Gen-Probe and TECAN Expand DTS Platform for Robotic Processing of the APTIMA® Combo 2 Assay for Sexually Transmitted Disease (STD) Testing

New DTS™ 800 System Offers Alternative for Low to Mid-Volume Laboratory Customers

Orlando, FL., July 30, 2002 — Gen-Probe Incorporated and Tecan US., Inc. today announced the launch of the DTS 800 System for use in automated processing of the GEN-PROBE APTIMA Combo 2 Assay, an FDA-cleared nucleic acid test for the simultaneous detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), two of the leading causes of sexually transmitted disease. The DTS 800 System can process up to 400 APTIMA Combo 2 Assay samples per shift (800 STD results), and will complement the existing DTS 1600, capable of processing 800 APTIMA 2 Combo Assay samples (1600 STD results). The DTS 800 System is being introduced at the American Association of Clinical Chemistry's (AACC) 54th Annual Meeting and Clinical Lab Exposition, which is now under way in Orlando, Florida.

The APTIMA Combo 2 Assay is able to simultaneously detect and differentiate the presence of CT and NG in urine samples from both asymptomatic and symptomatic individuals and in endocervical and male urethral swab specimens. The process involves target capture, target amplification, and nucleic acid probe detection. In clinical studies conducted to date, the assay showed the highest sensitivity in comparison to competing methods and equivalent sensitivity with both swab and urine samples. In the past, adequate sensitivity with urine samples has been difficult to achieve. Gen-Probe's new DTS 800 System, which integrates the Tecan Genesis 100/4 RSP (Robotic Sample Processor), will offer an automated solution to detect the organisms that cause CT and NG.

"The DTS 800 System expands our potential market for the APTIMA Combo 2 Assay by offering cost-effective solutions for low to mid-volume laboratories, which represent an important market segment for Gen-Probe," said Henry L. Nordhoff, president and chief executive officer of Gen-Probe Incorporated. "Chlamydia trachomatis and Neisseria gonorrhoeae are two of the most common causes of sexually transmitted disease in the United States, and the infections often co-exist and complicate the clinical diagnosis. As a leader in STD testing, we developed the APTIMA Combo 2 Assay in response to a need for more rapid, sensitive and simultaneous detection of these pathogens to provide patients with more accurate diagnosis and timely treatment."

"We are pleased to be able to offer this new platform for the automation of these much needed diagnostic tests," said Carl Severinghaus, general manager of Tecan US. "The introduction of the DTS 800 System provides low to mid-volume diagnostic facilities with another option for automated nucleic acid testing. By using the Genesis 100/4 RSP processor, the system can be run in a user-friendly, high throughput fashion by laboratory technicians, reducing costs and saving on time and laboratory space."

According to the Centers for Disease Control and Prevention, or CDC, Chlamydia, the common name for infection with the bacterium Chlamydia trachomatis, is one of the most widespread bacterial STDs in the United States with more than 3 million new cases reported each year. Gonorrhea, the disease caused by the bacterium Neisseria gonorrhoeae, is the second most frequently reported STD in the United States. According to the CDC, each year approximately 650,000 people in the U.S. contract gonorrhea.

Unique benefits of the DTS 800 System include:

Improved Productivity

  • The technologist can process both urine and swab samples simultaneously. Urine specimens DO NOT require centrifugation; reducing cost and space while improving overall throughput for this test.

  • The unique penetrable cap of the APTIMA Combo 2 collection kit decreases the chance of contamination, increases throughput, and decreases the risk of repetitive motion injury to laboratory personnel.

  • Detection and identification of both pathogens from one collection tube and one reaction tube reduces workload and frees laboratory resources for other testing.

Improved Screening

  • Equivalent swab and urine sensitivity of the APTIMA Combo 2 assay opens the door to screening without invasive sample collection. This will be particularly helpful in screening men, who are often reluctant to provide urethral swab specimens.

  • Transport media stabilizes swab specimens for 60 days and urine specimens for 30 days at room temperature, which makes the APTIMA Combo 2 assay ideal for screening programs in public health and the military.

About Gen-Probe Incorporated

Gen-Probe Incorporated, based in San Diego, California, is a recognized world leader in the development, manufacture and commercialization of diagnostic products based on its patented genetic probe technologies. Gen-Probe has received over 40 FDA clearances for nucleic acid probe tests to detect a wide range of microorganisms, including those causing sexually transmitted diseases, tuberculosis, strep throat, pneumonia and fungal infections. Gen-Probe recently received FDA approval of its amplified viral nucleic acid tests for screening the blood supply for HIV-1 and hepatitis C viruses. These tests are currently used to screen over 70% of blood donations in the United States. In May 2001, the FDA cleared Gen-Probe's APTIMA Combo 2 Assay test for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae using a single specimen and test.

About Tecan

Tecan (www.tecan.com) is a leading player in the Life Sciences supply industry that specializes in the development, production and distribution of solutions enabling the discovery of pharmaceutical substances, as well as for genomics, proteomics and diagnostics. Tecan clients are leading pharmaceutical and biotechnology companies, university research departments and diagnostic laboratories. Founded in Switzerland in 1980, the company has manufacturing, research and development sites in both North America and Europe and maintains a sales and service network in 52 countries. In 2001, Tecan achieved sales of CH 361.9 million (USD 214.1 million; EUR 239.6 million). Registered shares of Tecan Group are traded on the Swiss SWX stock exchange (TK: TECN / Reuters: TECZn.S / Valor : 1210019).


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Contacts:

Lora L. Pike
Director, Investor Relations
Gen-Probe, Inc.
Tel: 858-410-8673
Fax: 858-410-8139
E-mail : lorap@gen-probe.com

Christophe Lamps
Rochat & Partners
Tel: +41 22 786 54 55
Fax: + 41 22 786 54 58
E-mail: clamps@rochat-pr.ch
Internet: www.tecan.com



Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121

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