Press Release
Abbott's HIV-1 Viral Load Test Approved by FDA for Use on New m2000™ Molecular Diagnostics Instrument
More than 2 million HIV viral load tests performed annually in the United
States; U.S. launch of m2000 instrument and HIV-1 test represents substantial
improvement over existing methods to detect and measure HIV-1 and all known
genetic variations of the virus
Des Plaines, Illinois, and Rockville, Maryland, May 14, 2007 — Abbott (NYSE:
ABT) and Celera (NYSE:CRA), an Applera Corporation business, announced today
that Abbott has received U.S. Food and Drug Administration (FDA) approval to
market the Abbott RealTime HIV-1 viral load test
for use on the company's m2000™ automated instrument system.
The Abbott RealTime HIV-1 assay, for use on the new m2000 system, is
designed to detect and precisely measure levels of the human immunodeficiency
virus (HIV) circulating in a patient's blood (viral load), including the three
major groups of HIV-1 as well as non-B subtypes.
The test is intended for use as a marker of disease prognosis and an aid in
assessing viral response to antiretroviral treatment.
"As the viral diversity of HIV-1 continues to increase, the need for
highly sensitive tests to monitor patient response to antiviral therapies
becomes even more important,” said John Robinson, Ph.D., senior director,
research and development, Abbott Molecular. "The reliability and precision
of the Abbott RealTime HIV-1 test on the
m2000 system for detecting HIV-1 subtypes
across a broad dynamic range should help physicians be confident about
assessing viral levels in their patients, enabling them to provide optimal
treatment."
HIV-1 can be divided into groups M (major),
O (outlier) and N
(new). The vast majority of isolates cluster in the M group. Distinct lineages within group M have also been identified, and these lineages
are called strains or subtypes. They include subtype designations A through G. While HIV-1 subtype B continues
to be the most common strain found in the United States, studies suggest that
an increasing number of newly diagnosed patients are infected with non-B subtype viruses and various circulating
recombinants as a result of the influx of immigrants from countries where
variant strains of HIV are more common. In a recent study published in the
Journal of Medical Virology1 examining the impact of this phenomenon
on Minneapolis-based Hennepin County Medical Center, the predominant HIV
subtypes identified by the hospital in African-born patients were subtype C (40 percent),
followed by A (20-25 percent), D (10 percent) and G (3-5
percent).
Another recent study by the Centers of Disease Control and Prevention
involving more than 3,000 HIV patients in the United States found that 5.1 percent of those patients were infected with HIV-1 non-B subtypes.2
”The ability to detect and measure each of these genetic variations of the
virus is an important factor in managing the disease on a worldwide basis and
determining the most effective course of treatment for patients,” said Timothy
Stenzel, M.D., Ph.D., medical director, Abbott Molecular.
The RealTime HIV-1 test has been developed for use on the Abbott
m2000 system, an automated instrument for DNA and RNA testing in
molecular laboratories. The m2000 system is based on real-time
polymerase chain reaction (PCR) technology and is designed to efficiently
detect and measure life-threatening viruses and bacteria in patient samples in
less than five hours, compared to other testing methods that may take up to two
days.
Additional products in development for the Abbott m2000 system
include assays for hepatitis C virus (HCV), hepatitis B
virus (HBV), HCV genotyping, chlamydia and gonorrhea. Abbott markets the
m2000 system and a menu of tests throughout the world as part of a
strategic alliance with Celera.
“We're very pleased that Abbott, through its alliance with Celera, has
secured FDA approval on a real-time viral load assay for HIV,” said Kathy
Ordoñez, president, Celera. "Today, more than 2 million HIV viral load
tests are performed annually in the United States, and we believe both the
Abbott RealTime HIV assay and the m2000 system offer substantial
productivity and performance advantages to customers performing these
tests.”
About the Abbott RealTime HIV-1 Viral Load Test
The Abbott RealTime HIV-1 assay, for use on the m2000 system, is
among the most sensitive viral load tests available today, with a broad dynamic
range, capable of quantitating HIV-1 in plasma
down to as few as 40 RNA molecules per milliliter (mL) and up to as many as 10 million
molecules per mL. The Abbott RealTime HIV-1 assay is intended for use in conjunction
with clinical presentation and other laboratory markers as an indicator of
disease prognosis and for use as an aid in assessing viral response to
antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. This assay is not intended to be used
as a donor-screening test for HIV-1 or as a
diagnostic test to confirm the presence of HIV-1
infection.
About the Abbott m2000
The Abbott m2000 system consists of two instruments: the Abbott
m2000sp and the m2000rt. The system's sophisticated computer
software links an instrument that automates the extraction, purification and
preparation of DNA and RNA from patient samples (m2000sp) with a
real-time PCR instrument that amplifies, detects and measures minute levels of
infectious agents (m2000rt). The system automates a variety of manual
processing steps, such as pipetting, helping to reduce the hands-on time
required to prepare patient samples for DNA/RNA testing by as much as 75 percent.
"By automating all of the complex, manual steps often associated with
molecular testing, the m2000 system gives molecular laboratories the
ability to prepare patient samples and deliver test results fast and
efficiently," said Scott Safar, senior director, systems development and
support, Abbott Molecular. “We believe the ease of use and sample tracking
features of the instrument have taken automation to another level for molecular
laboratories.”
The m2000 system and a menu of tests for HIV-1, HCV, Chlamydia trachomatis (CT) as well
as a combination test for CT/Neisseria gonorrhoeae are available in the
European Union as CE-marked products.
Learn more about the m2000 system and watch an animation video
explaining how it operates.
About Applera Corporation and Celera
Applera Corporation consists of two operating groups: Celera and the Applied
Biosystems groups. Celera is primarily a molecular diagnostics business that is
using proprietary genomics and proteomics discovery platforms to identify and
validate novel diagnostic markers, and is developing diagnostic products based
on these markers as well as other known markers. Celera maintains a strategic
alliance with Abbott for the development and commercialization of molecular, or
nucleic acid-based, diagnostic products, and is also developing new diagnostic
products outside of this alliance. Through its genomics and proteomics research
efforts, Celera is also discovering and validating therapeutic targets, and has
established and is seeking strategic partnerships to develop therapeutic
products based on these discovered targets. The Applied Biosystems Group serves
the life science industry and research community by developing and marketing
instrument-based systems, consumables, software, and services. Customers use
these tools to analyze nucleic acids (DNA and RNA), small molecules, and
proteins to make scientific discoveries and develop new pharmaceuticals.
Applied Biosystems' products also serve the needs of some markets outside of
life science research, which is referred to as “applied markets,” such as the
fields of: human identity testing (forensic and paternity testing);
biosecurity, which refers to products needed in response to the threat of
biological terrorism and other malicious, accidental, and natural biological
dangers; and quality and safety testing, for example in food and the
environment.
Applied Biosystems is headquartered in Foster City, CA, and reported sales
of over $1.9 billion during fiscal 2006.
Information about Applera Corporation, including reports and other information
filed by the company with the Securities and Exchange Commission, is available
at http://www.applera.com, or by telephoning 800.762.6923. Information about Celera is available at
http://www.celera.com.
Applera Corporation's 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
"believe," "plan," and "should," among others. These
forward-looking statements are based on Applera Corporation's 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, Applera 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) uncertainty that
the Abbott RealTime HIV-1 and HCV assays or the m2000 system will
be accepted by the market, including the risk that these products will not be
competitive with products offered by other companies; and (2) other factors
that might be described from time to time in Applera's filings with the
Securities and Exchange Commission. All information in this press release is as
of the date of the release, and Applera does not undertake any duty to update
this information, including any forward-looking statements, unless required by
law.
About Abbott's Molecular Diagnostics Business
Abbott Molecular, a division of Abbott based in Des Plaines, Illinois, is an
emerging leader in molecular diagnostics – the analysis of DNA, RNA and
proteins at the molecular level. Abbott Molecular's instruments and tests
provide physicians with critical information based on the early detection of
pathogens and subtle, but key changes in patients' genes and chromosomes. They
help physicians diagnose disease and infections earlier, select appropriate
therapies and monitor disease progression.
Abbott Molecular's portfolio of products includes innovative genomic tests
for chromosome changes associated with congenital disorders and cancer,
including the PathVysion® HER-2 DNA
Probe Kit, a test used to help select women with breast cancer who could
benefit from Herceptin® therapy, and UroVysionTM, which
detects genetic changes in bladder cells for aiding in the diagnosis of bladder
cancer in patients with hematuria (blood in the urine) and for monitoring
bladder cancer recurrence.
About Abbott
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The company
employs 65,000 people and markets its products in more than 130 countries.
| 1 |
Journal of Molecular Virology, Cartwright, 2006 |
| 2 |
Abstract of the 14th Conference on Retroviruses and
Opportunistic Infections, Mahle K, Bodnar U, et al., 2007 |
Abbott
Media:
Don Braakman |
(224) 361-7246 |
Financial:
Tina Ventura |
(847) 935-9390 |
Celera
Media & Financial:
David Speechly, Ph.D. |
(510) 749-1853 |
