Lumos inks groundbreaking US funding deal to support critical study for point-of-care respiratory test

Lumos Diagnostics has been awarded almost US$3.0m in US Government funding – as part of a milestone-bound deal worth > US$8M – to support its FebriDx test to differentiate bacterial from viral respiratory infection.

Lumos is making strides with its now FDA-cleared FebriDx point of care test that helps to differentiate bacterial from viral infections. Pic: Getty Images.

• Lumos awarded ~US$3m in non-dilutive funding from BARDA in US to support upcoming FebriDx CLIA waiver study and US FDA application.

• This world-first point-of-care test helps doctors differentiate a bacterial from viral respiratory infection – a critical diagnostic insight which determines the need for antibiotics – within 10 minutes or less.

• Lumos said FebriDx is a powerful diagnostic tool that is ideally placed to reduce the over-prescription of antibiotics and the pressing global emergency of antimicrobial resistance (AMR).

 

Special Report: Rapid point-of-care diagnostic technologies company Lumos Diagnostics (ASX:LDX) has been awarded US$3m in non-dilutive funding via a US Government grant to support a CLIA waiver study and US FDA regulatory submission for its test to differentiate a bacterial from viral respiratory infection.

Lumos Diagnostics (ASX:LDX) said it has been awarded US$2,984,571 from BARDA, part of the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response, to support the upcoming FebriDx CLIA waiver study and US FDA application.

LDX said the total contract value if all options were exercised was much more at  US$8,258,774 – a significant source of undiluted, de-risking capital for the Company.

The FebriDx point-of-care test is a visually read, all-in-one, integrated, single-use test designed to assess whether an acute respiratory infection is bacterial or non-bacterial in origin in the US, and bacterial or viral in other markets where the product has been cleared by regulatory bodies.

FebriDx qualitatively detects elevated levels of two proteins produced by the body’s immune response, which help differentiate between bacterial (C-reactive protein ) and non-bacterial (Myxovirus resistance protein A ) infections in a fingerstick blood sample.

LDX said the test currently has FDA 510(k) clearance for moderate and high-complexity use settings, but was looking to expand its use through a CLIA waiver. With the end goal, to put it into the hands of more people eager to quantify (with evidence) whether antibiotics are needed – or not.

The test provides results in about 10 minutes with faster results for bacterial or non-bacterial infections helping doctors make more informed decisions about patient treatment, potentially reducing inappropriate antibiotic use.

BARDA to support vital clinical study

Under the partnership, BARDA will support LDX’s planned clinical study, comparing test usage among untrained users in CLIA-waived settings to trained users, and will provide regulatory expertise for the submission to obtain a CLIA waiver from the FDA.

LDX said waived tests include test systems that are simple to use and have a low risk for erroneous results.

The Company said the partnership has the potential to impact patient care by expanding testing to CLIA-waived, POC settings, including physician offices, urgent care clinics, and other outpatient clinics.

LDX said the project had been funded in whole or in part with Federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response and Biomedical Advanced Research and Development Authority.

‘Powerful diagnostic tool’

LDX CEO and MD, Doug Ward, said doctors have relied primarily on clinical observation to determine whether patients require antibiotics for acute respiratory conditions.

“FebriDx is a powerful diagnostic tool that can provide a quick and clear clinical evaluation, reducing the over-prescription of antibiotics,” he said

“We are honoured to partner with BARDA on the CLIA waiver study and regulatory submission for FebriDx.

“BARDA’s expertise and funding will support our goal of expanding the test's utility from its current use in moderate and high-complexity labs, to US CLIA-waived point-of-care settings, including physician offices, urgent care clinics, and other outpatient clinics.

Ward said achieving this goal would greatly expand FebriDx’s ability to improve antibiotic stewardship.”

He said the non-dilutive funding received under the BARDA contract would complement funds raised under the entitlement offer recently open to LDX shareholders.

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 inks groundbreaking US funding deal to support critical study for point-of-care respiratory test