NEW YORK – With nearly $10 million in recent contracts and financing, and new distribution agreements in place, Australian infectious disease company Lumos Diagnostics hopes to obtain CLIA waiver for its FebriDx rapid host-response test next year to catalyze its US expansion.
This week, Lumos announced a $3 million contract from the Biomedical Advanced Research and Development Authority (BARDA), with a total potential contract value of $8.3 million. Lumos also announced a A$10 million (US$6.8 million) equity raise in September.
"Folks are realizing that FebriDx is scalable and is something that can be available to the masses," said Paul Kase, Lumos' senior VP of commercial operations, noting that the new funding will support studies needed to obtain CLIA waiver for the test.
A 10-minute assay to distinguish bacterial and nonbacterial infections, FebriDx is positioned to reduce inappropriate prescribing of antibiotics, which has led to antimicrobial resistance throughout the world.
The disposable test detects two human biomarkers — C-reactive protein (CRP) and myxovirus resistance protein A (MxA) — from a fingerstick blood sample. It integrates a small lancet with a lateral flow test strip and boasts 99 percent accuracy in ruling out bacterial infections.
Lumos has intellectual property covering the use of MxA, the combination of CRP and MxA, and threshold levels used to determine a positive result.
Opportunities
Incorporated in Carlsbad, California, by a holding company based in Melbourne, Australia, Lumos raised approximately A$63 million through its IPO on the Australian Securities Exchange in 2021. This was preceded in 2020 by a pre-IPO raise of nearly A$25 million and a $15 million Series A funding round.
Earlier this year, Lumos projected the market opportunity for FebriDx to be more than $1 billion.
FebriDx has regulatory clearance in 17 countries, Kase said, including the UK, various countries in Europe, the United Arab Emirates, Turkey, Pakistan, Singapore, Malaysia, Australia, and New Zealand.
After having its first US submission denied in 2022, FebriDx was granted 510(k) clearance by the US Food and Drug Administration in July 2023 for use in high- and moderate-complexity settings. Lumos also obtained Emergency Use Authorization in September 2023 for a 15-minute combined COVID-19/Flu A/Flu B test called ViraDx and launched both tests in the US that year.
Fiscal year 2024 sales of FebriDx, ViraDx, and test readers in the US, UK, and Europe nearly quadrupled over the prior fiscal year, from approximately $300,000 to $1.2 million. The company believes CLIA waiver could potentially grow the market for FebriDx 15-fold, from approximately $118 million to $1.7 billion.
The firm's US customer base is also expanding. A national contract with MediGroup last month will make FebriDx available to 30,000 moderately complex labs and CLIA-waived locations, and Lumos said it has forged 26 similar partnerships in fiscal year 2024.
Surprisingly, the most immediate impact came from the university student health market. "Those clinics were spending so much time fielding phone calls from concerned parents asking why their child wasn't getting an antibiotic," Kase said. Student health clinics at large universities often have dedicated labs, in part to prevent on-campus outbreaks, he noted, and with 99 percent negative predictive value, FebriDx can help these labs support clinical decisions.
To support its CLIA waiver submission, Lumos plans to embark on a multicenter method comparison study between untrained and trained operators this month, conducted in collaboration with a contract research organization at physician offices and standalone urgent care clinics and enrolling approximately 500 to 900 patients. Submission for CLIA waiver is expected in mid-2025 and potential waived status as early as September 2025.
Lumos also signed 19 new partnerships and three distribution agreements for ViraDx in fiscal 2024. It also expanded a prior distribution partnership with Henry Schein for FebriDx to include additional countries, and it partnered with Thermo Fisher Scientific's Thermo Healthcare last month for distribution in the US.
In addition, Lumos secured distribution rights for Binx's CLIA-waived point-of-care chlamydia and gonorrhea test system last year.
Lumos expects to compete with host-response tests from firms like MeMed, Inflammatix, Immunexpress, or Biomeme and potentially with rapid syndromic assays to detect and distinguish infections from developers like T2 Biosystems or BioMérieux. With a price of $21 per instrument-free test, a CPT code, and a $29.55 reimbursement rate, FebriDx may have some cost advantages, Kase suggested.
Studies and services
A handful of studies in the past few years have validated the utility of FebriDx. A 2022 evaluation of the test among outpatients with acute respiratory infections, for example, found that incorporating it into clinical decision-making could reduce overprescribing.
In comparison to a diagnostic algorithm, the test had a sensitivity of approximately 93 percent and a negative predictive value of approximately 99 percent to detect and rule out bacterial-associated host immune responses. It also had a specificity of 88 percent and a PPV of approximately 90 percent to detect viral-associated immune responses. And, the test detected all microbiologically confirmed bacterial infections with a sensitivity and an NPV of 100 percent. However, it showed a positive predictive value of only 58 percent indicating it was less good at predicting culture positivity.
Annie Bell, Lumos' director of medical affairs, noted that FebriDx is meant to serve as an adjunct to clinical assessment to guide treatment strategies, and that the low PPV may reflect an existing tendency to overprescribe antibiotics.
Another evaluation, published in June, showed FebriDx could lead to a 40 percent reduction in inappropriate antibiotic prescriptions for lower respiratory tract infections.
Notably, an economic evaluation of FebriDx published three years ago by Avalon Health Economics projected $2.51 billion in annual savings in the US were FebriDx to be widely adopted to guide antibiotic prescribing.
In addition to its point-of-care diagnostics business, Lumos also offers test development services. It recently inked two agreements with Hologic related to that firm's QuikCheck fFN preterm birth risk assay to detect fetal fibronectin, which Lumos has said has an addressable market of 2.5 million tests per year. In January, Lumos provided Hologic with an exclusive license to its reader and point-of-care technologies in the field of fetal fibronectin in a $10 million deal. Lumos also signed a development agreement with Hologic valued at up to $4.7 million for prototype delivery.
For its service business, Lumos develops assays at its Carlsbad facility, either on a single-use disposable reader with an integrated test strip or a multiuse disposable reader with kits of disposable tests. It can develop assays on two other readers, including one it calls Leelu for research or quality control testing, as well as on a handheld reader.
According to its annual report, the firm expects to expand the service aspect of its business into food and environmental testing and to broaden its assay development capabilities to include novel point-of-care technologies and molecular diagnostics.