The Lumos Diagnostics Holdings Ltd (ASX: LDX) share price is going through the roof!
Shares in the ASX healthcare stock closed on Friday trading for 1.1 cents. At the time of writing, shares are swapping hands for 12.5 cents.
Shares gained 564% in Monday trade. And they're up another 71% in morning trade today.
That sees the Lumos Diagnostics up a stellar 1,036% in less than two days of trading!
This comes after Lumos, which develops and sells point-of-care diagnostic (POC) tests, reported it had received clearance from the United States Food and Drug Administration (FDA) for one of its core products.
Here are the highlights.
What's happening with the FDA?
Investors are bidding up the Lumos Diagnostics share price after the company received FDA clearance to market its FebriDx rapid, point-of-care test in the US.
FebriDx can now be marketed in the world's top economy to assist healthcare professionals in diagnosing bacterial acute respiratory infections and differentiating this from non-bacterial etiology in urgent care and emergency situations.
FebriDx is already registered in the United Kingdom, Europe, Canada, the United Arab Emirates, Brazil, Turkey, Pakistan, Singapore, Malaysia and Australia.
Lumos Diagnostics noted FebriDx can help combat the overuse of antibiotics, which is contributing to resistant strains of bacteria. The company said most acute respiratory infections are viral in origin, yet antibiotics are commonly prescribed. Up to 40% of these prescriptions are considered unnecessary.
Commenting on the FDA approval sending the Lumos Diagnostics share price rocketing, CEO Doug Ward said, "We are delighted to finally secure clearance to market our FebriDx rapid, point-of-care test in the US as we continue to believe it has an important role to play in antibiotic stewardship."
Ward added:
With this clearance in hand, we anticipate securing our first commercial orders in the US before the end of calendar year 2023. In the meantime, we are continuing to work with distribution partners and potential licensees, as well as establish our own focused sales effort, as we prepare to launch FebriDx in the US.
How has the Lumos Diagnostics share price performed longer term?
While you won't hear any recent investors complaining following this week's surge, the Lumos Diagnostics share price remains down 17% over the past 12 months.
The ASX healthcare share has gained 160% in 2023.
