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Atomo Diagnostics Limited (ASX:AT1)

ALERT: Price-sensitive ASX Announcement for AT1
Current share price for AT1 : $0.017 -0.023 (-57.50%)+
Announcement
Release
30 Mar 2026 9:29AM
Price at Release
$0.040
Full Release
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Summary
Atomo Diagnostics Limited announced that the FebriDx® test, which uses their Pascal cassettes, has received FDA CLIA waiver approval, significantly expanding its market potential in the US. This approval could increase the US addressable market for FebriDx by 15 times. Atomo, the exclusive licensor and supplier of the patented Pascal cassettes, has received orders worth approximately A$1.57 million since the agreement with Lumos Diagnostics in July 2025. The agreement is expected to secure Pascal revenues totaling US$3.4 million, dependent on the FebriDx's CLIA waiver status. The supply deal with Lumos is valid until June 2031, ensuring steady demand for Pascal cassettes. Atomo is scaling up its operations to meet the increasing demand driven by the CLIA waiver approval.
Key Points
  • Atomo Diagnostics Limited announced FebriDx® test has received FDA CLIA waiver approval.
  • The approval is expected to expand the US market significantly for the FebriDx test.
  • Lumos Diagnostics and PHASE Scientific have an agreement with minimum order quantities for the US market.
  • Atomo is the exclusive licensor and supplier of the Pascal cassettes used in FebriDx tests.
  • Orders worth A$1.57 million have been received by Atomo since an agreement in July 2025.
  • The agreement with Lumos forecasts Pascal revenues of US$3.4 million based on CLIA waiver.
  • The supply agreement for Pascal cassettes with Lumos extends until June 2031.
  • Atomo plans to scale up Pascal operations to meet increasing demand.
  • Pascal's performance was pivotal in securing the CLIA waiver for FebriDx.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.