Exchange Commission filings of OraSure Technologies, including its registration statements, its Annual Report on Form 10-K for the year ended December 31, 2001, and its Quarterly Reports on Form 10-Q.

Although forward-looking statements help to provide complete information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.