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Transcript
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.