FDA Grants Clearance to PANBIO's Diagnostic Test for West Nile Virus.

Business Editors/Health/Medical Writers

WASHINGTON--(BUSINESS WIRE)--July 8, 2003

In a world-first, international medical diagnostics company PANBIO today received United States Food and Drug Administration (FDA) clearance for a diagnostic kit to test patients with suspected symptoms of the potentially fatal West Nile virus (WNV) disease.

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.