Lumos Diagnostics Holdings Ltd CEO Doug Ward talked with Proactive about the company securing a major regulatory milestone in the United States, with the Food and Drug Administration granting a CLIA waiver for its FebriDx point-of-care test.
Ward explained that the waiver is a transformative step for Lumos Diagnostics Holdings Ltd, unlocking access to a significantly larger market across primary care and urgent care settings. He noted that the opportunity spans approximately 80 million patient visits annually in the US, where clinicians must quickly determine whether infections are bacterial or viral.
In addition, Lumos Diagnostics Holdings Ltd has announced a $20 million capital raise to fund sales, marketing, and manufacturing scale-up as it prepares for commercial rollout.
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