Panbio gets FDA approval for second-generation West Nile test

Panbio (ASX:PBO) has received approval from the FDA for an improved diagnostic immunoassay for West Nile Virus (WNV). The new test, which has increased specificity and sensitivity and is easier to use, comes a year after the company received approval for the first WNV test on the market.

Panbio CEO Jim Porter said the new test demonstrated the companies’ commitment to the MNV market, and raised the bar in terms of performance and ease of use. "It’s a fairly normal process when introducing a diagnostic test to continue to make improvements to it," Porter said.

The disease, which is found across Africa, Europe the Middle East, West and Central Asia and since 1999 in North America, is spread to human populations via birds and mosquitos. Almost 10,000 cases were reported in the US last year, and of these nearly 3000 were considered severe and 264 deaths were reported. As of August 10, 495 cases have been reported to the US Centres for Disease Control and Prevention, mainly in Colorado, Arizona and California. The season stretches from late July to mid-October.

"My sense is that it is a little early to say whether the incidence is higher or lower than last season, making it hard to predict demand," Porter said.

Porter noted that interest in the test was also increasing in Europe and the Middle East, where the disease is well established.