Company's First FDA-Cleared Instrument Marks Key Milestone in Its Strategy to Serve Customers in Applied, Clinical and Validated SettingsFOSTER CITY, Calif., Sep 30, 2008 (BUSINESS WIRE) -- Applied Biosystems Inc. (NYSE:ABI) today announced that it has received
510(k) clearance from the U.S. Food and Drug Administration for its new
7500 Fast Dx Real-Time PCR Instrument for use with the new CDC Human
Influenza Virus Real-time RT-PCR Detection and Characterization Panel
(rRT-PCR Flu Panel) from the U.S. Centers for Disease Control and
Prevention. While both products received independent FDA 510(k)
clearances, they are required to be used together as a system for the
detection of influenza.
Together with the 7500 Fast Dx Real-Time PCR Instrument, the new CDC
diagnostic assay is designed to help standardize influenza virus testing
and sub-typing and provide accuracy, specificity and dependability of
influenza test results among qualified laboratories that conduct
influenza subtype testing in the United States. Developed through a
coordinated effort between the CDC and Applied Biosystems, the new test
can accurately detect and identify commonly circulating human influenza
viruses as well as avian influenza A (H5N1, Asian lineage) viruses
within four hours and in multiple samples at one time. The test enables
clinical researchers to discriminate between both the common seasonal
subtypes of flu as well as the avian influenza A subtype, in order to
aid public health officials in making a rapid and accurate diagnosis.
"The FDA's decision
to clear our real-time PCR instrumentation is an important milestone for
Applied Biosystems as it presents us with an exciting opportunity to
apply our technology to the rapidly growing clinical diagnostics market,"
said Mark Stevenson, president and chief operating officer for Applied
Biosystems. "In this instance, we've
been able to apply our real-time PCR technology to support laboratories
on the front line of influenza testing in the United States. This is an
important diagnostic tool that will enhance monitoring of influenza
infections each year and improve early detection of influenza viruses
with pandemic potential in the United States and abroad."
Applied Biosystems is a worldwide leader in real-time PCR instruments.
The 510(k) clearance for the 7500 Fast Dx Instrument is the company's
first clearance for a real-time PCR instrument for the clinical
diagnostics market. Real-time PCR (polymerase chain reaction) is a
common laboratory method which measures PCR amplification as it occurs,
cycle-by-cycle, allowing quantitative measurements to be made in the
highly reproducible exponential phase of PCR. This enables extremely
accurate and precise quantitation over a large dynamic range compared to
traditional techniques.
The 510(k) clearance for the 7500 Fast Dx Real-Time PCR Instrument
follows the recent ISO 13485:2003 Quality System certification for the
Applied Biosystems Singapore facility awarded by The British Standards
Institution Americas, Inc., which enables CE Marking to the In-Vitro
Diagnostics Directive 98/79/EC of products for sale within the European
Community.
The Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument employs
96-well format reaction plates and enables scientists to complete
real-time PCR amplification in less than 40 minutes. CDC-qualified
laboratories that previously purchased the 7500 Fast Real-Time PCR
System should contact their Applied Biosystems representative for
information on how to purchase a 'Dx'
upgrade to the 7500 Fast Dx Real-Time PCR Instrument for use with the
new CDC flu assay. For more information please visit http://www.appliedbiosystems.com.
About Applied Biosystems Inc.
Applied Biosystems Inc. (formerly known as Applera Corporation) is a
global leader in the development and marketing of instrument-based
systems, consumables, software, and services for academic research, the
life science industry and commercial markets. Driven by its employees'
belief in the power of science to improve the human condition, the
company commercializes innovative technology solutions for DNA, RNA,
protein and small molecule analysis. Customers across the disciplines of
academic and clinical research, pharmaceutical research and
manufacturing, forensic DNA analysis, and agricultural biotechnology use
the company's tools and services to
accelerate scientific discovery, improve processes related to drug
discovery and development, detect potentially pathogenic microorganisms,
and identify individuals based on DNA sources. Applied Biosystems has a
comprehensive service and field applications support team for a global
installed base of high-performance genetic and protein analysis
solutions. Applied Biosystems Inc. is headquartered in Norwalk, CT. On
June 12, 2008, Applera Corporation and Invitrogen Corporation
(NASDAQ:IVGN) announced that their Boards of Directors had approved a
definitive merger agreement under which Invitrogen will acquire all of
the outstanding shares of Applied Biosystems stock. The merger is
subject to customary closing conditions and is targeted to close in the
fall of 2008. Further information regarding the merger is contained in a
joint proxy statement/prospectus that has been mailed to stockholders of
the company and Invitrogen. Investors and security holders are urged to
read this document because it contains important information.
Information about Applied Biosystems, including reports and other
information filed by the company with the Securities and Exchange
Commission, is available at http://www.appliedbiosystems.com.
All information in this news release is as of the date of the release,
and Applied Biosystems does not undertake any duty to update this
information unless required by law.
Applied Biosystems Forward Looking Statements
Certain statements in this press release are forward-looking. These may
be identified by the use of forward-looking words or phrases such as "should,"
"expect," and "planned,"
among others. These forward-looking statements are based on Applied
Biosystems' current expectations. The Private
Securities Litigation Reform Act of 1995 provides a "safe
harbor" for such forward-looking statements.
In order to comply with the terms of the safe harbor, Applied Biosystems
notes that a variety of factors could cause actual results and
experience to differ materially from the anticipated results or other
expectations expressed in such forward-looking statements. These factors
include but are not limited to: (1) rapidly changing technology and
dependence on the development and customer acceptance of new products;
(2) sales dependent on customers' spending
policies; (3) diagnostic products may not receive required regulatory
clearances or approvals; (4) the markets for clinical laboratory testing
services and diagnostic products are very competitive, healthcare
providers may prefer to use better-known laboratories for clinical
testing, and healthcare providers may not accept new diagnostic products
developed by the company, and (5) other factors that might be described
from time to time in Applied Biosystems'
filings with the Securities and Exchange Commission.
(C)Copyright 2008. Applied Biosystems Inc. All
rights reserved. Applied Biosystems and AB (Design) are registered
trademarks of Applied Biosystems or its subsidiaries in the U.S. and/or
certain other countries.
SOURCE: Applied Biosystems Inc.
Applied Biosystems
Renaldo Juanso, 650-638-5354 (Media)
renaldo.juanso@appliedbiosystems.com
William Craumer, 650-638-6382 (Investor)
william.craumer@appliedbiosystems.com