CYPRESS, Calif. and
MADISON, N.J., Oct. 6, 2015 /PRNewswire/ -- In advance of
the 2015-2016 flu season, Focus Diagnostics, the products business
of Quest Diagnostics (NYSE: DGX), today announced that its
Simplexa™ Flu A/B & RSV Direct Kit has received
510(k) clearance from the U.S. Food and Drug Administration (FDA)
for 46 additional influenza A and influenza B virus strains and 7
additional respiratory syncytial virus (RSV) strains.
The FDA granted 510(k) initial clearance to the Simplexa test
kit for select virus strains in July
2012 and clearance of some additional strains in 2014. With
the recent clearance, the Simplexa test can detect a total of 92
influenza and RSV virus strains, more than any other FDA-cleared
molecular test kit. These include all four influenza strains the
World Health Organization recommends be included in vaccines during
the northern hemisphere's 2015-2016 influenza season:
A/Switzerland/9715293/2013
(H3N2)-like virus; A/California/7/2009 (H1N1)-like virus,
B/Phuket/3073/2013-like virus and
B/Brisbane/60/2008-like virus.
In addition, the 46 new influenza strains include 20 avian
influenza A and two swine influenza virus strains. These may be
increasingly important to detect, as avian and swine influenza
viruses can carry over into human populations.
"With the influenza virus constantly evolving year after year
and the potential to infect large populations, it's critical that
physicians have access to tests to aid the detection of newly
circulating and geographically diverse strains," said Michelle Tabb, PhD, vice president of research
and development for Focus Diagnostics. "We are particularly
gratified that we have validated recently circulating influenza
viruses – including the Switzerland, California, Phuket and Brisbane strains – before this year's flu
season takes off, and that we have expanded our avian influenza
detection claims."
Influenza occurs globally, affecting an estimated 5%-10% of
adults and 20%-30% of children, according to the World Health
Organization statistics. According to the Centers for Disease
Control and Prevention (CDC), most seasonal flu activity in the
Northern Hemisphere occurs between October and May, with peak
season in the United States
between December and February.
The Simplexa Flu A/B & RSV Direct kit on the 3M Integrated
Cycler is a real-time RT-PCR molecular test for the in vitro
qualitative detection and differentiation of influenza A virus,
influenza B virus and respiratory syncytial virus (RSV) RNA in
nasopharyngeal swabs from patients with signs and symptoms of
respiratory tract infection in conjunction with clinical and
epidemiological risk factors. It was one of the first tests to be
FDA cleared for combined molecular detection of influenza A, B and
respiratory syncytial virus. Classified as CLIA moderate
complexity, the test can report results in about an hour through a
proprietary process that eliminates nucleic acid extraction, a time
consuming technique typically employed by molecular tests.
About Focus Diagnostics and Simplexa™
Focus
Diagnostics, Inc., a business of Quest Diagnostics, develops and
manufactures the Simplexa line of molecular test products operating
on the Integrated Cycler, a compact, portable testing platform, as
part of a global collaboration with 3M. Simplexa was the first test
kit to be FDA cleared for aiding in the detection and
differentiation of the 2009 H1N1 influenza virus in May 2010. Additional Simplexa tests aid in the
detection and differentiation of influenza A, influenza B and RSV,
Clostridium difficile, Group A Strep and HSV 1 & 2. The
Simplexa/3M technology has won several industry awards for medical
innovation, including winning the prestigious Gold-level Medical
Design Excellence Award and Bronze level Edison award. In addition
to Simplexa, Focus Diagnostics' products sold worldwide include
HerpeSelect™ type-specific HSV serology and West Nile Virus
DxSelect™. To learn more or to order Simplexa and other Focus
Diagnostics tests, please contact Focus Diagnostics at 800-838-4548
or visit www.focusdx.com.
About Quest Diagnostics
Quest Diagnostics empowers
people to take action to improve health outcomes. Derived
from the world's largest database of clinical lab results, our
diagnostic insights reveal new avenues to identify and treat
disease, inspire healthy behaviors and improve health care
management. Quest annually serves one in three adult
Americans and half the physicians and hospitals in the
United States, and our 45,000
employees understand that, in the right hands and with the right
context, our diagnostic insights can inspire actions that transform
lives. www.QuestDiagnostics.com.
About 3M
3M is a science-based company with a culture
of creative collaboration that inspires powerful technologies,
making life better. With $32 billion
in sales, 3M employs 90,000 people worldwide and has operations in
more than 70 countries. For more information, visit www.3M.com or
follow @3MNewsroom on Twitter.
Quest, Quest Diagnostics, any associated logos, and all
associated Quest Diagnostics registered or unregistered trademarks
are the property of Quest Diagnostics. All third-party marks are
the property of their respective owners.
Contacts:
Wendy Bost,
Quest Diagnostics (Media): 973-520-2800
Dan Haemmerle, Quest Diagnostics
(Investors): 973-520-2900
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