Atomo Diagnostics Flags Pascal Test Cassette's Performance in Lumos' Test of Diagnostic Product

MT Newswires Live

2025/08/21

Atomo Diagnostics (ASX:AT1) said that its Pascal test cassette performed "exceptionally well" in US clinical studies supporting a Clinical Laboratory Improvement Amendments (CLIA) waiver submission for a test of Lumos Diagnostics Holdings' (ASX:LDX) product, FebriDx, according to a Thursday Australian bourse filing.

FebriDx secured a 510k clearance from the US Food and Drug Administration using the Pascal cassette and recently completed a CLIA waiver trial and submission to the FDA using the Pascal cassette.

The FebriDx test uses Atomo's Pascal test cassette to deliver improved usability and reliability in point-of-care settings, and Atomo is the exclusive licensor, manufacturer, and supplier of the cassettes to Lumos.

Atomo and Lumos are now in talks regarding the supply of Pascal cassettes for the PHASE agreement.

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