FDA clears PanBio's West Nile assay

Panbio (ASX:PBO) has received US Food and Drug Administration clearance for its West Nile virus IgG diagnostic assay, and appointed former Woolworths and Elders IXL manager John Lee as a non-executive director and chairman of the company's board.

Panbio CEO Jim Porter said Lee would bring experience in strategic and operational planning, investor relations and corporate governance to the company. Lee replaces Tim Bosher, who has retired as chairman, but will remain on the Panbio board as a non-executive director.

The IgG test approval follows the approval of of Panbio's IgM immunoassay for West Nile virus in July last year. A second generation version of the IgM test was approved two months ago.

Porter explained that the IgG and IgM assays would ideally be conducted at the same time. "A significant proportion of the time they are used together," he said.

Physicians can use the IgM assay to test for an acute current infection, and the IgG test to tell whether the patient has had the disease sometime in the past. "This is a complementary test," said Porter. "It broadens our suite of products."

Panbio markets the tests directly to doctors in the US through a small sales team associated with its US subsidiary.

Porter said that although Panbio was the first company to introduce a West Nile virus diagnostic last year and to have it cleared by the FDA, a competitor had launched a diagnostic onto the market at the end of last year. "Fundamentally, we compete with another company, but we also compete with in-house tests developed by the public health labs," he said. "It is a market that is not yet fully defined, but we have a significant share and it is growing."

He said the rate of West Nile virus cases was down this year compared to the previous year due to factors including climate, rainfall, the propensity of mosquitos to breed, and the levels of disease in the human and bird populations.