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Quest Diagnostics Introduces
First Commercial Laboratory Test
for Identifying the H1N1 Swine Flu Virus
Real-time PCR test validated using clinical specimens confirmed positive for
Influenza A H1N1 Swine-origin flu virus
MADISON, N.J., May 11, 2009 /PRNewswire-FirstCall/ --
Quest Diagnostics Incorporated
(NYSE:DGX), the world's leading provider of
diagnostic testing, information and services, today announced that
its Focus Diagnostics infectious disease reference laboratory has introduced
a laboratory-developed real-time
polymerase chain reaction
(PCR) test to aid in identifying Influenza A H1N1 Swine-origin (H1N1) flu
virus ("S-OIV" or "novel H1N1"), also known as the Swine Flu. The Focus
Diagnostics Influenza A H1N1 (Swine Flu) RNA Real-Time RT-PCR Test is the
first laboratory testing service to be introduced by a commercial laboratory
to aid in the identification of patients infected with the novel H1N1 virus
and differentiate patients infected with other seasonal Influenza A
strains. Focus Diagnostics has a track record of being first to market with
new laboratory testing services for
emerging infectious diseases,
such as West Nile Virus,
SARS, and chikungunya
virus.
"Our new laboratory test will be an important tool to help
health care professionals
and public health authorities
identify infected H1N1 patients more quickly, promoting earlier diagnosis
and treatment," said Jon R. Cohen, M.D., senior vice president and chief
medical officer, Quest Diagnostics. "This capability could be particularly
important if the novel H1N1 virus continues to spread in the U.S. or
re-emerges this fall or winter.
Public health officials
in the U.S. have done an exceptional job of managing the current Influenza
emergency, and we continue to work closely with them to assist their
preparedness efforts."
Focus Diagnostics validated its new Influenza A H1N1 (Swine Flu) RNA
Real-Time RT-PCR Test using clinical specimens submitted to its reference
laboratory confirmed as positive for the novel H1N1 influenza virus by
public health authorities. Real-time PCR is a highly sensitive testing
technique that can detect the presence of a virus' RNA from a patient's
nasal or nasopharyngeal specimen. The S-OIV virus responsible for a recent
outbreak affecting dozens of countries is a subtype of
Influenza virus Type
A. The new Focus Diagnostics test simultaneously detects the presence of
Influenza A virus RNA
and specifically identifies the presence of the novel H1N1 virus.
Focus Diagnostics will perform the Influenza A H1N1 (Swine Flu) RNA
Real-Time RT-PCR laboratory test, in alignment with current
public health guidelines,
at its reference laboratory in Cypress, California. Physicians, hospitals
and other health care
practitioners may order the laboratory test directly from Focus
Diagnostics or through the
Quest Diagnostics national laboratory network. Expected turnaround
time for reporting results is within 24 hours of receipt of specimen by the
Focus Diagnostics laboratory.
In addition to the new Influenza A H1N1 (Swine Flu) RNA Real-Time RT-PCR
Test, Quest Diagnostics' regional laboratories, including the Focus
Diagnostics reference laboratory, perform a broad range of testing services
to detect Influenza viruses, including PCR,
rapid cell culture,
direct immunofluorescence (DFA) and enzyme immunoassay (EIA) techniques.
Depending on the laboratory, the company can perform testing on different
types of collected specimens, such as nasopharyngeal swabs, nasal
secretions, nasal wash (lavage) and aspirations.
Public health guidelines are governed at the federal, state and county
level, and vary across the U.S. While state and
county public health
guidelines initially required private
clinical laboratories to provide positive Influenza virus type A
positive specimens to public health authorities for confirmatory testing and
diagnosis of novel H1N1 virus
infection, some state and county public health authorities now only
require confirmatory testing for specimens from certain
high risk patients or
under certain circumstances.
With the availability of the Focus Diagnostics Influenza A H1N1 (Swine Flu)
RNA Real-Time RT-PCR Test, physicians will be able to submit patient
specimens that are found to be positive for Influenza virus type A through
testing performed by a Quest Diagnostics' regional laboratory or other
private
clinical laboratory to Focus Diagnostics' reference laboratory for
novel H1N1 laboratory testing. A physician that believes a patient is at
high risk of novel H1N1 infection may order the new Focus Diagnostics test
to aid the diagnosis of Influenza virus type A infection, including the
novel H1N1 virus. Focus Diagnostics would also submit those test specimens
found to be positive as well as the test results to the appropriate public
health authorities, as required by
local public health
guidelines.
"The availability of the new Focus Diagnostics laboratory test will enable
physicians and hospitals to quickly identify patients infected with S-OIV
and differentiate them from patients infected with other Influenza A
strains," said Jay M. Lieberman, M.D., medical director, Focus Diagnostics.
"We will continue to aid our public health colleagues in responding to the
H1N1 outbreak, and encourage clinicians to follow testing guidelines
provided by public health authorities."
Focus Diagnostics has collaborated with the
U.S. Centers for Disease
Control and Prevention, the
World Health Organization
and other public health
agencies to help identify and develop diagnostic tests for emerging
infectious diseases. Focus Diagnostics was instrumental in developing the
first laboratory developed test for West Nile Virus after it was identified
in New York in 1999. Focus Diagnostics also introduced the first laboratory
developed test for SARS and the first FDA-cleared
serological test kit
for
Lyme disease.
For more information about Quest Diagnostics and Influenza testing options,
please visit
www.QuestDiagnostics.com/SwineFlu.
About Focus Diagnostics
Focus Diagnostics, Inc. is an
infectious disease diagnostics company, providing infectious disease
reference laboratory services to hospitals and laboratories nationwide, and
manufacturing and distributing diagnostic products worldwide. Focus
Diagnostics develops innovative tests and products to assist physicians in
diagnosing
infectious diseases, and often provides the first diagnostic tests in
the U.S. for emerging diseases, such as West Nile Virus and SARS.
HerpeSelect(R) type-specific
HSV serology and West Nile Virus DxSelect(TM) are top-selling Focus
Diagnostics products used in laboratories worldwide. Focus Diagnostics is a
wholly owned subsidiary of Quest Diagnostics. Visit
www.focusdx.com
for additional information.
About Quest Diagnostics
Quest Diagnostics is the world's leading provider of diagnostic testing,
information and services that patients and doctors need to make better
healthcare decisions. The company offers the broadest access to diagnostic
testing services through its network of laboratories and patient service
centers, and provides interpretive consultation through its extensive
medical and scientific staff. Quest Diagnostics is a pioneer in developing
innovative diagnostic tests and advanced healthcare information technology
solutions that help improve patient care. Additional company information is
available at
www.questdiagnostics.com.
Source: Quest Diagnostics Incorporated
Web Site:
http://www.questdiagnostics.com/ |
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