Following its milestone CLIA waiver clearance for its FebriDx® rapid point-of-care test and the completion of a placement, Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) will conduct an investor presentation covering the two key updates.
LDX will host an investor webinar on Tuesday, March 31, 2026 at 9.00am AEDT, followed by a Q&A session.
Investors can pre-register for the webinar via the link provided by the company: https://us02web.zoom.us/webinar/register/WN_rgpFV6_mTI6SnayhDT80Hg
After completing registration, participants will receive a confirmation email with details on how to join the meeting.
Lumos wins US CLIA waiver for FebriDx, widening commercial opportunity
Lumos has secured a key US regulatory approval, with the Food and Drug Administration granting a CLIA waiver for its flagship FebriDx point-of-care test.
The milestone significantly broadens the settings in which FebriDx can be applyd, extconcludeing its reach across primary care and outpatient markets in the US.
The approval follows earlier 510(k) clearance and is expected to unlock US$5.5 million in milestone payments for the company while opening access to a much larger patient population and addressable market.
CLIA waiver broadens rollout
With the CLIA waiver now in place, FebriDx can be applyd at more than 300,000 healthcare sites across the US that operate under a Certificate of Waiver.
These include primary care clinics, urgent care centres, retail pharmacies and community health settings, materially expanding the product’s potential commercial footprint.
Lumos raises $20 million to back US FebriDx rollout
Lumos has also secured $20 million through a strongly supported institutional placement, with proceeds earmarked to expand manufacturing and commercial operations for its flagship FebriDx respiratory infection test in the United States.
The capital raising was announced alongside news that the US Food and Drug Administration had granted the Clinical Laboratory Improvement Amconcludements (CLIA) waiver for FebriDx.
The placement was priced at 22.5 cents a share and drew support from both existing and new institutional investors.
Lumos is seeking to raise a further $2 million through a share purchase plan, giving eligible shareholders in Australia and New Zealand the chance to acquire shares at the same price as institutional investors.
Separately, existing shareholders Tenmile and Ryder Capital have committed to exercise at least 43.9 million options, which is expected to deliver an additional $3.1 million in proceeds.
Leave a Reply