• FebriDx test received CLIA waiver approval from US FDA
• Pascal cassette played a pivotal role in FebriDx performance
• CLIA waiver approval estimated to expand US addressable market by 15x

Atomo Diagnostics Limited (ASX:AT1) has announced that Lumos Diagnostics's (ASX:LDX) FebriDx test has received CLIA waiver approval from the US Food and Drug Administration (FDA). The FebriDx test has been exclusively commercialized in Atomo's patented Pascal cassette, with the performance of Pascal playing a pivotal role in the CLIA waiver approval. CLIA waiver approval is estimated by Lumos to expand the US addressable market by around 15 times. In an agreement signed in July 2025 between Lumos and PHASE Scientific for supply of FebriDx in the US, there are contracted Minimum Order Quantities (MOQs) of up to US$313 million in FebriDx revenues over the six-year term, subject to CLIA waiver which has now been secured. Atomo is the exclusive licensor, manufacturer and supplier of Pascal cassettes to Lumos for FebriDx, and each FebriDx test sold to Phase requires Lumos to order an assembled Pascal cassette from Atomo under an agreement that runs until June 2031. Atomo has received orders from Lumos for Pascal of approximately A$1.57 million since the signing of the agreement with Phase in July 2025. Excluding IP licensing payments already made by Lumos, the agreement has committed Pascal revenues totaling US$3.4m (A$5.2m), based on FebriDx securing CLIA waived status from the US FDA. Atomo is now actively scaling up Pascal operations to support growing demand from Lumos and other new pipeline customers.

Atomo is now actively scaling up Pascal operations to support growing demand from Lumos and other new pipeline customers, who have seen the outstanding performance that Pascal delivered for FebriDx and its proven ability to support valuable CLIA waiver approvals in the US market.