News & Events

Sparks, MD USA (November 08, 1999) -- Becton, Dickinson and Company (BD) (NYSE: BDX) today announced it has received clearance by the Food and Drug Administration (FDA) to market its BDProbeTec™ ET System for the direct qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae, two of the most common causes of sexually transmitted diseases (STDs). The test has been cleared for use with endocervical swabs, male urethral swabs, and with female and male urine.

“Many clinicians recognize that chlamydia and gonorrhea are significant health issues. We believe the BDProbeTec™ ET System will help improve screening for these diseases in the large number of men and women who are infected but who do not have clinical symptoms. For women especially, this can lead to reductions in the severe complications of currently undetected disease, such as pelvic inflammatory disease and infertility,” said Caroline Popper, M.D., VP/GM, BDGene,the molecular diagnostics venture of BD Biosciences.

According to the U.S. Centers for Disease Control and Prevention (CDC), chlamydia is the most common sexually transmitted disease in the United States affecting an estimated 4 million Americans, predominantly women, every year. The incidence of gonorrhea infection in the U.S. is estimated to be in excess of 2 million cases annually. Clinical syndromes range from urethritis and cervicitis to pelvic inflammatory disease (PID), which can lead to infertility and ectopic pregnancy.

Sexually transmitted diseases such as chlamydia and gonorrhea have been shown to increase the risk of acquiring or transmitting the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency disease syndrome (AIDS). The Advisory Committee for HIV and STD Prevention has concluded that early detection and treatment of curable STDs, such as chlamydia and gonorrhea, should be implemented more widely as an HIV prevention strategy in the United States

A major concern with chlamydia and gonorrhea is that many individuals may be infected without having clinical symptoms. It has been estimated that 70-80% of women and up to 50% of men who are infected with chlamydia experience no symptoms. In addition, over 50% of women and up to 90% of men with gonorrhea are asymptomatic. Once diagnosed, chlamydia and gonorrhea are easily treated and cured. Numerous studies have shown that nucleic acid amplification techniques such as that utilized in the BDProbeTec™ ET System identify a significant number of infections that would otherwise go undetected.

The costs associated with chlamydia and its consequences are estimated at over $2 billion annually. In contrast, the CDC estimates that screening and treatment programs for chlamydia can be conducted at a cost of $175 million annually. Broad utilization of amplified methods such as BDProbeTec™ ET should help make screening programs more acceptable and effective.

“The BDProbeTec™ ET System is a significant new development in amplified testing for clinical molecular diagnostics,” said Dr. Popper. “The system’s design, workflow and ease-of-use overcome many of the practical concerns associated with the adoption of amplified systems, particularly in laboratories with higher workloads.”

The BDProbeTec™ ET System combines BD’s proprietary Strand Displacement Amplification (SDA) technology with an energy transfer (ET) detection method to provide one-hour assay time and multiple test runs per day. The system is designed to enhance productivity through increased instrument throughput, optimal workflow, and decreased time to result, and to improve result integrity through SDA sensitivity, pre-dispensed dried reagents and incorporation of an amplification control to identify inhibitory specimens.

BD manufactures and sells a broad range of medical supplies and devices and diagnostic systems for use by health care professionals, medical research institutions and the general public. For the fiscal year ended September 30, 1999, BD had total revenues of $3.4 billion and net income of $275 million.

This press release may contain certain forward-looking statements (as defined under Federal securities laws) regarding BD’s performance, including future revenues, products and income or events or developments that BD expects to occur or anticipates occurring in the future. All such statements are based upon current expectations of BD and involve a number of business risks and uncertainties. Actual results could vary materially from anticipated results described in any forward-looking statement. Factors that could cause actual results to vary materially from any forward-looking statement include, but are not limited to, competitive factors, changes in regional, national or foreign economic conditions, changes in interest or foreign currency exchange rates, delays in product introductions, Year 2000 issues, and changes in health care or other governmental regulation, as well as other factors discussed herein and in BD’s filings with the Securities and Exchange Commission.