Panbio scores FDA approval, world first

Bribane diagnostic biotech Panbio has become the first company ever to rate US FDA approval for a West Nile virus (WNV) immunoassay diagnostic kit.

Panbio CEO Jim 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 his company’s growth.

“There was clearly a need for this kind of test, so we threw our experience in vector and mosquito-borne diseases into the area,” said Porter. “This is the culmination of an outstanding collaboration across the company . . . . . it was a remarkable achievement,” he said.

The presumptive test, which identifies the presence of viral antibodies in a sample taken from the patient, can be undertaken by much smaller laboratories than previously, with a corresponding cut in both time and costs. The results can then be used to alert doctors of possible infection.

“Previous tests could only be undertaken by one of the 12 to 15 FDA-approved reference labs across the US, and could take up to two or three days. Using our test, standard accredited clinical labs – and there are around 2 to 3000 of them -- can do the test and come up with a result in as little as three hours.

“Not only that, our tests will only cost about $6 per test at the laboratory. That is dramatically cheaper than before,” he added.

WNV has been tipped to increase its spread this year thanks to an unusually wet spring, so the advent of the new test has been timely, and welcomed by regulators and industry alike, said Porter.

“So the fact it is quicker and easier are good reasons why everybody wanted to get the test to market as quickly as possible,” said Porter. “The FDA approval will give Panbio a “first-to-market” advantage which could boost sales revenue by up to $2 million during the next 12 months,” he added.

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.

Porter hinted that the company was working on two or three similar first-strike diagnostics, also in the areas of vector-borne disease, the first of which could be available as soon as the end of this year.

“It is too soon to disclose the new targets we have, but we are working on producing two or three within the coming years. There is a massive unmet need for diagnostics in animal and mosquito borne disease. We can help save lives; it is a really big opportunity,” asserted Porter.