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PANBIO RECEIVES US - FDA CLEARANCE OF WEST NILE VIRUS TEST
Australian-based, international medical diagnostics company PANBIO Limited
today became the first company in the world to achieve United States Food and
Drug Administration (FDA) clearance for an immunoassay diagnostic kit to test
patients with suspected symptoms of the potentially fatal West Nile virus (WNV)
disease.
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.
PANBIO CEO, Mr Jim Porter, said FDA clearance for the diagnostic kit gave the
company a “first-to-market” advantage and was expected to boost sales revenue
for the company during the next 12 months by between $1.5 to $2 million in line
with the company’s forecast.
He said PANBIO had restructured its cost base, rationalised its product range,
expanded its U.S. sales capability and positioned itself for the launch of the WNV
product to ensure the company reached profitability this financial year and created
significant growth over the next three years.
“This announcement has far-reaching impact for U.S. health authorities faced with
the possibility of increasing outbreaks of WNV related to the unusually wet spring.
“It is the culmination of an outstanding collaboration across the company to drive
the development of a new product from concept to regulatory clearance in record
time,” he said.
Mr Porter said PANBIO’s innovative diagnostic kit was a major breakthrough which
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 new kit had been proven in recent clinical trials and
has the advantage of providing results faster than existing methods.
“FDA clearance of the new diagnostic kit is important because it will broaden the
base of testing allowing clinical laboratories across the country to test for the
disease,” he said.
Last year, it is estimated that over 500,000 people were tested for WNV in the
U.S., resulting in more than 4,100 positive cases being reported to the Centres for
Disease Control and Prevention (CDC). However, last year, the clinical tests could
only be conducted in a limited number of large “reference laboratories” and state
public health labs.
“Now any accredited laboratory can buy the diagnostic kit and significantly
streamline the process of analysis and reporting which will facilitate rapid reporting
back to the medical practitioner and patient.”
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 commercialise a test for Ross
River virus in Australia and first to develop commercial diagnostic kits 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.
Mr. Porter said the FDA’s decision was 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 growth.
He said PANBIO’s ability to develop and commercialise these products, along with
collaborative agreements with several research partners around the world, allowed
the company to compete successfully and aggressively on a global basis.