First test for detecting the new virus to be authorized by FDA for use by CLIA
high-complexity labs during pandemic emergency
CYPRESS, Calif., Aug. 20 /PRNewswire-FirstCall/ -- Focus Diagnostics, the
infectious disease diagnostics business of Quest Diagnostics Incorporated
(NYSE: DGX), today announced that its Influenza A H1N1 (2009) Real Time RT-PCR
test is now available as a test kit for use by "high complexity" clinical
laboratories in the U.S. The test qualitatively detects the RNA of the 2009
H1N1 influenza virus ("pandemic virus") from a patient's nasal, nasopharyngeal
or throat specimen. In combination with clinical and epidemiological
assessments, the test aids physicians in diagnosing patients infected with the
pandemic virus rather than other influenza A strains.
"The availability of a quality test kit authorized by FDA for use during
the pandemic emergency will contribute to the nation's capacity for accurate
testing for the 2009 H1N1 influenza virus," said John Hurrell, Ph.D., vice
president and general manager, Focus Diagnostics. "Expanded testing for this
new virus could be critically important in aiding clinicians in determining
which influenza A virus is causing a patient's illness should there be a surge
in testing demand during the fall and winter flu season."
On July 24, the U.S. Food and Drug Administration ("FDA") announced it had
granted emergency use authorization ("EUA") to the Focus Diagnostics test, the
first granted to a commercial test for detecting the 2009 H1N1 influenza
virus. On August 17, FDA informed Focus Diagnostics that it had issued an
amended EUA for the company's test to reflect labeling clarifications
regarding the contents of the test kit. According to the EUA, the test may be
performed in laboratories certified under the U.S. Clinical Laboratory
Improvement Amendments ("CLIA") to perform high-complexity tests and operating
certain equipment.
In April 2009, the FDA granted two EUAs in connection with the CDC's
RT-PCR diagnostic panel used by public health labs in the U.S. to detect the
2009 H1N1 influenza virus infection. In its EUA application to the FDA, Focus
Diagnostics presented data involving more than 100 clinical specimens
indicating that the Focus Diagnostics test agreed 100% with the CDC's RT-PCR
test in identifying specimens as positive or negative for the pandemic virus.
For more information about Quest Diagnostics and influenza testing
options, please visit www.FocusDx.com or www.QuestDiagnostics.com/2009H1N1.
About the Influenza A H1N1 (2009) Real Time RT-PCR test
The Focus Diagnostics test uses reverse transcriptase polymerase chain
reaction, or RT-PCR, to amplify viral RNA to make it detectable in a specimen.
It targets two separate regions of the hemagglutinin ("H1") gene of the 2009
H1N1 influenza virus to differentiate the presence of the pandemic virus from
seasonal human influenza A virus. If RNA of Influenza A virus and the 2009
Influenza H1 gene are detected, the specimen is reported as positive for 2009
H1N1 influenza infection. The expected turnaround time for reporting a result
is within approximately 24 hours of receipt of a specimen by the Focus
Diagnostics laboratory in Cypress, California.
About the FDA's Emergency Use Authorization
The FDA has not cleared or approved any tests for the identification of
the 2009 H1N1 influenza virus. The EUA 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. Only CLIA high-complexity
laboratories operating certain equipment are permitted to perform the test
under the EUA.
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.
SOURCE Quest Diagnostics; Focus Diagnostics
CONTACT:
Media, Wendy Bost, +1-973-520-2800,
or investors, Laure Park,
+1-973-520-2900,
both for Quest Diagnostics