Another interesting and IMO underrated aspect of the CLIA waiver clinical trial is the amount of support that LDX is receiving from BARDA (a division of the US Govt Department of Health).
BARDA is not only funding the study with an initial grant of approximately US $3 million (with a further approx US $5 Million available in the future), but is also providing study support, clinical support, regulatory expertise support, and support in the FDA application to achieve the CLIA waiver.
IMO, such strong support from BARDA ( a US govt entity) almost amounts to BARDA submitting the FDA application themselves (after all, BARDA is funding the study, providing clinical and technical support for the study, and also providing support in the FDA application).
Considering such strong support from BARDA (a US Govt entity), IMO, it is highly likely that LDX will be successful in their FDA application for a CLIA waiver (although nothing is guaranteed).
In which case, the below quote from the recent announcement becomes very interesting:
"At the conclusion of the study, Lumos hopes to achieve a successful reclassification of FebriDx from moderate complexity to a CLIA-waived device. This would significantly increase its market reach in the US, with the total addressable market expanding from 18,000 to around 270,000 potential customer sites — a 15-fold increase — unlocking a potential market opportunity, valued at approximately US$1.7 billion annually."
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