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Reply | Forward Message #44 of 188 |
PANBIO's innovative diagnostic kit, the first immunoassay test to
achieve FDA commercial clearance will facilitate rapid reporting back
to medical practitioners and patients. A major breakthrough, the WNV
test answers the FDA's appeal to industry to develop a simple, cost-
effective test capable of large batch runs.

The announcement, the culmination of outstanding research and
development by PANBIO's scientific team, has far-reaching impact for
U.S. health authorities faced with increasing outbreaks of WNV and
responds to a critical healthcare need. Today's announcement is
timely, with experts predicting the incidence of infection from WNV
will rise in North America again this summer, largely as a result of
a wet spring and higher mosquito populations.

PANBIO Chief Executive Officer, Mr. Jim Porter, said the new
diagnostic test would play a pivotal role in the early detection of
WNV antibodies in people with suspected symptoms of the potentially
fatal disease.

He said the performance of the test has been proven in recent
clinical trials and has the advantage of providing results faster
than existing methods.

"FDA clearance allows us to meet an urgent demand for a swift,
reliable test and is a crucial step forward in combating this
disease," he said.

Mr. Carl Stubbings, Senior Vice President of PANBIO's U.S. operations
said FDA clearance of the new diagnostic test was important because
it would remove a bottleneck and broaden the base of testing allowing
clinical laboratories across the country to test for the disease.

He said last year clinical tests could only be conducted in a limited
number of major laboratories and state public health laboratories and
that due to widespread demand for WNV analysis, the major
laboratories were overwhelmed and reporting of results was slowed
nationwide.

Now, any accredited laboratory can buy the diagnostic kit and
significantly streamline the important process of analysis and
reporting. This swift turnaround has benefits too for the authorities
monitoring cases across the U.S. and Canada.

"The FDA's decision is great news for the fight against a growing
health threat, great news for people in high risk areas, and great
news for PANBIO as a company focused on responding to critical world
health needs," Mr. Stubbings said.

With operations in the U.S. and Australia, PANBIO has built a
reputation for world-class research and a track record of responding
first with high quality and easy to use diagnostic products for
infectious diseases.

The company was the first to develop and commercialize a test for
Ross River virus in Australia and first to develop commercial
diagnostic tests for dengue fever, a potentially fatal disease that
afflicts 100 million people annually in tropical regions of Asia and
South America. Like West Nile virus, Ross River and dengue viruses
are mosquito-borne diseases.

West Nile virus is a mosquito-borne disease that can cause life-
threatening illness in humans, horses and birds. It was first
detected in the United States in the fall of 1999 when 18 deaths were
recorded. Last year, 284 people died and 4,156 WNV positive cases
were reported to the Centers for Disease Control and Prevention
(CDC). About one in 150 people develop severe illness from WNV
infection, including potentially fatal meningitis and encephalitis
(swelling of the brain and lining around the brain). The very young,
the elderly and those with weakened immune systems face a higher risk
of severe illness from the infection.

For more information, please contact Ed Ellis, in Philadelphia, PA,
215-813-0086.





Fri Jul 25, 2003 2:55 am

eman_e_99
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PANBIO's innovative diagnostic kit, the first immunoassay test to achieve FDA commercial clearance will facilitate rapid reporting back to medical...
Eman
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Jul 25, 2003
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