Lumos Diagnostics (ASX:LDX) Update

THE Milestones strengthen Ahead of the CLIA Decision

General advice only – prepared for Wholesale/Sophisticated/Professional Investors. See full disclaimers below.

Lumos Diagnostics (ASX:LDX) sits right at the intersection of a global healthcare problem and a simple, scalable solution.

Antibiotic resistance is one of the biggest threats to modern medicine. GPs are still handing out antibiotics like confetti. Not because they want to, but because it’s often the safest guess when they can’t tell if an infection’s bacterial or viral.

Lumos’ FebriDx test changes that equation. It’s a 10-minute, finger-prick test that gives doctors a clear answer on the spot. No fancy machines. Just results.

The potential market is enormous. If Lumos secures a US CLIA waiver, FebriDx will move from laboratories into 270,000 point-of-care clinics, unlocking a US$1 billion market and transforming how infections are diagnosed.

Crucially, Lumos already has a US$317 million distribution agreement with PHASE Scientific. The deal depends on CLIA waiver approval. If it isn’t granted, there’s still a guaranteed base of about US$25 million. Either way, Lumos secures meaningful minimum purchase commitments and a strong revenue base, with even greater upside if the waiver lands.

Over the past few months, Lumos has made serious progress toward that goal.

Key Developments Since Our Last Update

Aptatek Follow-On Contract (1 September 2025)

Lumos began the quarter by securing a US$1.5 million follow-on contract with Aptatek Biosciences to advance its in-home PKU monitoring device.

This deal expands Lumos’ service revenue base and showcases its growing reputation as a trusted development partner in rapid diagnostics, validation that the company’s expertise is in demand beyond FebriDx.

BARDA Paediatric Study (1 September 2025)

Soon after, the US government’s biomedical agency BARDA exercised its option to fund an additional US$6.2 million paediatric study.

This non-dilutive support extends FebriDx use to children aged 2–12, adding roughly 20% to the US market opportunity.
For investors, this marks further backing from a key US health authority and underscores confidence in Lumos’ technology and data.

YesGroup ANZ Distribution Deal (9 September 2025)

Lumos followed up with a second regional distribution agreement, signing YesGroup to complement existing partner Henry Schein.

This partnership strengthens local reach in Australia and New Zealand and builds early sales momentum ahead of the CLIA decision.

It reinforces Lumos’ ability to monetise FebriDx even before full US clearance.

Real-World Data From the UK (24 September 2025)

Later in the month, the NHS reported nearly two years of real-world FebriDx use. The data showed fewer antibiotics prescribed, fewer return visits, and measurable system cost savings.

This matters because it proves FebriDx not only works clinically but also drives economic efficiency. That's a powerful lever in future reimbursement negotiations. After all, the medical insurers are all about protecting their own hip pocket. So, funding for new treatments and diagnostics is often linked to the economic benefit to the insurer.

WellStreet Rollout Agreement (16 October 2025)

Most recently, Lumos announced its collaboration with WellStreet Urgent Care, a major US network partnered with Piedmont Healthcare in Atlanta.

Testing begins this month at one of WellStreet’s busiest clinics, expanding to around 140 locations nationwide if the CLIA waiver is granted.

This is Lumos’ first true step into real-world commercial deployment. It marks a massive indication of real demand in the market.

The Big Picture

From September through October, Lumos has ticked off milestone after milestone.

Between the Aptatek contract, BARDA’s funding, the YesGroup and WellStreet partnerships, and strong NHS validation, Lumos has evolved from a speculative biotech into a commercial stage diagnostics company with contracts, cash backing, and a clear growth pathway.

The demand for FebriDX is real, and a CLIA waiver could be a big deal.

In Summary

The big question on investors’ minds is whether or not the company has enough cash to see them through to the CLIA waiver decision.

The PHASE Scientific deal is a pivotal point in the Lumos Diagnostics (ASX:LDX) story.

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This publication has been prepared by The Markets IQ, a division of Vitti Capital Pty Ltd (ABN 13 670 030 145), which is a Corporate Authorised Representative (001306367) of Point Capital Group Pty Ltd (ABN 41 625 931 900), the holder of Australian Financial Services Licence 518031. This report is for general information only and does not take into account your objectives, financial situation, or needs. It is not personal financial advice or a recommendation to buy, hold, or sell any security. You should consider whether the information is appropriate in light of your circumstances and obtain professional advice before making any investment decision. This report is intended solely for wholesale, sophisticated, or professional investors within the meaning of the Corporations Act 2001 (Cth).

Any views, probabilities, valuations, technical levels, or forecasts expressed are strictly the opinions of the authors as at the date of publication, based on publicly available information and assumptions which may change without notice. They are illustrative only and not predictive of future outcomes. Past performance is not a reliable indicator of future performance.
Directors, staff, or clients of Vitti Capital may hold positions in Lumos Diagnostics (ASX:LDX) or related securities at the time of publication. Such holdings may change without notice. Vitti Capital applies internal controls to manage potential conflicts of interest; however, readers should assume that conflicts may exist.

The analyst(s) responsible for preparing this research note certify that the views expressed in this report accurately reflect their personal views about Lumos Diagnostics (ASX:LDX) and its securities. No part of their compensation is, or will be, directly or indirectly related to the specific recommendations or views expressed herein. The analyst(s) and/or their associates may hold an interest in Lumos Diagnostics (ASX:LDX).