Lumos Diagnostics (ASX: LDX) - The FebriDx Test, the Evidence and the US Rollout
Lumos Diagnostics (ASX: LDX) makes FebriDx, a 10-minute finger-prick test that helps a doctor tell a bacterial respiratory infection from one that is not. It is cleared for use in ordinary US clinics, it has a US distributor, and Lumos reports it in use at 215 US sites. Most of the US$317 million distribution agreement depends on future orders, and the accounts carry a going concern note. This Insight reads the trial evidence, the agreement and the cash.
Lumos Diagnostics is an ASX-listed company, registered in Melbourne, that makes rapid tests in Carlsbad, California. Its main product is FebriDx. A nurse pricks the patient's finger and the test reads two proteins in the blood. About 10 minutes later, coloured lines show whether the patient's immune response looks like a bacterial infection. The result is an aid that helps the doctor decide whether an antibiotic is likely to help.
Lumos was one of four companies that presented at the biotech and healthcare webinar "The Infection Playbook", run by the financial services firm MST in October 2026. Samso is writing an Insight on each of them.
All prices in this piece are as at the close of ASX trading on 21 October 2026.
WHAT THIS PIECE COVERS 1.00 LUMOS DIAGNOSTICS IN OCTOBER 2026 Who Lumos is, what it owns, its cash and its share register. 2.00 THE PROBLEM FEBRIDX IS BUILT FOR Why doctors give antibiotics to people with viral infections, and how often. 3.00 HOW THE FEBRIDX TEST WORKS MxA and CRP, what each one signals, and how the result is read. 4.00 WHAT THE TRIAL EVIDENCE SAYS The US trial behind the test, what each accuracy figure means, and its limits. What the March 2026 FDA decision allows, and the study behind it. The Medicare rate, the claims data and who takes a margin along the way. 7.00 THE PHASE SCIENTIFIC AGREEMENT What has been paid, what depends on future orders, and how the wording has changed. Live sites, sites in evaluation, and the flu season ahead. FY26 revenue by type, the cash, the auditor's note and the share price. The paediatric study, the Carlsbad build-out and the dates to watch. 11.00 THE OTHER SIDE OF THE CASE Clinical, commercial and financial risks in one place. |
HOW TO USE THIS PIECE Medical and regulatory terms are explained where they first appear. All of them are also collected in one box at the back, just above the references. Every source carries an identifier, [R1] to [R32]. The same identifier appears in the text where the source is used, so each number can be traced to the document behind it. Where the company's documents give two different figures for the same thing, this article quotes both as they were published and names the document each came from. Where the article builds its own model from released data, it says so at that point and labels it as a theoretical model. |
1.00 — LUMOS DIAGNOSTICS IN OCTOBER 2026
Two businesses, with FebriDx as the main product
Lumos Diagnostics Holdings Limited (ASX: LDX) has two businesses. The products business makes and sells Lumos-branded tests, and FebriDx is by far the largest of them. The services business designs and builds rapid tests for other companies. One is Hologic, which is paying Lumos to develop the next version of Hologic's test for the risk of premature birth [R14].
The company is registered in Melbourne. Its laboratories and factory are in Carlsbad, California, north of San Diego (FIG. 01). Lumos reports in US dollars because most of its revenue and most of its costs are in US dollars [R14].
At 30 June 2026 Lumos held US$15.4 million in cash and had no debt [R11]. FY26 revenue was US$13.2 million, of which US$3.92 million came from FebriDx [R14]. The year ended with a net loss of US$5.0 million [R13]. The result includes a one-off, non-cash gain of US$6.8 million from reversing an earlier write-down of Lumos's intellectual property. It also includes a non-cash cost of US$3.8 million for share-based pay. Lumos reports an adjusted EBITDA loss of US$2.8 million [R13]. Without that one-off gain, the reported loss would have been larger.
There were 988,166,270 shares on issue on 20 October 2026 [R23]. At the closing price of 8.8 cents on 21 October 2026, Lumos had a market value of about A$87 million, on Samso's arithmetic. In March and April 2026 the company raised A$20.0 million from institutions at 22.5 cents a share, and a further A$0.3 million from existing holders through a share purchase plan [R7] [R13]. Every two new shares came with one free option to buy another share at 34 cents before the end of 2027 [R7].
Two investors hold more than a third of the company. Tenmile Ventures is the largest shareholder, with 187,270,660 shares or 19.82 per cent [R14]. That figure is from the annual report's substantial holder table, which the report says is drawn from the April 2026 prospectus and later substantial holder notices. Its representative, Aizaz Syed, joined the board on 12 October 2026 [R21]. Ryder Capital lifted its holding to 161,671,446 shares, or 16.65 per cent, on 15 September 2026 by exercising options at 7 cents [R22]. Both also lent the company money in 2025. That money has since been repaid [R11].
The annual report's substantial holder table and Ryder's notice give different figures for Ryder's earlier holding. The annual report shows 135,985,593 shares and 14.39 per cent [R14]. Ryder's notice of 15 September 2026 gives the same holding as 135,895,593 shares and 14.73 per cent [R22]. Both are quoted here as released.
2.00 — THE PROBLEM FEBRIDX IS BUILT FOR
Antibiotics prescribed for infections they cannot treat
A cough, a sore throat, a blocked nose and a fever are signs of what doctors call an acute respiratory infection, or ARI. Acute means it came on recently. ARIs are the most common infectious illnesses, and they account for more than 150 million visits to US outpatient clinics a year [R2]. Most are caused by viruses, such as influenza, COVID-19 and the common cold. A smaller share are caused by bacteria, such as the streptococcus behind strep throat.
Antibiotics kill bacteria and do nothing against a virus. A patient with a viral infection gains nothing from an antibiotic and can still get its side effects. Across a whole population, every unnecessary course adds to antimicrobial resistance, which is when bacteria stop responding to antibiotics.
A bacterial and a viral infection often look the same in the consulting room (PLATE 01) [R29]. So a doctor with a busy clinic and a feverish patient often prescribes an antibiotic as a precaution [R14]. The US Centers for Disease Control and Prevention (CDC) says at least 28 per cent of antibiotic prescriptions written in US doctors' offices and emergency departments are unnecessary [R20].
Lumos uses different figures in its presentations. Its July 2026 deck says 44 per cent of US outpatient antibiotic prescriptions are written for ARIs, citing a 2016 study. It says 40 per cent of those are unnecessary, citing a 2022 paper in the journal Antibiotics by Tse, Near and others [R12]. These measure a different thing from the CDC's 28 per cent, which covers all conditions. Samso quotes the CDC figure as the reference point because it is the US government's estimate.
FebriDx is built for that decision in the consulting room. It reads how the patient's immune system is responding, and gives a result while the patient is still there. Identifying the bacterium or virus itself needs a separate test.
3.00 — HOW THE FEBRIDX TEST WORKS
Two proteins, one drop of blood, 10 minutes
FebriDx is a single plastic cassette with a retractable needle built into one end (PLATE 02). It needs no machine to read it [R1]. The US Food and Drug Administration (FDA) describes it as a rapid immunoassay that uses lateral flow [R3]. That means a liquid sample soaks along a paper strip, and antibodies printed on the strip catch particular proteins and show them as a coloured line. A home COVID test works the same way.
The first is MxA, short for myxovirus resistance protein A. White blood cells make MxA when the body detects a virus. It rises with many common viruses, including influenza and SARS-CoV-2, the virus that causes COVID-19, and it stays low in most bacterial infections. A high MxA reading points to a virus [R2].
The second is CRP, short for C-reactive protein. The liver makes CRP whenever the body is inflamed. It rises with bacterial infections, and it can also rise with some viral infections. On its own, a high CRP tells a doctor that something is going on, but not what [R2].
The test reads CRP as raised from 20 milligrams per litre and MxA from 40 nanograms per millilitre [R2].
FebriDx reads both at once. FIG. 02 is the company's diagram of the procedure and the result window. A black line alone means CRP is raised and MxA is not, which is the pattern of a bacterial infection. A red line means MxA is raised, with or without CRP, and the company presents this as the pattern of a virus. A blue line confirms the test ran properly [R1].
The US label sorts the result into two groups [R3]. A black line alone is read as "bacterial". A red line, or no result line at all, is read as "non-bacterial". This wording is narrower than the company slide in FIG. 02, which labels the red-line results as viral. The label describes the result as an aid to the doctor, to be read with everything else the doctor knows. It also says the test does not identify a particular organism or measure how sick the patient is [R3].
Lumos describes FebriDx as working alongside the rapid tests for influenza and COVID-19 [R25]. Those tests look for the virus itself. A clinic that wants to know which virus a patient has uses one of them as well.
4.00 — WHAT THE TRIAL EVIDENCE SAYS
The DISRUPT trial and how accurate FebriDx was
The evidence for FebriDx in the United States comes from one main trial, called DISRUPT. It enrolled patients between October 2019 and April 2021 at 20 sites across the country. These were nine emergency departments, six urgent care clinics, which are walk-in clinics for problems that need attention the same day, and five primary care clinics [R2]. Lumos paid for the study and supplied the tests. The paper says the funder had no role in the design, the analysis or the decision to publish. Three of the 15 authors worked in Lumos's medical affairs team and are listed as contributing to the concept and design. Two authors reported Lumos stock options. One of them also reported a Lumos patent issued and a second pending [R2].
The results were published in JAMA Network Open, a peer-reviewed journal of the American Medical Association, on 18 October 2022, under the lead authorship of Dr Nathan Shapiro of Beth Israel Deaconess Medical Center in Boston [R2]. The same data supported the FDA's first clearance of FebriDx, K230917, on 30 June 2023 [R1].
How the trial decided which infections were bacterial
In diagnostics we measure a new test against a gold standard, which is the most reliable test already available. For a bacterial respiratory infection there is no single gold standard, so DISRUPT built a reference method from several tests. Each patient had swabs and blood taken and sent to central laboratories, which tested for 28 pathogens and for markers such as procalcitonin, a blood protein that rises in many bacterial infections. An algorithm combined the results, and two independent doctors reviewed each case and could overrule it [R2]. That final call is the "reference result" FebriDx was measured against.
The reference result used blood markers of the immune response as well as tests for the organisms [R1]. FebriDx also reads the immune response, so the two are partly measuring the same thing. The authors note that some patients may have been misclassified [R2]. That overlap may make FebriDx's figures look better than a comparison with tests for the organism alone would show. That is Samso's reading. The paper does not measure it.
Of 520 patients with a respiratory infection, 24 could not be classified because samples were lost or damaged in transit. That left 496. The reference panel classed 73 of them, or 14.7 per cent, as bacterial. It classed 296 as viral and 127 as having no infection it could detect [R2].
Sensitivity, specificity and the two predictive values
In diagnostics we judge a test on four numbers. Each answers a different question, and FIG. 03 shows where they come from.
Sensitivity asks how many of the truly bacterial patients the test caught. FebriDx flagged 68 of the 73, or 93.2 per cent, and missed five [R2].
In the 33 bacterial patients where a laboratory confirmed the bacterium, the test caught all 33 [R2]. That is a small group, so the uncertainty around the figure is wide.
Specificity asks how many of the non-bacterial patients the test correctly left alone. FebriDx read 374 of 423 as non-bacterial, or 88.4 per cent. The other 49 were flagged as bacterial when the reference panel said they were not [R2].
Negative predictive value (NPV) looks at it from the doctor's side. When the test says non-bacterial, how often is that right? In DISRUPT it was right 374 times out of 379, or 98.7 per cent, with a 95 per cent confidence range of 96.9 to 99.4 per cent [R2]. This is the figure behind the test's main use, which is ruling a bacterial infection out. The company's July 2026 deck describes it as more than 99 per cent accuracy for ruling out bacterial infection, and elsewhere as a 99 per cent NPV [R12]. The trial paper reports 98.7 per cent [R2].
Positive predictive value (PPV) asks the opposite. When the test says bacterial, how often is that right? In DISRUPT it was right 68 times out of 117, or 58.1 per cent [R2]. A little over four in ten bacterial results were for patients the reference panel did not class as bacterial.
FebriDx is therefore most reliable when it reads non-bacterial, which tells a doctor that antibiotics are unlikely to help. A bacterial result was right a little under six times in ten. The authors write that the test should be used to aid clinical judgement rather than replace it [R2].
Why the same test gives different figures in a different clinic
Predictive values move with the share of patients who really are bacterial. DISRUPT had 14.7 per cent. A clinic that sees sicker patients is likely to have more. A clinic in the middle of a flu season may have fewer.
FIG. 04 is a theoretical model. Samso took the trial's sensitivity and specificity as fixed and calculated what the two predictive values would be at other shares of bacterial patients. At 14.7 per cent the model gives the trial's results back, 98.7 per cent and 58.1 per cent. At 30 per cent, the NPV falls to 96.8 per cent and the PPV rises to 77.5 per cent. The more bacterial patients a clinic sees, the more often a bacterial result is right, and the slightly less often a non-bacterial result is right. The model holds the test's performance fixed in every population, and real tests usually shift a little from one population to the next. It shows which way the two figures move.
Prescribing in the trial, and the patients it left out
The trial also looked at what doctors actually prescribed, without seeing the FebriDx result. Of the 423 non-bacterial patients, 78 received antibiotics. Of the 73 bacterial patients, 28 did not. The paper estimates that prescribing in line with the test would have cut the first number from 78 to 49 and the second from 28 to 5 [R2]. This is the paper's calculation from the trial data. The doctors in the trial did not see the FebriDx result, so the effect on prescribing has to be measured in daily use.
Most DISRUPT patients were under 65. Patients over 65 made up 7.5 per cent of those enrolled, and the trial did not include people with weak immune systems or anyone who had taken antibiotics in the previous two weeks. The authors write that the test's performance in those groups is undefined [R2]. The FDA summary says performance has not been established in patients younger than 12 or older than 64, and the test should not be used in those groups [R1].
Evidence from use in practice
Lumos's data on prescribing in daily use so far comes from England. In September 2025 Lumos released a poster from the NHS in Calderdale, West Yorkshire, where the test had been used in respiratory infection hubs in primary care from 2023 (FIG. 01) [R19]. The poster reports that an earlier evaluation found the test changed the prescribing decision in 45 per cent of cases, and that 85 per cent of 326 surveyed patients who had the test found it useful [R19]. That is early evidence, from a survey reported in a conference poster.
In the United States, Lumos's annual report quotes WellStreet's senior medical officer as saying antibiotic prescribing fell at the pilot site. It does not give a number [R14].
5.00 — THE CLIA WAIVER
What the CLIA waiver changed about where FebriDx can be used
The FDA first cleared FebriDx in June 2023, under 510(k) number K230917 [R1]. A 510(k) is an FDA path to market for a medium-risk medical device. The company shows the device is as safe and effective as one already on the market, and the FDA calls it "substantially equivalent".
That first clearance came with a limit. In the United States, laboratory tests are sorted by how hard they are to run, under a law called the Clinical Laboratory Improvement Amendments, or CLIA. FebriDx was classed as moderate complexity. It could only be used at sites certified for moderate-complexity testing, by staff qualified to run it. The 2023 label named urgent care and emergency settings [R1]. Lumos says this kept it mainly in hospital and laboratory settings [R6].
A CLIA waiver removes that limit. A waived test is judged simple enough to be run by ordinary clinic staff, such as a nurse or a medical assistant, in any clinic that holds a Certificate of Waiver. Lumos says this opens FebriDx to primary care offices, urgent care clinics, retail and pharmacy clinics and community health centres that hold that certificate. It puts the number of such locations at more than 300,000, citing the US Centers for Medicare and Medicaid Services (CMS) database of March 2024 [R6]. The 2026 label also dropped the earlier wording that named urgent care and emergency settings [R3].
For Lumos that means FebriDx can now be sold to clinics that hold only a Certificate of Waiver.
The decision and its dates
The FDA's database records the decision on the new 510(k), K260787, as dated 24 March 2026. It was a dual submission, which asks for clearance and a CLIA waiver together [R3]. The CMS fee schedule lists the waived version of the FebriDx billing code as effective from the same day [R4]. Lumos announced the waiver on 27 March 2026 [R6]. Its later documents date the waiver to 27 March 2026 [R11]. That is the date of the company's announcement in Australia, three days after the FDA decision date.
The study behind the waiver
To obtain the waiver, Lumos had to show that untrained staff get the same result as trained laboratory staff. The study ran from December 2024 to July 2025 at nine US clinics, including doctors' offices, primary care clinics and urgent care centres. At each clinic, an untrained operator and a trained operator each pricked the same patient's finger and ran a test, in separate spaces, without seeing each other's result [R3].
FIG. 05 shows the result in the FDA's Table 5. Across 595 paired tests, the two operators agreed on 106 of the 107 tests the trained operator read as bacterial. That is 99.1 per cent, which the FDA calls "positive percent agreement". They agreed on 480 of the 488 the trained operator read as non-bacterial. That is 98.4 per cent, which the FDA calls "negative percent agreement" [R3].
These two figures show that clinic staff and laboratory staff read the test the same way. Accuracy against the infection itself comes from DISRUPT, and the FDA summary refers back to the 2023 clearance for it [R3]. Lumos describes the waiver study as showing "99%+ concordance", which is this agreement figure [R12].
Some tests gave an invalid result the first time, and all of them worked on a second attempt [R3]. The annual report gives the number of study sites as six, against nine in the FDA summary [R14].
6.00 — WHO PAYS FOR THE TEST
The billing code and the money chain
In the United States a clinic buys the test, uses it on a patient and then bills the patient's insurer. For that to work, the test needs a billing code and a price that insurers recognise.
FebriDx has its own billing code, 0442U. It is a Proprietary Laboratory Analyses (PLA) code, which is a code issued for one company's branded test. The CMS Clinical Laboratory Fee Schedule for the fourth quarter of 2026 lists 0442U at US$41.38 a test. It carries a second line with the QW modifier, which is the marker for a CLIA-waived test, effective from 24 March 2026 [R4].
Medicare, the US government's insurance for people aged 65 and over and some younger people with a disability or kidney failure, is run through twelve regions by seven Medicare Administrative Contractors, or MACs. FIG. 06 is the map from Lumos's announcement of 21 November 2025, when the last of the seven recognised the FebriDx code [R10]. Lumos says Medicare is about 20 to 24 per cent of the US payer mix [R10]. The Medicare rate reaches beyond Medicare patients. Lumos says Medicare Advantage plans, which are private plans that provide Medicare cover, and Medicaid, the US insurance for people on low incomes, often refer to the Medicare fee schedule [R10]. The annual report says Medicare often sets a precedent for private insurers [R14]. That reach is useful for FebriDx because most Medicare patients are 65 or older, which is outside the test's label.
The annual report describes the Medicare position in two ways. In one place it says Lumos has recognition across all seven MACs, and in another it gives "over 85% of the total US Medicare payment coverage" [R14]. The November 2025 announcement says the seven MACs represent "over 100% of the total US Medicare payment coverage" [R10]. All three are quoted as released.
Recognising the code lets a clinic submit a claim. The next step is a written coverage policy from each MAC, and Lumos said in November 2025 that it would work with each MAC on one [R10]. The annual report lists progressing those policies as an FY27 aim [R14].
How many FebriDx claims are being paid
In May 2026 Lumos said more than 90 per cent of the FebriDx claims submitted by clinics were being paid, and that the average payment among paying accounts was above the US$41.38 Medicare rate [R9]. The company said the data was "still in its infancy and not yet statistically significant" [R9]. It gave the same figure, as at 27 July 2026, in its announcement of 15 September 2026 [R15]. Lumos calls the US$41.38 a reimbursement benchmark for providers and insurers [R9]. It is the Medicare fee schedule amount, and each insurer sets its own rate.
Margins in the sales chain
FebriDx reaches a US clinic through a chain. Lumos makes it and sells it to PHASE Scientific, which holds the exclusive US distribution rights. PHASE sells through a contract sales force and through large medical distributors such as Henry Schein and McKesson. Two other firms support the sale. AcuityMD uses insurance claims data to find the clinics with the most patients, and PRO-spectus helps clinics set up their billing (FIG. 07) [R12].
Lumos has published the margins in that chain. The annual report gives Lumos a product gross margin of 60 per cent or more [R14]. It gives PHASE a distributor margin of 30 per cent or more and sub-distributors 20 to 30 per cent. The clinic bills US$41.38. Lumos receives some fraction of the US$41.38 for each test, after PHASE's margin and, where one is used, a sub-distributor's margin. The price Lumos charges PHASE is not public, so that fraction cannot be calculated.
EARLIER SAMSO COVERAGE Proteomics International went through the same US billing step for its PromarkerD blood test, covered in PromarkerD Gains US Billing Code in July 2025. Echo IQ took an FDA-cleared diagnostic into US health systems, covered in Echo IQ, a Fully Funded, FDA-Cleared Cardiac-AI Company in July 2026. How to read the trial evidence for a diagnostic blood test is also covered in Cancer Blood Tests in Australia and Where BCAL Diagnostics Fits, published in October 2026. |
7.00 — THE PHASE SCIENTIFIC AGREEMENT
Reading the US$317 million
On 16 July 2025 Lumos signed a six-year exclusive agreement with PHASE Scientific International to distribute FebriDx in the United States [R5]. PHASE is a diagnostics company based in Hong Kong with offices in Southern California. It sells rapid tests under its INDICAID brand and can sell a co-branded INDICAID FebriDx [R5]. Lumos keeps the intellectual property and remains the manufacturer.
What has been paid
The agreement set out four early payments, and all four have been received. FIG. 08 shows them in order. PHASE paid a US$1.0 million exclusivity fee and a US$1.0 million prepaid order on signing. It paid a further US$1.5 million prepaid order when Lumos lodged its waiver application in August 2025. It paid US$5.0 million when the waiver was granted, which Lumos received on 14 April 2026 [R5] [R8]. That is US$8.5 million in total [R13]. All four payments are non-refundable [R14].
Only the exclusivity fee was counted as revenue when it was paid [R14]. The prepayments are counted as revenue only when Lumos ships the product they pay for. The first US$2.5 million had all been shipped and counted by April 2026 [R26]. Of the US$5.0 million, US$4.85 million was still unshipped at 30 June 2026 and is held on the balance sheet as a liability to deliver product. The annual report expects it to be shipped, and counted as revenue, by June 2027 [R14]. On 4 August 2026 PHASE placed a US$767,800 order against it, for delivery by October 2026 [R17].
So most of the cash PHASE has paid is for product Lumos still has to ship.
What depends on future orders
The rest of the US$317 million, US$308.5 million, is described in the company's April 2026 presentation as "aggregated minimum order quantities" for years two to six, paid "on future delivery of product" [R26]. The minimum order quantities rise each year. The year-by-year figures have not been published [R14].
The original announcement set out three terms that affect the total. The US$317 million assumes PHASE meets all of its payment milestones and all of its minimum order quantities. If the waiver had not been granted, the minimums would have been set at 7 per cent of the waived figures, for a total of about US$25 million. The waiver was granted in March 2026, so the higher minimums apply. At three years after the waiver, Lumos may adjust the commercial terms if the minimums are not met, or change the terms after good-faith discussions [R5].
How Lumos has described the US$317 million
Lumos has described the US$317 million in several ways over the past 15 months. On 16 July 2025 it described the agreement as "valued at up to US$317 million" [R5]. The April 2026 results deck calls it a "minimal contract value" [R26]. The FY26 results announcement of 26 August 2026 calls it a contract "with a value of US$317 million" that includes "escalating minimum order commitments" [R13]. The annual report lodged the same day says Lumos "expects the total value of the agreement to reach a minimum of US$317.0 million", if the payment milestones and minimum orders are met. Elsewhere it calls it the "minimum contracted value" [R14]. All of these are quoted as released.
Read together, the documents describe the same structure. US$8.5 million has been paid. The other US$308.5 million arrives only if PHASE orders and takes delivery of its minimum quantities in each of years two to six. Orders above the minimums would add to the total. PHASE's August order counts towards a separate year 1 minimum [R17]. The US$317 million is the value of the contract if both sides perform.
8.00 — THE US ROLLOUT SO FAR
From one urgent care clinic to 215 sites
Lumos is targeting urgent care first. Respiratory illness is the most common reason people visit an urgent care centre [R12]. The company focuses on the 100 largest urgent care groups in the country. It says these own about 40 per cent of all US urgent care sites, a little over 5,700 clinics [R11] [R12].
WellStreet, the first group
The first customer was WellStreet Urgent Care, a chain based in Atlanta, Georgia. It started a pilot at one Atlanta clinic in October 2025 [R27]. In April 2026, after the waiver, WellStreet agreed to expand to 43 more clinics in Georgia and Michigan, which Lumos says was completed by mid-June 2026 [R11] [R27]. Lumos expects the rollout to reach all of WellStreet's network over the following three to nine months [R14]. The size of that network has been given as about 140, 163 and 165 clinics in different documents [R14] [R27].
The site count
FIG. 09 plots the count of live sites as Lumos has reported it. A live site is a clinic that has ordered FebriDx and is using it. The company reported more than 100 sites in 18 states on 11 June 2026, more than 170 in 24 states on 27 July, and 215 in 26 states on 15 September 2026 [R25] [R11] [R15]. A further 405 sites were trying the test in what Lumos calls clinical and economic validation, up from 350 in July [R12] [R15].
The annual report's timeline dates the 170 sites and 24 states to 11 June 2026 [R14]. The presentation released on 11 June gives "100+" sites in 18 states for the same date [R25]. Both are quoted as released.
In July Lumos reported that the first top-100 group beyond WellStreet was rolling FebriDx out to more than 30 sites. The group is owned by a large health system [R16]. On 15 September Lumos said two more top-100 urgent care groups had agreed to roll FebriDx out across more than 40 sites. Both are owned by large US health systems. Two other groups were testing it across more than 45 sites [R15]. Doug Ward, the chief executive, described the new groups in the 15 September announcement [R15].
These are sophisticated organisations that evaluate diagnostics on clinical utility, workflow fit and economics before committing sites, and they are now moving into rollout ahead of the respiratory season.
The groups are not named, and Lumos has not said how many tests the new sites have ordered.
How many patients a live site sees
Lumos estimates that the 215 live sites see 0.9 million to 1.2 million respiratory visits a year [R15]. The figure is built from industry averages, about 34 patients a day per urgent care site with 35 to 40 per cent of visits respiratory [R15]. It counts patients through the door. The number tested will be smaller, because the test is cleared only for ages 12 to 64 and only within three days of a fever starting, and not every respiratory patient will be tested [R3].
Lumos timed the rollout around the US flu season. US respiratory testing is lowest in the northern summer. The flu season usually builds from November and peaks between December and February [R12]. Lumos planned to use the US spring and summer to sign clinics so they would be ready for that season [R9]. The number of tests each live site uses has not been published. The quarterly reports will give the first read on it, through orders from PHASE. Those orders can run ahead of or behind use in clinics, because Lumos counts revenue when it ships to PHASE [R15].
9.00 — THE NUMBERS
Revenue, cash and the going concern note
Revenue
FY26 revenue was US$13.2 million, up 6 per cent [R13]. It came from two businesses. FIG. 10 is the company's chart of the last five quarters.
Products brought in US$4.28 million, of which FebriDx was US$3.92 million, up from US$0.42 million a year earlier [R14]. Most of those FebriDx sales were orders from PHASE, with the large orders shipped in February and March 2026 [R11]. On 1 April 2026 Lumos announced a US$1.3 million order from PHASE, its largest to date [R31]. Product revenue in the June quarter was US$0.16 million [R11]. Lumos put that down to the timing of the large March-quarter orders and the quiet US summer [R11].
At least US$2.5 million of the US$3.92 million was product shipped against PHASE's first prepayments [R26]. The annual report holds US$4.85 million of the US$5.0 million as a liability at 30 June 2026 [R14]. The 4 August announcement calls PHASE's August order the initial order against the US$5.0 million [R17]. Both are quoted as released. The cash for those shipments had arrived earlier. The same applies to the US$4.85 million still to be shipped. They will be counted as revenue, but the cash for them came in April 2026 [R14] [R17].
The results announcement says FebriDx revenue rose 875 per cent [R13]. The annual report says it rose 833 per cent, from US$0.42 million to US$3.92 million [R14]. Both are quoted as released.
Services brought in US$8.91 million [R14]. The fall from US$10.6 million the year before came mostly from the Hologic contract. Hologic paid an upfront licence fee of US$10.0 million in 2024, which Lumos counts as revenue spread over the life of the project. When the project was extended to about June 2028, the amount counted each year fell, from US$4.6 million in FY25 to US$1.4 million in FY26 [R11] [R14]. Other project revenue grew 24 per cent [R11].
Four customers made up 84.9 per cent of FY26 revenue, at 32.4, 27.7, 13.7 and 11.1 per cent. The annual report does not name them [R14].
Cash
Lumos ended June 2026 with US$15.4 million in cash [R11]. Operating cash flow for the June quarter was an inflow of US$2.7 million, which included the US$5.0 million from PHASE and US$1.7 million in government grants and tax incentives [R11]. By Samso's arithmetic, the other customer receipts in the quarter were about US$2.0 million, which is US$7.0 million of customer receipts less the US$5.0 million prepayment. Operating payments in the quarter were US$5.8 million [R11]. Once the PHASE prepayment and the grants are set aside, the business paid out more cash in the quarter than its customers paid in.
Lumos is also spending on its Carlsbad site. It paid US$2.1 million to its building contractor in the June quarter and expects about US$0.5 million more in the first half of FY27 [R11].
The going concern note
The directors and the auditor both drew attention to the company's ability to keep funding itself. Note 2 of the FY26 accounts says the circumstances "indicate a material uncertainty which may cast significant doubt" on whether the group will continue as a going concern [R14]. The auditor, William Buck, signed an unmodified opinion and added a paragraph drawing attention to that note [R14].
Note 2 says net current assets were US$12.59 million if the non-refundable prepayments held as liabilities are left out [R14]. The annual report lists the need to raise more money, which may not be available on good terms, among its risks [R14].
The AGM on 13 November 2026 will ask shareholders to renew the additional 10 per cent placement capacity under Listing Rule 7.1A. The notice says Lumos is not proposing an issue under it at present [R24].
The share price
FIG. 11 shows the share price since January 2025. The shares rose from under 3 cents before the PHASE agreement to above 30 cents in early 2026 [R30]. They fell after the March placement at 22.5 cents and have mostly traded between 8 and 13 cents since June 2026 [R30]. They closed at 8.8 cents on 21 October 2026, 61 per cent below the placement price.
10.00 — WHAT COMES NEXT
Children, a new factory and the first winter
The paediatric study
Children are the next group Lumos wants FebriDx cleared for. Lumos says about 60,000 US clinicians treat children aged 2 to 12 [R18]. The test is cleared today for ages 12 to 64. Lumos says success would expand the patient population the test is cleared for by about 20 per cent [R13]. Its July quarterly report gives the expansion of the US market as 15 to 20 per cent [R11].
The study started on 22 October 2025 and aims to enrol 500 to 800 children aged 2 to 12 at about 20 US sites. It passed 250 patients in May 2026 [R18]. It is funded by the Biomedical Advanced Research and Development Authority (BARDA), a US government agency. BARDA has committed US$6.2 million across 12 milestones, and Lumos had received US$2.6 million of that by June 2026 [R14].
The study was expected to take about 12 months [R18]. The annual report says Lumos is still working with BARDA and the FDA on the best study design and regulatory path. It says Lumos will update the market on progress and on any changes closer to the end of 2026 [R14]. The study has reached the end of its expected 12 months and its design may still change, so that update is where the next step will be set out.
The Carlsbad factory
PLATE 03 is the building Lumos is moving into. The July 2026 presentation says it is consolidating into a single facility of about 37,000 square feet, with a temperature-controlled warehouse 20 times larger than its current one and twice the manufacturing laboratory space. It expects to finish in November 2026 [R12]. The annual report describes the aim as a path to 10 million tests a year, ahead of the 2027 to 2028 respiratory season [R14]. Current capacity in tests a year has not been published.
The Carlsbad facility is also one of the chief executive's pay targets. One tranche of the performance rights proposed for Doug Ward at the 2026 AGM vests if three consecutive commercial batches are released from the new facility before 30 June 2027. Other tranches vest at FebriDx revenue of more than US$7.5 million, US$10 million and US$15 million, and total revenue of more than US$20 million [R24].
The market size
Lumos describes the waived US opportunity as more than US$1.0 billion a year, from about 80 million respiratory infection patients a year and more than 300,000 waived sites [R6] [R13]. The patient figure is drawn from a 2024 report by Precision Business Insights, a market research firm, and the site figure from the CMS CLIA database of March 2024 [R6]. These are the company's estimates of the whole market. The documents do not say whether the 80 million is limited to the ages and symptoms on the label.
Dates to watch
Lumos will report its September quarter on 27 October 2026 [R28]. It covers July to September 2026, the months in which Lumos was signing clinics ahead of the flu season [R15]. The AGM is on 13 November 2026 [R24]. The Carlsbad move is due in November, and the paediatric study update is due by the end of 2026 [R12] [R14]. The flu season itself runs from about November to March.
11.00 — THE OTHER SIDE OF THE CASE
What could slow FebriDx down
THE OTHER SIDE FebriDx is less reliable when it reads bacterial. In the main trial a little over four in ten bacterial results were for patients the reference panel did not class as bacterial, so a clinic that treats every bacterial result with antibiotics will still prescribe some that are not needed [R2]. The benefit depends on how doctors use the result, and a US figure for the fall in prescribing has not yet been published. The trial was also funded by Lumos, and its reference method partly measured the same immune response as the test [R2]. Lumos has one US distributor. All US sales go through PHASE, so orders can run ahead of or behind clinic use, as 8.00 sets out [R15]. The US$308.5 million beyond the money already paid depends on PHASE meeting the rising minimum orders in 7.00 [R26]. Insurer payment is at an early stage. The 90 per cent claims-paid figure in 6.00 comes from early data [R9]. Insurers can change or refuse coverage, and the annual report lists that among its risks [R14]. Competing tests could appear. The annual report warns that rivals with more resources could cut prices, and that competitors could bring out tests that work better [R14]. Lumos withdrew its earlier combined flu and COVID-19 test, ViraDx, after new competing tests came to market at low prices [R14]. Lumos may need more funding, as the going concern note in 9.00 sets out [R14]. A further capital raising near the current market price would dilute existing holders. About 91 million unlisted options and 30 million performance rights were also on issue on 20 October 2026 [R23]. |
Several parts of the case are already in place. The FDA has cleared the test twice, the second time for use by ordinary clinic staff [R1] [R3]. It has a dedicated billing code at a published Medicare rate [R4]. PHASE has paid US$8.5 million in non-refundable money [R13] [R14]. Lumos reported 215 clinics using FebriDx in September 2026, before the flu season began [R15].
Lumos says its patents on the MxA and CRP combination run in the United States to 2038 [R12].
SAMSO TAKE FebriDx is designed to help with a common question in a winter clinic, which is whether a patient needs an antibiotic. The trial evidence is strongest in ruling a bacterial infection out, which is where that question is hardest to answer without a test. The evidence does not yet show how many tests a US clinic will use over a full year. The first full flu season with the waiver will start to answer that. What Lumos earns on each test after PHASE and the sub-distributors take their margins will stay unknown until Lumos publishes what it charges PHASE. The PHASE contract adds up to US$317 million if PHASE buys every minimum order over six years. PHASE has paid US$8.5 million so far, and the other US$308.5 million depends on orders in years two to six. How much of it does an investor expect PHASE to order, once the 2026 to 2027 flu season shows how clinics use the test? |
THE VOCABULARY, IN PLAIN ENGLISH Acute respiratory infection (ARI) A recent infection of the nose, throat, airways or lungs, such as a cold, flu, strep throat or pneumonia. Antimicrobial resistance The process by which bacteria stop responding to antibiotics, made faster by using antibiotics when they are not needed. MxA (myxovirus resistance protein A) A protein white blood cells make when the body detects a virus. High MxA points to a viral infection. CRP (C-reactive protein) A protein the liver makes when the body is inflamed. It rises with bacterial infections and with some viral ones. Lateral flow immunoassay A test in which a liquid sample soaks along a strip and printed antibodies show a coloured line when a protein is present. Home COVID tests work this way. Sensitivity Of the patients who really have the condition, the share the test catches. Specificity Of the patients who do not have the condition, the share the test correctly leaves alone. Negative predictive value (NPV) When the test says the condition is absent, how often that is right. Positive predictive value (PPV) When the test says the condition is present, how often that is right. Percent agreement How often two operators reading the same patient's test reach the same result. It measures consistency between people, not whether the result is correct. 510(k) An FDA path to market for a medium-risk device, granted when it is shown to be as safe and effective as one already sold. CLIA waiver A US classification for tests simple enough to be run by ordinary clinic staff in any clinic holding a Certificate of Waiver, without the certification needed for more complex tests. PLA code A Proprietary Laboratory Analyses billing code, issued for one company's branded test so insurers can pay for it. MAC A Medicare Administrative Contractor, one of seven regional firms that process Medicare claims for the US government. Urgent care A walk-in clinic for problems that need attention the same day but are not emergencies. Minimum order quantity (MOQ) The least a distributor has agreed to buy in a given year under its contract. Going concern note A statement in the accounts that there is significant doubt about whether the company can keep operating and paying its debts. The directors still expect it to, and say why. BARDA The Biomedical Advanced Research and Development Authority, a US government agency that funds medical products for public health. |
12.00 — REFERENCES AND SOURCES
Where every number comes from
Each source below carries an identifier, [R1] to [R32], and the same identifier appears in the text where the source is used. FIG. 02, 06, 07 and 10 and PLATE 01, 02 and 03 are reproduced from Lumos Diagnostics documents and its website, credited in each caption. FIG. 01, 03, 04, 05, 08, 09 and 11 are original Samso illustrations of sourced data. Company figures are dated by the document they come from. Share prices are as at the close stated at the front of the piece.
[R1] US Food and Drug Administration, "510(k) Substantial Equivalence Determination Decision Summary, K230917, FebriDx Bacterial / Non-bacterial Point-of-Care Assay", decision 30 June 2023 from the FDA 510(k) database entry, 16 pages, Table 12 and Table 13 on pages 13 and 14. www.accessdata.fda.gov/cdrh_docs/reviews/K230917.pdf
[R2] Shapiro NI, Filbin MR, Hou PC and others, "Diagnostic Accuracy of a Bacterial and Viral Biomarker Point-of-Care Test in the Outpatient Setting", JAMA Network Open 5(10), e2234588, published 18 October 2022. doi 10.1001/jamanetworkopen.2022.34588. Table 2, Table 3, Limitations and funding statement. jamanetwork.com/journals/jamanetworkopen/fullarticle/2797588
[R3] US Food and Drug Administration, "510(k) Substantial Equivalence Determination Decision Summary, K260787, FebriDx Bacterial / Non-Bacterial Assay", 9 pages, Indications on page 2, user study and Table 5 on pages 6 to 8. Decision date 24 March 2026 from the FDA 510(k) database entry. www.accessdata.fda.gov/cdrh_docs/reviews/K260787.pdf
[R4] Centers for Medicare and Medicaid Services, Clinical Laboratory Fee Schedule, CY2026 Q4 public use file (26CLABQ4), rows for code 0442U. www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/files/26clabq4
[R5] Lumos Diagnostics, "Lumos Diagnostics Signs Pivotal, Exclusive U.S. Distribution Agreement with PHASE Scientific for FebriDx", ASX announcement, 16 July 2025, pages 1 to 3. announcements.asx.com.au/asxpdf/20250716/pdf/06lv8rhbxv6c4p.pdf
[R6] Lumos Diagnostics, "US FDA Grants CLIA Waiver for FebriDx", ASX announcement, 27 March 2026. lumosdiagnostics.com/announcements?announcement=626
[R7] Lumos Diagnostics, "Lumos Completes Placement of A$20.0 million and Announces Share Purchase Plan", ASX announcement, 27 March 2026. lumosdiagnostics.com/announcements?announcement=628
[R8] Lumos Diagnostics, "Lumos receives US$5.0 million Milestone Payment from Phase Scientific for FebriDx", ASX announcement, 14 April 2026. lumosdiagnostics.com/announcements?announcement=643
[R9] Lumos Diagnostics, "FebriDx U.S. Rollout and Reimbursement Update - Amended", ASX announcement, 18 May 2026. lumosdiagnostics.com/announcements?announcement=660
[R10] Lumos Diagnostics, "Lumos Secures 100% U.S. Medicare Reimbursement Recognition for FebriDx", ASX announcement, 21 November 2025, including the map of MAC jurisdictions on page 2. lumosdiagnostics.com/announcements?announcement=607
[R11] Lumos Diagnostics, "Quarterly Activities/Appendix 4C Cash Flow Report", ASX announcement, 27 July 2026, pages 1 to 6 and Appendix 4C. lumosdiagnostics.com/announcements?announcement=576
[R12] Lumos Diagnostics, "Investor Presentation", ASX announcement, 27 July 2026, slides 4, 6, 10, 15, 19, 20, 21, 24, 25, 27, 28, 30 and 31. lumosdiagnostics.com/announcements?announcement=577
[R13] Lumos Diagnostics, "FY26 Achievements Positions Lumos for Future Growth" (FY26 Full Year Results Announcement), ASX announcement, 26 August 2026. lumosdiagnostics.com/announcements?announcement=671
[R14] Lumos Diagnostics, "FY26 Annual Report", ASX announcement, 26 August 2026, 100 pages. Operating and financial review, risk factors, Note 2 going concern, Note 18 contract liabilities, independent auditor's report by William Buck Audit (Vic) Pty Ltd, and shareholder information. lumosdiagnostics.com/announcements?announcement=670
[R15] Lumos Diagnostics, "FebriDx Commercial Traction Continues to Advance Across Priority U.S. Accounts", ASX announcement, 15 September 2026. lumosdiagnostics.com/announcements?announcement=676
[R16] Lumos Diagnostics, "FebriDx Commercial Traction Advancing Across Priority U.S. Accounts", ASX announcement, 21 July 2026. lumosdiagnostics.com/announcements?announcement=575
[R17] Lumos Diagnostics, "Lumos receives US$767,800 FebriDx order from PHASE Scientific", ASX announcement, 4 August 2026. lumosdiagnostics.com/announcements?announcement=582
[R18] Lumos Diagnostics, "Lumos Commences FebriDx CLIA Waiver Pediatric Study", 22 October 2025, and "FebriDx Paediatric Study 250 Patient Enrolment Milestone Achieved", 14 May 2026, ASX announcements. lumosdiagnostics.com/announcements?announcement=658
[R19] Lumos Diagnostics, "FebriDx Real-World Data Shows Reduced Antibiotic Use and System Cost Savings", ASX announcement, 24 September 2025, attaching the poster by Fazlee M, Menzies W, Chadwick S and Linden DJ, Primary Care Respiratory Society conference. lumosdiagnostics.com/announcements?announcement=593
[R20] US Centers for Disease Control and Prevention, "Outpatient Antibiotic Use Materials", page updated 17 September 2026, "At a glance". www.cdc.gov/antibiotic-use/communication-resources/improve-outpatient-use.html
[R21] Lumos Diagnostics, "Lumos Diagnostics Board Changes", ASX announcement, 12 October 2026. lumosdiagnostics.com/announcements?announcement=683
[R22] Ryder Capital Limited, "Change in substantial holding from RYD" (Form 604), lodged by Lumos Diagnostics with the ASX, 15 September 2026. lumosdiagnostics.com/announcements?announcement=679
[R23] Lumos Diagnostics, "Application for quotation of securities - LDX" (Appendix 2A), ASX announcement, 20 October 2026, Part 4. lumosdiagnostics.com/announcements?announcement=688
[R24] Lumos Diagnostics, "Notice of Annual General Meeting and Proxy Form", ASX announcement, 12 October 2026, Resolutions 6 and 10. lumosdiagnostics.com/announcements?announcement=684
[R25] Lumos Diagnostics, "Investor Webinar", FebriDx US commercial update, ASX announcement, 11 June 2026. lumosdiagnostics.com/announcements?announcement=665
[R26] Lumos Diagnostics, "Investor Presentation", Q3 FY26 results, ASX announcement, 21 April 2026, slide 17. lumosdiagnostics.com/announcements?announcement=649
[R27] Lumos Diagnostics, "Lumos Diagnostics Enters Agreement with WellStreet Urgent Care to Advance FebriDx Testing", 16 October 2025, and "Lumos Diagnostics Expands Agreement with WellStreet Urgent Care to 43 Locations", 14 April 2026, ASX announcements. lumosdiagnostics.com/announcements?announcement=645
[R28] Lumos Diagnostics, "Q1 FY27 Results Release Date and Webinar Invitation", ASX announcement, 19 October 2026. lumosdiagnostics.com/announcements?announcement=687
[R29] Lumos Diagnostics, company website, product and home page photographs, accessed 22 October 2026. www.lumosdiagnostics.com
[R30] Yahoo Finance, daily closing prices for LDX.AX, January 2025 to 21 October 2026, read 22 October 2026. finance.yahoo.com/quote/LDX.AX/history
[R31] Lumos Diagnostics, "Lumos receives largest FebriDx order to-date", ASX announcement, 1 April 2026. lumosdiagnostics.com/announcements?announcement=631
[R32] Natural Earth, Admin 0 countries and Admin 1 states, 1 to 50 million scale, public domain. www.naturalearthdata.com
Cover photo, a clinician with a FebriDx test, Lumos Diagnostics website home page, accessed 22 October 2026 (www.lumosdiagnostics.com).
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