Lumos Diagnostics Holdings Limited

ASX:LDX

Lumos Diagnostics Holdings Limited

ASX:LDX
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$0.290 (+7.4%)
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#70
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2
Held by
4
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XXXXXX
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XXXXXX
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Valuation of $0.270
Stevie_B
Added 2 months ago

Here is a regulatory-driven weighted valuation for Lumos Diagnostics (LDX)

Regulatory-Driven Weighted Valuation — LDX

1. Scenario Valuations (Per Share)

These are the intrinsic values under each outcome:

  • Bear Case (Regulatory failure or multi-year delay): A$0.10
  • Base Case (CLIA waiver granted; standard adoption curve): A$0.22
  • Bull Case (CLIA waiver granted + favourable reimbursement + faster uptake): A$0.42


2. Regulatory-Driven Probabilities

Weights are assigned based primarily on regulatory risk, not commercial execution.

Given LDX’s current position (late-stage CLIA submission, strong data, clear FDA pathway), a rational regulatory weighting is:

  • Bear Probability: 10%
  • (Regulatory failure or material delay)
  • Base Probability: 60%
  • (Approval with typical adoption)
  • Bull Probability: 30%
  • (Approval + reimbursement momentum + strong early adoption)


These numbers reflect that the major binary risk = CLIA approval, and that probability is now well above 50%, but not certain.


3. Weighted Valuation Calculation

Bear: 0.10 × 0.10 = 0.010

Base: 0.22 × 0.60 = 0.132

Bull: 0.42 × 0.30 = 0.126


Regulatory-Weighted Valuation for LDX

= A$0.27 per share


4. Interpretation

  • A $0.27/sh regulatory-weighted valuation reflects a world where regulatory approval is the dominant driver, not commercial scale.
  • The valuation sits between the base and bull cases, consistent with high regulatory confidence.
  • It is above the simple weighted valuation (~$0.24) because regulatory success now carries 90% of the weighted probability.


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#Short Term Trading Opportunity
Stevie_B
Last edited 4 months ago
View author's company report

$LDX is largely a single product company with FebriDx.

FebriDx is a rapid point-of-care test that uses a fingerstick blood sample to aid in the differentiation between bacterial infection and non-bacterial etiology. FebriDx is intended to be used in urgent and emergency care settings.

Knowing whether a patient has a bacterial infection has a direct impact on reducing unnecessary antibiotic prescriptions, limiting the spread of antibiotic-resistant bacteria, and helping providers know when to, and when not to, initiate treatment.

FebriDX has previously been assigned a reimbursement code and Medicare reimbursement of USD $41 per test.

The company submitted a CLIA waiver application to the FDA for FebriDx in August. The data used to support this application seems quite robust.

https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02979439-2A1614136&v=undefined

Securing a CLIA waiver is necessary to allow the use of FebriDx in lower-complexity settings like physician offices and urgent care clinics, which currently lack the certification for high-complexity lab testing. 

MST Access published a report on $LDX in August 2025 following the submission of the application for the CLIA waiver. At the time the SP was 10c and MST Access had a valuation of 22c.

https://lumosdiagnostics.com/documents/2025/08/LDX.AX%20-%20FebriDx%20CLIA%20waiver%20submission%20(081925).pdf

$LDX has advised that the FDA will provide a decision on the CLIA waiver application sometime between Nov 2025 and Feb 2026

https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-03012887-2A1631243&v=undefined

$LDX anticipate that the CLIA waiver will be granted and have appointed Phase Scientific to distribute FebriDx on an exclusive basis in the US.

$LDX is of the view that a CLIA waiver will increase the TAM for FebriDx to in excess of 1B USD. Not yet sure how this figure was derived and will need to do further research.

The $LDX SP has risen 150+ percent since the company announced the submission of the CLIA waiver application 10 weeks ago. The current SP is 26c as of 24th October 2025.

IMO I think there is still a significant short term trading opportunity here with the SP likely to continue rising ahead of the CLIA waiver potentially being granted in the coming weeks/months.

I am seeking the help of other Straw-peeps to pour lots of cold water on this thesis. Also I’m particularly hoping @mikebrisy and @Chagsy can provide some input given their clin med / med tech expertise and knowledge.

Disc - Held in SM and I opened a small 10K position IRL last week.


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