$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.