Atomo defends timing of CLIA waiver disclosure after ASX query

An announcement from Atomo Diagnostics Ltd. ( (AU:AT1) ) is now available.

Atomo Diagnostics has responded to a query from ASX Compliance over the timing and handling of its market disclosure on the U.S. CLIA waiver approval for Lumos Diagnostics’ FebriDx test, which is expected to drive increased demand for Atomo’s Pascal cassettes. The company argues it did not hold disclosable, market-sensitive information until Lumos publicly announced the waiver approval on 27 March 2026 and says its own subsequent trading halt and announcement on 30 March were precautionary and consistent with its continuous disclosure obligations, aiming to avoid a false market in its shares.

The response letter draws a distinction between high-level preliminary correspondence received on 25 March, which Atomo says lacked detail and was not price-sensitive, and the formal waiver approval that was later disclosed by Lumos. This stance is central to Atomo’s defence of its compliance with ASX Listing Rule 3.1, and highlights the regulatory scrutiny around disclosure practices for companies whose revenues are leveraged to major counterparties’ regulatory and commercial milestones.

More about Atomo Diagnostics Ltd.

Atomo Diagnostics Ltd is a medical diagnostics company that designs, manufactures and supplies rapid point-of-care testing devices. The company is the exclusive licensor, manufacturer and supplier of Pascal cassettes used by Lumos Diagnostics for its FebriDx test, targeting growing demand in the U.S. point-of-care market following regulatory milestones.

Average Trading Volume: 2,349,202

Technical Sentiment Signal: Hold

Current Market Cap: A$25.23M

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