• Lumos partners with MedPro for national contract sales coverage of FebriDx across hospital and primary care markets in US
• FebriDx is a point-of-care diagnostic test to distinguish between bacterial and non-bacterial respiratory infections
• Partnership expected to increase awareness and adoption of FebriDx, enhancing its accessibility across the US

Special Report: Lumos Diagnostics has partnered with MedPro Associates to provide national contract sales in the US for its rapid point-of-care (POC) FebriDx test that aids in differentiation between bacterial and non-bacterial acute respiratory infections.

Lumos Diagnostics (ASX:LDX) said MedPro would offer contract sales coverage across the health system, government and physician offices in the US and serve as an extension of its sales force with more than 60 territory reps strategically positioned across the country to increase FebriDx awareness and adoption.

Under the partnership, MedPro will also provide customer-lead generation, sales revenue, and customer training for FebriDx with the collaboration expected to make an immediate impact on Lumos’ US footprint.

Lumos said MedPro’s reach into acute care encompasses both the US hospital environment and the US federal government including Department of Defense, Veterans Affairs, Department of Health and Human Services – Indian Health Services and Federal Bureau of Prisons hospitals.

The company said the MedPro team builds relationships with decision makers and drives successful product conversions for enhanced patient care.

In the non-acute care setting, MedPro services Physician Offices, Ambulatory Surgery Centers, Skilled Nursing Facilities, and Home Health Agencies.

CLIA waiver study underway

Lumos announced in December its FebriDx point-of-care clinical laboratory improvement amendments (CLIA) waiver study in the US had officially started, with the first patient successfully tested.

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 said 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.

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.

At conclusion of the study, which is forecast to run through the US spring season of FY25, Lumos hopes to achieve a successful reclassification of FebriDx from moderate complexity to a CLIA-waived device.

Tackling overuse of antibiotics

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 this was a critical capability, given that most acute respiratory infections stem from viruses and do not require antibiotics yet are prescribed in up to 50% of such cases, contributing to the growing issue of antibiotic resistance.

The company said the US faces significant challenges in this area, with antibiotic resistance leading to ~2.8 million illnesses and 35,000 deaths annually.

“We are thrilled to be working alongside the Lumos team and supporting their products across all major medical markets, as the partnership will undoubtedly help patients and caregivers alike with fast, accurate assessments of various conditions facing patients here in the USA,” MedPro CEO Bill Sparks said.

Lumos CEO and managing director Doug Ward said the company was thrilled to be working alongside MedPro to bring FebriDx products to the US market.

“Their familiarity with US healthcare markets coupled with their strong customer relationships and business development expertise makes them an excellent partner,” he said.

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.