Introduction to Lumos Diagnostics' US milestone

Lumos Diagnostics (ASX:LDX), a leader in rapid point-of-care diagnostics, has achieved a pivotal milestone with the approval of a new CPT PLA procedure code for its FebriDx test in the United States. The Centers for Medicare and Medicaid Services (CMS) has set a reimbursement rate of $41.38 per test, effective January 1, 2025. This approval is expected to enhance accessibility and adoption of FebriDx, facilitating reimbursement from both government and private insurers.

Summary of Lumos Diagnostics' strategic advancement

Lumos Diagnostics has secured a significant milestone with the approval of a new CPT PLA procedure code for its FebriDx test in the US, with a reimbursement rate set by CMS at $41.38 per test. This development is expected to improve the accessibility and adoption of FebriDx, a test capable of distinguishing between bacterial and non-bacterial infections at the point of care, addressing antibiotic overprescription issues. The company plans to engage with US payers to establish comprehensive reimbursement policies and aims to achieve CLIA waiver labeling for further market reach. This aligns with Lumos Diagnostics' strategy to expand its portfolio of diagnostic solutions and address public health challenges, such as antibiotic resistance.

Executive insights on FebriDx's US approval

The approval of the PLA code is a crucial step in the U.S. commercialization of FebriDx and an advancement toward removing access barriers.