Response to ASX Aware Letter
| Stock | Atomo Diagnostics Ltd (AT1.ASX) |
|---|---|
| Release Time | 17 Apr 2026, 10:23 a.m. |
| Price Sensitive | Yes |
Atomo Diagnostics responds to ASX Aware Letter
- Atomo was not in possession of disclosable information until Lumos announced CLIA waiver approval
- Atomo's trading halt was a precautionary measure, not an acknowledgment of disclosable information
- Atomo complied with Listing Rule 3.1 and did not disclose any confidential information to brokers
Atomo Diagnostics Limited (AT1) refers to an ASX Aware Letter dated 9 April 2026 and provides the following responses. Atomo is the exclusive licensor, manufacturer and supplier of Pascal cassettes to Lumos Diagnostics Holdings Ltd (LDX) for its FebriDx rapid, point-of-care testing product. Lumos previously announced a ~US$300m supply contract for FebriDx contingent on CLIA waiver approval. Atomo has kept the market informed on the status of Lumos' CLIA waiver application. On 25 March 2026, Lumos requested and was granted a trading halt, pending an announcement regarding the FDA's response to its FebriDx CLIA waiver application. On 27 March 2026, prior to market open, Lumos released an announcement confirming that the FebriDx test had received CLIA waiver approval from the FDA. Atomo's position is that it was not in possession of disclosable information until the Lumos announcement, and its trading halt was a precautionary measure, not an acknowledgment of disclosable information. Atomo complied with Listing Rule 3.1 and did not disclose any confidential information to brokers prior to the public announcement. Atomo subsequently released its own announcement reiterating the CLIA waiver outcome and announcing a capital raising.