Panbio celebrates first FDA approval

In a first for the company, Panbio's diagnostic panel for glandular fever has been approved by the US Food and Drug Administration (FDA).

Mel Bridges, CEO of the Brisbane-based biotech, said Panbio already manufactured several products in its US facility for the US market.

"But this is the first one manufactured in our Australian plant, so it's a big milestone for us," he said.

Bridges said that as a result of the FDA approval, a good working relationship had developed between Panbio's Australian manufacturing facility and the FDA, which should help facilitate future approvals.

"The approval demonstrates that Panbio has in-house regulatory expertise which will allow it to lodge further FDA applications for existing products and new products currently under development," he said.

The diagnostic panel consists of three diagnostic marker blood tests for Epstein-Barr Virus (EBV), which causes glandular fever, primarily in teens and young adults.

EBV has also been implicated in several autoimmune diseases and causes complications in transplant patients.

The current market for EBV testing in the US is about $US10-20 million, Bridges said.

However, Panbio plans to develop a point-of-care test for use in doctors' offices, which will significantly expand the potential market, according to Bridges.

He said that having FDA approval on an existing test would give Panbio a strategic advantage in obtaining approval for the point-of-care test using comparative trials between the two formats to support the application.

The approval also will provide opportunities for Panbio to expand into the US diagnostics market, he said.