MADISON, N.J., July 24 /PRNewswire-FirstCall/ -- Quest Diagnostics
Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing,
information and services, today announced that the U.S. Food and Drug
Administration (FDA) has granted an emergency use authorization to the
company's Focus Diagnostics business for its test for detecting the 2009 H1N1
influenza virus (the "pandemic flu virus"), a strain of influenza A virus
initially referred to as the swine flu virus.
The Influenza A H1N1 (2009) Real Time RT-PCR test is the first commercial
lab test to be granted an emergency use authorization by the FDA for testing
for the 2009 H1N1 influenza virus. It is also the first test to qualitatively
detect RNA of the pandemic flu virus in a patient's nasal or nasopharyngeal
specimens. The test targets two separate regions of the hemagglutinin gene of
the 2009 H1N1 influenza virus to differentiate the presence of the pandemic
virus from seasonal human influenza A virus. Turnaround time for reporting
results is typically within 24 hours of receipt of specimen.
"This emergency use authorization means that the Influenza A H1N1 (2009)
Real Time RT-PCR, when combined with clinical and epidemiological assessments,
can aid physicians in diagnosing patients infected with the 2009 H1N1
influenza virus versus other influenza A virus strains," said Jon R. Cohen,
M.D., senior vice president and chief medical officer, Quest Diagnostics.
"This capability could be critically important in aiding clinicians in
determining which Influenza A virus is causing an infection should there be a
surge in flu cases during the fall and winter flu season. We will continue to
work closely with public health officials, who have done an outstanding job
managing the pandemic, to mitigate its effect on public health."
Quest Diagnostics' Focus business, which has a track record of being first
to market with new laboratory testing services for emerging infectious
diseases, developed and, in May 2009, launched the laboratory developed test
to help offload an expected backlog of testing from public health
laboratories. In the U.S., public health labs employ the CDC's rRT-PCR test,
which the FDA authorized for emergency use in April 2009. Public health labs
may use the CDC test to determine if certain high-risk patients who test
positive for influenza A virus by commercial tests are infected with the
pandemic flu virus.
Since Focus Diagnostics began to perform its laboratory developed test at
its Cypress, CA, laboratory two months ago, orders placed by physicians for
patients suspected of being infected with the 2009 H1N1 influenza virus
increased dramatically before peaking in late June. While test volume has
since declined, it remains more than 30 times higher than the company's
typical rate of influenza virus testing in July.
Of those samples tested by Focus Diagnostics, approximately three fourths
for patients between the ages of five and 20 years have tested positive for
the 2009 H1N1 influenza virus. By comparison, positivity rates in adults 21 to
40 years of age have averaged approximately 49 percent over the past two
months. Adults 41 to 60 years of age have experienced positivity rates of 36
percent, while those 61 to 80 years of age have experienced positivity rates
of approximately 14 percent.
"Our data are consistent with CDC data suggesting that this pandemic flu
virus is disproportionately affecting children and young adults, as compared
to older adults," Jay M. Lieberman, M.D., medical director, Focus Diagnostics,
said. "In fact, almost 60 percent of all positive results identified by our
test have been in children 18 or younger.
"In addition, our data, consistent with CDC data, reveal that not only has
this pandemic virus not faded away, it is behaving differently than the
seasonal flu, which is typically absent during the summer months in the
Northern Hemisphere," Dr. Lieberman continued. "When you also factor in the
rapid global spread of the virus, particularly the increasing number of cases
in certain countries in the Southern Hemisphere, it appears increasingly
likely that this novel H1N1 virus could be a major influenza strain
circulating in the U.S. this flu season."
Quest Diagnostics is currently in the process of validating the test at a
number of its CLIA high complexity laboratories around the U.S. capable of
performing the test in compliance with the emergency use authorization. The
Quest Diagnostics Focus laboratory in Cypress, CA, currently is the only
laboratory performing this test.
For more information about Quest Diagnostics and influenza testing
options, please visit www.QuestDiagnostics.com/2009H1N1 or www.FocusDx.com.
About the FDA's Emergency Use Authorization
The U.S. Secretary of Health and Human Services has declared a public
health emergency because of the outbreak of the pandemic flu virus. The FDA,
in response to requests from the CDC, has issued emergency use authorizations
to make important diagnostic and therapeutic tools available to public health
and medical personnel in order to identify and respond to the 2009 H1N1
influenza virus under certain circumstances.
The FDA has not cleared or approved any tests for the identification of
the 2009 H1N1 influenza virus. The emergency use authorization authority
allows the FDA, based on the evaluation of available data, to authorize the
use of unapproved or uncleared medical products or unapproved or uncleared
uses of approved or cleared medical products following a determination and
declaration of emergency, provided certain criteria are met. In the case of
the Influenza A H1N1 (2009) Real Time RT-PCR, the FDA has only authorized its
use for the duration of the declaration of emergency, which is currently set
to expire on April 26, 2010, unless it is terminated, revoked sooner or
renewed.
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 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.
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 one of the first FDA-cleared serological test kits for Lyme
disease.
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.
Contacts:
Wendy Bost (Media): 973-520-2800
Laure Park (Investors): 973-520-2900
SOURCE Quest Diagnostics Incorporated