https://medicalcountermeasures.gov/newsroom/2024/lumos/BARDA and...

https://medicalcountermeasures.gov/newsroom/2024/lumos/

BARDA and Lumos Diagnostics are partnering to support the clinical study and Clinical Laboratory Improvement Amendments (CLIA)-waiver regulatory submission for the company’s FebriDx (TM) bacterial/non-bacterial point-of-care test. This test can aid clinicians with their decisions about antibiotic use and therefore has the potential to improve antibiotic stewardship. In addition, achieving a CLIA-waiver for this test would allow tests to become available in more health care settings, including doctors’ offices and outpatient clinics, allowing for more rapid testing.

Under this partnership, BARDA will support a clinical study comparing test usage among untrained users in a CLIA-waived setting to trained users. In addition, BARDA will provide regulatory expertise and support for the CLIA-waiver submission to the FDA.

Waived tests include test systems that are simple to use and have low risk for erroneous results. If successful, this partnership has the potential to impact patient care by expanding testing to CLIA-waived, point-of-care settings, including physician offices, urgent care clinics, or other outpatient clinics. FebriDx provides a result in about 10 minutes. Faster readings for a bacterial or non-bacterial result can aid providers to make more informed decisions about patient treatment—which may lead to reduction of inappropriate antibiotic use.

FebriDx is a visually read, all-in-one, single-use test that is designed to assess whether an acute respiratory infection is bacterial or non-bacterial in origin. This first of its kind integrated test includes a lateral flow test strip, a built-in retractable safety lancet, blood collection and transfer tube, and buffer delivery system, which greatly simplifies the test protocol. The test qualitatively detects elevated levels of two proteins created by the body’s immune response that help differentiate between bacterial (C-reactive protein [CRP]) and non-bacterial (Myxovirus resistance protein A [MxA]) infections in a fingerstick blood sample. This assay currently has 510(k) Clearance for moderate and high-complexity use.

This award aligns with the goals laid out in BARDA’s 2022-2026 Strategic Plan, including development of emerging technologies that move testing closer to the patient and facilitating testing in limited healthcare resource settings. In addition, this effort will aid in the development of a diagnostic to inform antibiotic use.