Lumos starts ‘pivotal clinical study’ in US for point-of-care respiratory test

Lumos has begun a crucial study in the US for its FebriDx point-of-care test to aid in differentiation between bacterial and non-bacterial acute respiratory infections.

Lumos has started its FebriDx CLIA waiver study in the US. Pic via Getty Images.

• Lumos begins pivotal FebriDx CLIA waiver study in the US, with the first patient successfully tested

• FebriDx is a rapid, point-of-care test to aid in the differentiation between bacterial and non-bacterial acute respiratory infections

• Official study commencement triggers first two milestone payments under Lumos’ BARDA partnership, valued at US$925,217

Special Report: Lumos Diagnostics (ASX:LDX) has announced its FebriDx point-of-care clinical laboratory improvement amendments (CLIA) waiver study in the US has officially started, with the first patient successfully tested.

FebriDx is a unique, rapid point-of-care (POC) test that uses a fingerstick blood sample to aid in the differentiation between bacterial and non-bacterial acute respiratory infections.

Lumos said knowing whether a patient has a bacterial infection has a direct impact on reducing unnecessary antibiotic prescriptions, limiting the spread of antibiotic-resistant bacteria, and helping providers know when to initiate antibiotic treatment.

CLIA waivers are granted by the US Food and Drug Administration (FDA) and allow certain diagnostic tests to be performed in non-laboratory settings, such as doctors’ offices, urgent care centres, and pharmacies, by individuals who are not trained laboratory personnel.

The tests are considered simple and pose a low risk of incorrect results.

Lumos noted the study would evaluate the use of the FebriDx device by untrained users in multiple CLIA-waived clinical sites across the US, adding that between 500 and 800 patients were expected to be enrolled to achieve the required 120 positive bacterial cases necessary for the study.

The study is forecasted to run through the forthcoming US spring season of 2025, after which a formal submission will be prepared for the FDA.

Study triggers BARDA funding

Lumos has partnered on the CLIA waiver study with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response.

BARDA is providing US$2,984,571 in non-dilutive funding to support the waiver study and FDA application, as well as regulatory, technical, and clinical expertise in support of the FebriDX POC test.

Lumos said the first two milestones under the funding initiative have now been achieved. The first, related to study preparation and launch, is valued at US$596,914, and the second, for enrolling the first patient, is US$328,303.

The company has now submitted invoices to BARDA for these amounts, totalling US$925,217, and expects payment by the end of January 2025.

US$1.7 billion opportunity

At the conclusion of the study, Lumos hopes to achieve a successful reclassification of FebriDx from moderate complexity to a CLIA-waived device.

The company said this would significantly increase its market reach in the US, with the total addressable market expanding 15-fold from 18,000 to around 270,000 potential customer sites, unlocking a potential market opportunity valued at ~US$1.7 billion annually.

“We are very pleased to commence this pivotal clinical study, particularly with BARDA's  invaluable support,” said Lumos managing director Doug Ward.

“Achieving CLIA-waived status would enable FebriDx to reach a broader market and empower healthcare providers with a reliable tool for delivering accurate and objective health insights to their patients,” he added.

This article was developed in collaboration with Lumos Diagnostics, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Originally published as Lumos starts ‘pivotal clinical study’ in US for point-of-care respiratory test