Lumos Diagnostics Achieves Key Milestone with US FDA CLIA Waiver for FebriDx®
Lumos Diagnostics Holdings Limited (ASX: LDX) has reached a monumental milestone with the US FDA granting its FebriDx® point-of-care test a Clinical Laboratory Improvement Amendments (CLIA) waiver. This breakthrough follows the test’s 510(k) clearance and unlocks an expansive market opportunity valued at over US$1 billion, significantly increasing its addressable market by 15 times.
The CLIA waiver extends the test's use to over 80 million patients annually in the US, allowing for deployment in more than 300,000 locations such as primary care offices, urgent care centers, and retail health clinics. This opens up significant potential for broader adoption, with the company poised to capture a larger share of the rapidly growing market for acute respiratory infections. The milestone also triggers US$5.5 million in milestone payments, further strengthening Lumos’ financial position as it prepares for a broader commercial rollout of FebriDx®.
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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Lumos Diagnostics Achieves Key Milestone with US FDA CLIA Waiver for FebriDx®
Lumos Diagnostics Holdings Limited (ASX: LDX) has reached a monumental milestone with the US FDA granting its FebriDx® point-of-care test a Clinical Laboratory Improvement Amendments (CLIA) waiver. This breakthrough follows the test’s 510(k) clearance and unlocks an expansive market opportunity valued at over US$1 billion, significantly increasing its addressable market by 15 times.
The CLIA waiver extends the test's use to over 80 million patients annually in the US, allowing for deployment in more than 300,000 locations such as primary care offices, urgent care centers, and retail health clinics. This opens up significant potential for broader adoption, with the company poised to capture a larger share of the rapidly growing market for acute respiratory infections. The milestone also triggers US$5.5 million in milestone payments, further strengthening Lumos’ financial position as it prepares for a broader commercial rollout of FebriDx®.
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