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: |
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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
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