Real-time PCR test validated using clinical specimens confirmed
positive for Influenza A H1N1 Swine-origin flu virus
MADISON, N.J., May 11 /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 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
CONTACT: Wendy Bost (Media), +1-973-520-2800, Laure Park (Investors),
+1-973-520-2900
Web Site: http://www.questdiagnostics.com
(DGX DGX)