FDA Issues Another Emergency Use Authorization for Commercial H1N1 Flu Test to Quest Diagnostics' Focus Diagnostics
The U.S. Food and Drug Administration issued a second
emergency use authorization to Focus Diagnostics, the infectious
disease diagnostics business of Quest Diagnostics Incorporated,
for its 2009 H1N1 influenza virus test. With the EUA, Focus Diagnostics
is the only company in the U.S. to offer test kits for detecting the
pandemic 2009 H1N1 virus that the FDA has authorized for emergency use
by CLIA high-complexity labs, which include certain hospital and
regional labs. The test allows clinicians to quickly and definitively
identify infected patients, differentiating from those who have similar
symptoms.
The new EUA
authorizes Focus Diagnostics to market and offer its Simplexa(TM)
Influenza A H1N1 (2009) test for use on the 3M(TM) Integrated Cycler
from 3M
to CLIA high complexity laboratories for the duration of the emergency.
The 3M Integrated Cycler is a microfluidic molecular diagnostic testing
system and is not FDA cleared or approved. Used on the 3M platform, the
test can provide increased capacity for 2009 H1N1 influenza virus
testing to a wide range of CLIA-high complexity laboratories, including
many hospitals, coping with a surge in testing demand.
The
new test offering is one outgrowth of an exclusive global distribution
agreement formed between Focus Diagnostics and 3M under which Focus
will develop and offer its first line of molecular diagnostic test
kits, to be sold under the Simplexa brand name, on the 3M Integrated
Cycler. The 2009 H1N1 influenza test kit is the first offering from the
Simplexa product line, and the company plans to launch additional
Simplexa test kits on the 3M Integrated Cycler for infectious diseases
in 2010.
"FDA's EUA for
our new Simplexa H1N1 test on the 3M Integrated Cycler is a major
advance for 2009 H1N1 influenza testing," said Jon R. Cohen, M.D.,
senior vice president and chief medical officer, Quest Diagnostics.
"Until now, many CLIA-high complexity labs didn't have the technology,
space or expertise to perform molecular testing for the 2009 H1N1 flu
virus. Our relationship with 3M means that not only will more labs be
able to perform this type of testing, but they will also be able to
fulfill higher levels of testing demand. Expanded lab capability may be
critical to the nation's management of increased 2009 H1N1 testing this
winter."
"Our
exceptional collaboration with Focus Diagnostics underscores 3M's
commitment to leading the industry in introducing new technologies in
clinical diagnostics," said Debra Rectenwald, vice president, general
manager, 3M Infection Prevention Division. "We are excited that Focus
Diagnostics will be able to implement a real-time molecular technology
that can improve the speed and meet the demand for H1N1 testing."
Quest
Diagnostics' Focus Diagnostics has a track record of being first to
market with new laboratory testing services for emerging infectious
diseases. On July 24, 2009, FDA announced that it had issued its first
emergency use authorization for a commercial 2009 H1N1 influenza virus
test to Focus Diagnostics for a laboratory developed test it had
launched in May 2009. This EUA was issued for the test running on
equipment from Roche and Applied Biosystems.
The
Focus Diagnostics Simplexa(TM) Influenza A H1N1 (2009) test, which
employs real-time polymerase chain reaction (PCR), qualitatively
detects RNA of the 2009 H1N1 flu virus in a patient's nasal or
nasopharyngeal specimens. The test targets a separate region of the
hemagglutinin gene of the 2009 H1N1 influenza virus to differentiate
the presence of the 2009 H1N1 flu virus from seasonal human influenza A
virus.
The 3M
Integrated Cycler is an instrument offering real-time polymerase chain
reaction (PCR) technology that provides results in 30-75 minutes. The
compact instrument utilizes advanced data management software to help
laboratories process, store and transfer data quickly and effectively.
In addition, the instrument has a small laboratory footprint at
approximately 12 inches high and 12 inches deep, and can process up to
96 samples per run.
"Our
reference laboratories typically report results within 24 hours of
receipt of specimen," said John G. Hurrell, PhD, vice president and
general manager, Focus Diagnostics. "With the Simplexa test on the 3M
Integrated Cycler, a typical CLIA high-complexity laboratory can
generate results within hours, considerably reducing time spent to send
a specimen to an outside lab. Faster turnaround time can aid in
clinical management of the patient and allow hospitals to segregate
infected patients from other high-risk individuals."