Atomo Diagnostics Limited Gains Upside from FebriDx® FDA Approval
Atomo Diagnostics Limited (ASX: AT1) highlighted a significant growth opportunity following the US FDA’s CLIA waiver approval for Lumos Diagnostics’ FebriDx® test, which utilises Atomo’s proprietary Pascal cassette. The approval is expected to expand the addressable US market by approximately 15 times, enhancing demand potential for the product. Under existing agreements, Atomo is the exclusive manufacturer and supplier of Pascal cassettes for FebriDx®, with supply arrangements extending to June 2031.
The partnership includes committed minimum order volumes and potential revenues linked to large-scale distribution agreements, including a deal supporting up to US$313 million in test sales over six years. Atomo has already recorded orders of around AU$1.57 million since mid-2025, with further growth anticipated as production scales. Management noted that Pascal’s proven performance supports broader commercial opportunities and positions the company to benefit from increasing global demand for rapid diagnostic solutions.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au
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Atomo Diagnostics Limited Gains Upside from FebriDx® FDA Approval
Atomo Diagnostics Limited (ASX: AT1) highlighted a significant growth opportunity following the US FDA’s CLIA waiver approval for Lumos Diagnostics’ FebriDx® test, which utilises Atomo’s proprietary Pascal cassette. The approval is expected to expand the addressable US market by approximately 15 times, enhancing demand potential for the product. Under existing agreements, Atomo is the exclusive manufacturer and supplier of Pascal cassettes for FebriDx®, with supply arrangements extending to June 2031.
The partnership includes committed minimum order volumes and potential revenues linked to large-scale distribution agreements, including a deal supporting up to US$313 million in test sales over six years. Atomo has already recorded orders of around AU$1.57 million since mid-2025, with further growth anticipated as production scales. Management noted that Pascal’s proven performance supports broader commercial opportunities and positions the company to benefit from increasing global demand for rapid diagnostic solutions.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au