H1N1 testing data presented at Infectious Diseases Society of
America conference
FLAGSTAFF, Ariz. - Oct. 29, 2009 - The Phoenix-based non-profit
Translational Genomics Research Institute (TGen) announced today
that, along with a business collaborator, it will submit a request
to the U.S. Food and Drug Administration for emergency use of a new
test to diagnose the 2009 H1N1 swine flu virus.
Details about TGen's test will be presented Sunday (Nov. 1) at the
47th annual meeting of the Infectious Diseases Society of America
(IDSA), being held today through Sunday (Oct. 29-Nov. 1) in
Philadelphia.
The new test, developed at TGen's Pathogen Genomics Division (TGen
North) in Flagstaff, can not only detect influenza - as some tests
do now - but also can quickly inform doctors about what strain of
flu it is and whether or not it may be resistant to oseltamivir
(sold under the brand name Tamiflu®; Roche), the primary anti-viral
drug on the market to treat H1N1.
As with other influenza strains, H1N1 flu can be expected to show
signs of resistance to oseltamivir, and new treatments will be
needed to respond to this and future pandemics.
"The problem with influenza is that it is becoming resistant to the
antiviral drugs that are out there,'' said Dr. Paul Keim, a
Professor of Biology at Northern Arizona University and Director of
TGen North. "Because it is a virus, it mutates easily and becomes
resistant.''
David Engelthaler, Director of Programs and Operations for TGen
North, said this would be the only resistance test available that
uses a standard molecular technique that rapidly makes exact copies
of specific components of H1N1's genetic material.
"So far, it looks like this assay is very effective with strains in
the U.S., and we expect it to have the same accuracy with strains
around the world,'' said Engelthaler, the former State
Epidemiologist for Arizona and former State of Arizona Biodefense
Coordinator.
The assay, or test, for H1N1 flu was developed by TGen and a
company called PathoGene LLC, which is a partnership that includes
a group of Flagstaff business people as well as Engelthaler and
Keim.
"We're very excited to work with TGen and the FDA to try to get
these tests out to the public. We think we can really help make a
difference," said William Gibbs, PathoGene's managing
partner.
PathoGene and TGen officials hope to secure emergency FDA approval
for the H1N1 flu test as soon as possible.
Currently, only the U.S. Centers for Disease Control Prevention
(CDC) and a few select labs can look for resistance, using
cumbersome and time intensive technology, Engelthaler said.
"This new test would put the power in the hands of the clinician to
determine if their drugs will work or not. This is really important
moving forward. When this outbreak first started (in April),
everything was 100 percent sensitive to Tamiflu. But now, we're
starting to see isolated cases of resistance pop up,'' Engelthaler
said.
The World Health Organization has identified more than three-dozen
instances of resistance to Tamiflu in the H1N1 swine flu
virus.
TGen also is working with a Bay Area pharmaceutical firm, Adamas
Pharmaceuticals, which is developing a unique triple-drug
combination to treat influenza and to impede resistance.
"TGen's diagnostic test has been a useful tool in our research and
is an important contribution to the influenza field," said Gregory
T. Went, Ph.D., Chief Executive Officer and Chairman of Adamas
Pharmaceuticals, headquartered in Emeryville, Calif.
At most doctors' offices, there is no readily available test for
H1N1 flu. Those tests are generally being done by state and federal
health agencies, and usually for those patients who require
hospitalization and appear at high risk because they have a
suppressed immune system or they have a chronic disease.
"The novelty in our study is the use of increasingly common
laboratory tools to rapidly and accurately detect resistance to
anti-influenza drugs. Until now, nearly all this work has required
highly sophisticated laboratory procedures not readily available to
most clinical labs and has really only been used for broad public
health surveillance,'' Engelthaler said. "Our testing procedure
measures very minute amounts of virus and minute changes to the
virus. Not only does it detect when resistance is occurring, but it
also detects it at the earliest onset possible."
*
About PathoGene LLC
PathoGene LLC is a for-profit company recently formed as a
partnership between successful investigators at TGen and proven
business leaders at Technical Resource Management (TRM), a private
firm that runs CLIA-certified laboratories. PathoGene promotes
early to late stage development of important molecular diagnostic
technologies for pathogenic microbes that have high impact on human
health and healthcare facilities. PathoGene is currently focused on
developing and commercializing molecular diagnostics for influenza
and antibiotic resistant organisms, such as Methicillin-resistant
Staphylococcus aureus, or MRSA, as well as the development of tools
to support drug development and public health surveillance. For
more information, visit: www.pathogene.com.
*
About TGen
The Translational Genomics Research Institute (TGen) is a
Phoenix-based non-profit organization dedicated to conducting
groundbreaking research with life changing results. Research at
TGen is focused on helping patients with diseases such as cancer,
neurological disorders and diabetes. TGen is on the cutting edge of
translational research where investigators are able to unravel the
genetic components of common and complex diseases. Working with
collaborators in the scientific and medical communities, TGen
believes it can make a substantial contribution to the efficiency
and effectiveness of the translational process. TGen is affiliated
with the Van Andel Research Institute in Grand Rapids, Michigan.
TGen's Pathogen Genomics Division (TGen North) is focused on the
study of many of the world's most dangerous infectious diseases.
TGen North shares many of its faculty with Northern Arizona
University in Flagstaff. For more information, visit:
www.tgen.org.
Press Contact:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
[email protected]