FDA decision demolishes rapid tester’s share price

The FebriDx product was still an important tool for confirming a bacterial infection that would need antibiotics, he said.

“While this is very, very disappointing, I can also say we do feel as though it [the decision] based on the judgment of the FDA looking at in terms of the viral interpretation [of the test] instead of bacterial,” he said.

Lumos raised $63 million in an initial public offering in 2021 and hit the ASX boards in July. The stock stayed above the $1 per share mark until September, but has been on the decline since.

The business was spun out of health tech commercialisation company Planet Innovation, which takes technologies like the Lumos test and helps to bring these to market.

Planet Innovation was the largest shareholder in the company on listing, owning 26 per cent. The 40.1 million shares it held when Lumos hit the ASX boards would have been worth $46 million last July – and are worth $2.4 million today.

Ellerston Capital was also an early investor on the register, but no longer holds any of the stock. Planet Innovation declined to comment on its stake in the company.

“We are disappointed for all our shareholders, really,” Lanyon said.

However, he noted that there is a fundamental clinical need for a test that confirms a bacterial infection. Overuse of antibiotics is a factor in antimicrobial resistance, where diseases no longer respond to medicines, making them much harder to treat.

“There is a fundamental clinical need here. The appeals process is the next step,” he said.