The US Food and Drug Administration (FDA) is the govt department responsible for granting the LDX CLIA waiver (as per below image).
A successful CLIA waiver will reportedly open up the number of potential sites which can buy FebriDx from 18,000 sites pre-waiver, to 270,000 sites post-waiver. In monetary terms the total available market (TAM) will increase from US $118 million dollars per annum, pre CLIA waiver, to US $1.7 billion per annum, post CLIA waiver (see image below).
So lets see what the FDA has to say about the global problem of antimicrobial resistance. The FDA happens to have a whole webpage addressing this important global problem: https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance
Some key points from the FDA
The FDA's role and strategic approach to combating antimicrobial resistance is shown below (it seems like the FDA's policy on AMR is completely aligned with LDX's aims with FebriDx):
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