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Lumos Diagnostics’ strong full-year results boosted by FDA clearances and strong distribution partnerships

Published 27/08/2024, 12:20 pm
© Reuters.  Lumos Diagnostics’ strong full-year results boosted by FDA clearances and strong distribution partnerships
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Lumos Diagnostics Ltd (ASX:LDX, OTC:LDXHF) has revealed its full-year results for the 2024 fiscal year, in which the company recorded revenue of US$11.1 million, up 6% on the prior year (US$10.5 million).

Lumos hit product revenue of US$1.2 million, up a whopping 289% on the prior year, and commercial services revenue of US$9.9 million.

The company’s cash position at the end of the year was US$6.5 million and it delivered positive net operating cashflow of US$900,000 for the year.

What’s more, Lumos is now debt-free and boasts a healthy cash balance thanks to a successful US$5 million capital raise – net of costs – in equity capital and redeemed in full the convertible notes during the year.

Women’s health

During the year, Lumos struck two ‘transformative’ agreements with leading women’s health company, Hologic, for a combined total of US$14.7 million.

The partnership is committed to advancing women’s health, specifically targeting the development of an improved version of Hologic’s on-market Fetal Fibronectin (fFN) test, a diagnostic tool for pre-term pregnancy.

This test is being modernised and will be adapted for use with Lumos’ proprietary reader platform. The two new agreements involve the development of custom reader and point-of-care technologies.

The collaboration with Hologic made a strong contribution to revenue during the second half of the year through revenue from the intellectual property agreement and the completion of Phase 1 development work.

FDA go-ahead for point-of-care tests

In July 2023, Lumos received US Food and Drug Administration (FDA) clearance to market FebriDx®, a rapid point-of-care test.

FebriDx® aids healthcare professionals in diagnosing bacterial acute respiratory infections and differentiating them from non-bacterial causes in urgent and emergency care settings.

In September of that year, the company bolstered its diagnostic offerings by obtaining Emergency Use Authorization and a CLIA Waiver from the FDA for its ViraDx® test.

This rapid point-of-care test detects COVID-19, Flu A and Flu B from nasal swab samples, and provides results in just 15 minutes.

The regulatory clearances free the company to scale up commercial activities at its California facility to meet the anticipated demand ahead of flu season in the US.

During the year, Lumos expanded its partnership with Henry Schein (NASDAQ:HSIC), a leading global provider of healthcare solutions.

As of July 2024, Henry Schein distributes FebriDx® to the United Kingdom, Portugal, Spain, the Netherlands and the United States, with Belgium, Australia and New Zealand added more recently.

Priorities on the horizon

CEO and managing director Doug Ward said: "Our strong financial performance in the second half of the year is testament to the solid foundations we've laid over the past 18 months.

“As we move into FY2025, our priorities are clear: successfully delivering our FebriDx® and ViraDx® products for the upcoming northern hemisphere flu season, advancing the FebriDx® CLIA waiver study, and fulfilling key milestones under our development agreement with Hologic.

“We will also be actively pursuing new strategic partnerships in the point-of-care market segment.

“My thanks go to our Lumos team, shareholders, partners, customers, and board who provided us with strong support through FY2024. We look forward to continuing to progress the tremendous potential within Lumos through the current financial year."

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