Lumos Diagnostics Holdings Pty. Ltd. scooped up AU$25 million (US$17.9 million) in an oversubscribed pre-IPO ahead of its anticipated 2021 listing on the Australian Securities Exchange (ASX). The funds will be used to expand manufacturing operations in California and Florida and to grow the commercial footprint of Febridx, a rapid point-of-care (POC) test that can determine if a person has a viral or bacterial infection within 10 minutes.

Institutional investors, including Perennial Value and Ellerston Capital, participated in the raise, along with sophisticated investors, many of whom have previously backed Lumos. It follows a $15 million series A earlier this year led by Australia’s Planet Innovation.

A spinoff of Planet Innovation, Lumos Diagnostics merged with Rps Diagnostics, a Florida-based commercial diagnostic developer, manufacturer and marketer of POC tests in 2019. The combined company took the name of Lumos Diagnostics.

Since then, the Melbourne, Australia-based company has raised a total of about $28 million, including the pre-IPO.

“Depending on market conditions, Lumos anticipates an ASX listing in mid-2021,” Rob Sambursky, Lumos Diagnostics’ president and CEO, told BioWorld.

Febridx is a rapid POC test that provides clinicians with an in-office assessment of the body’s immune response to acute respiratory infection (ARI). Roughly half of all unnecessary antibiotic prescriptions are for outpatient ARIs that may be associated with nonspecific flu-like symptoms, including fever, sore throat, cough, nasal congestion and fatigue.

From a fingerstick blood sample, the single-use test identifies patients who have a clinically significant underlying infection and helps to differentiate viral versus bacterial ARIs via the simultaneous detection of Myxovirus resistance protein A and C-reactive protein.

COVID-19 impact

The fresh injection of capital comes as rapid POC diagnostics are in high demand worldwide to address testing and containment needs in the COVID-19 pandemic. This has resulted in a big market opportunity for Lumos Diagnostics’ product.

“The COVID-19 pandemic has led to increased adoption of the Febridx test, because it can help to quickly triage patients with a Febridx viral positive result that require PCR confirmation or SARS-CoV-2 and encourage them to maintain social isolation until the PCR results are returned,” Sambursky explained. “Febridx can also be paired with a rapid antigen test to help identify antigen negative/Febridx viral positive patients that may benefit from PCR.”

While the test was designed for outpatient use, the pandemic has fueled hospital adoption as many asymptomatic patients are visiting the emergency room instead of their primary care doctor.

The pandemic has spurred Lumos’ growth in other ways, too. The company is partnering with several companies, including some that are participating in NIH’s Rapid Acceleration of Diagnostics program, to develop both COVID-19-specific rapid antigen and antibody tests.

The U.K.’s national Institute of Health Research has also shown real-world benefit of Febridx as a frontline triage tool to aid in managing patients suspected of having COVID-19. In two U.K. studies, Febridx demonstrated 93%-99% sensitivity for identifying a viral infection in patients with the novel coronavirus and a 99% negative predictive value for ruling it out, even at low disease prevalence.

Countries outside the U.S. are using Febridx as a “front door triage test” to quickly identify bacterial from viral infection, Sambursky said.

He added that feedback on the test has been positive, as clinicians can use it not only to triage patients for a confirmatory test but also to prioritize confirmatory testing.

Global footprint, pivotal trial

As of now, the test is available in Europe, Canada, Australia, Saudi Arabia, Pakistan, Singapore and Malaysia.

“The increased adoption, expanded market opportunity to include inpatient testing and the benefit of identifying bacterial infections requiring antibiotic therapy while reducing unnecessary antibiotic prescriptions should position the Febridx test for sustainable growth even after the pandemic improves,” Sambursky said.

The company is currently working to get U.S. FDA clearance of Febridx. Its DISRUPT pivotal trial was about halfway enrolled when COVID-19 interrupted the study. It will resume next month, with an FDA submission to follow upon completion.

“Rapid diagnostics is a developing sector internationally, and to have a really strong and growing service business, complemented by a product business with huge potential – it was too good an investment to pass up,” said David Keelan, portfolio manager at Ellerston Capital and a first-time Lumos investor.

A portion of the funds from the pre-IPO are earmarked for construction at Lumos Diagnostics’ Sarasota, Fla., and Carlsbad, Calif., sites. Combined, the two facilities account for about 17,000 square feet and support both R&D and manufacturing.

In Sarasota, the company is building out a new 32,000-square-foot facility with potential for expansion. The state-of-the-art facility will include an expanded biosafety level 2-dedicated R&D laboratory, climate-controlled manufacturing laboratory and dry rooms to accommodate expansion of automation, as well as substantial warehousing space. Similar plans are being explored for Carlsbad in early 2021.

Sambursky said the expanded facilities will have the added benefit of allowing teams to work in a more physically distanced manner, in line with current COVID-19 workplace safety precautions.

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