NEW YORK ─ Lumos Diagnostics is using proceeds from its recent initial public offering to expand its respiratory test portfolio, adding new assays that are complementary to FebriDx, its flagship single-use assay for detecting and differentiating viral and bacterial infections, and determining whether an infection is present or not.
The company is using some of the funding from its A$63 million ($46.9 million) IPO on the Australian Securities Exchange in July to prepare for the launch of two new lateral flow antigen tests — a rapid test for SARS-CoV-2, called CoviDx, and a multiplex test to differentiate SARS-CoV-2 from influenza A and B, called ViraDx.
Earlier this week the Melbourne, Australia-based company said it booked A$25 million for fiscal year 2021, almost double the revenue it reported for the prior year. It booked A$2.3 million in sales of FebriDx, a point-of-care, lateral flow assay that uses a fingerprick of blood and operates without an instrument while providing results in 10 minutes.
In fiscal 2021, Lumos reported sales for the assay in the UK, Germany, and Canada, and anticipates booking its first US sales for the product in fiscal 2022 if it is successful in getting regulatory clearance from the US Food and Drug Administration.
The firm recently completed a pivotal clinical study for FebriDx and applied for 510(k) clearance and CLIA waiver from the FDA to enable its launch in the US.
The booking of its first meaningful revenues for FebriDx reflects a strategic shift to a more diverse mix of revenues and an increased focus on the development, manufacturing, and sale of Lumos-branded diagnostic testing products for use at the point of care, the firm's CEO Rob Sambursky said in an interview.
Funding from the IPO is predominantly supporting preparations for the US commercial launch of FebriDx, which combines two biomarkers for detection — myxovirus resistance protein A, or MxA, and C-reactive protein — and consists of a built-in lancet to pierce the skin, a built-in blood collection and transfer tube, and push-button activation.
Though FebriDx has clinical utility for hospital emergency departments, Lumos' primary sales targets will be outpatient centers such as physician offices and urgent care centers, Sambursky said.
The company initially developed FebriDx for use as a triage test in hospital outpatient settings, partly to help clinicians quickly identify a bacterial infection requiring an antibiotic and to prevent a serious bacterial infection or sepsis.
The test gained traction during the pandemic because it quickly detects the presence of a viral infection, enabling the isolation of a patient and, if needed, a confirmatory test for SARS-CoV-2, influenza, or another condition, Sambursky said, adding that the test can also "rule out an infection in people who are symptomatic and may be in a post-infectious or convalescent state, so they can get back to work, school, or day care."
Diagnostic testing companies have developed a broad range of laboratory and point-of-care assays to detect and diagnose acute respiratory infections and determine whether a medical condition is bacterial or viral, and Lumos is looking to address market demand for affordable tests that help clinicians make quick decisions about a patient presenting with symptoms.
"Lumos’ progress is further proof that the host response is a major growth category for infectious disease diagnostics," Tim Sweeney, cofounder and CEO of Inflammatix, said in an interview. "FDA clearance, if granted, will certainly [maintain] this trend," he added.
Burlingame, California-based Inflammatix is developing a point-of-care assay ViraBac EZ that detects gene-expression patterns in the immune system to identify whether a suspected infection is bacterial or viral.
Sweeney noted that FebriDx uses lateral flow rather than a molecular approach to detecting the host response. As a result, the assay "certainly could experience the same benefits and challenges of lateral-flow antigen assays compared to molecular assays in other areas like influenza and COVID," Sweeney said.
Though lateral flow assays can be cheap and quick, they are also subject to concerns about accuracy. However, "the pathogen-testing market has grown to accommodate both approaches, and perhaps that will be the case with host response, as well," Sweeney added.
Last year, during the first wave of the COVID-19 pandemic, investigators from University Hospital Southampton and the University of Southampton in the UK evaluated the accuracy of FebriDx in a study involving 251 patients who had been hospitalized with suspected COVID-19. The researchers published the results in the Journal of Infection, saying the assay detected MxA in 10 minutes with 93 percent sensitivity and 86 percent specificity compared to PCR and "could be used as a rapid front door triage tool in hospitals."
An earlier 2017 study published in the Journal of Clinical Medicine included 205 patients and reported that FebriDx had a 97 percent negative predictive value for bacterial infection and 95 percent negative predictive value for viral infection.
Lumos' prospective clinical trial to obtain FDA clearance for FebriDx enrolled 690 patients at 20 US clinical sites that included hospital emergency departments and urgent care and primary care sites. "It's a robust study that we believe demonstrated the ability to differentiate viral and bacterial infection with significantly good clinical performance, and it exceeded all of the predetermined FDA criteria for" clinical performance, Sambursky said.
As the firm awaits the FDA decision, Lumos has a portfolio of new point-of-care diagnostic tests that are complementary to FebriDx and that it intends to start selling in the US, Sambursky said.
The company launched its 15-minute turnaround CoviDx SARS-CoV-2 antigen test in the spring, having obtained CE marking in February. The rapid antigen test targets the SARS-CoV-2 nucleocapsid protein, and Lumos has applied to the US FDA for Emergency Use Authorization.
As the comparator assay during the clinical trial for CoviDx, Lumos used PerkinElmer's RT-PCR SARS-CoV-2 test which had received FDA EUA in April. "We showed that CoviDx had 100 percent sensitivity for [cycle threshold] values up to 35, and a 95 percent specificity, even at a time of low relative COVID-19 prevalence," Sambursky said, adding that the firm also demonstrated the test "works across all the variants" including Delta.
Sambursky added that ViraDx will be available in the second half of fiscal year 2022, pending CE marking and FDA EUA, enabling its use during the winter flu season early next year. Lumos will pursue IVD Regulation, or IVDR, approval for all products it sells in Europe, he said.
FebriDx, CoviDx, and ViraDx can be deployed when triaging is needed for patients suspected of acute respiratory infection. FebriDx can be used to quickly detect whether an infection is bacterial or viral, or whether there is no infection. If an infection is confirmed as viral, either CoviDx or ViraDx can be applied as needed for confirmation, Sambursky said.
To support the US launch of FebriDx and other assays, the firm is hiring an internal sales team and will use a hybrid direct sales and distributor sales strategy to target customers.
It currently partners with in-country distributors outside the US, and in March Lumos announced a Canadian distribution agreement for FebriDx with Winnipeg-based Northern Diagnostics.
Lumos' decision to host an IPO on the Australian Securities Exchange stemmed from its corporate history. In 2017, Lumos was spun out as an independent company by Melbourne-based Planet Innovation and merged with Sarasota, Florida-based Rapid Pathogen Screening in 2019, retaining the Lumos Diagnostics name. RPS, at the time, developed and manufactured point-of-care diagnostic tests, while Lumos was a full-service point-of-care diagnostic development firm.
Lumos said that it received financial support from a group of Australian institutional investors after the merger, which included their participation in a pre-IPO raise of A$25 million in 2020 and investments during the IPO — a key factor in the company selecting the Australian Securities Exchange as a venue for the offering.
The firm is using some of the IPO funds to invest in R&D and its manufacturing facilities so that it "can continue to drive the business forward with a robust pipeline, and shift some of our service business into contract manufacturing," Sambursky said.
To facilitate an expected increase in production demand, Lumos has expanded manufacturing capacity to 10 million tests per month. It does the bulk of its high-volume manufacturing in Sarasota and pilot scale manufacturing in Carlsbad, California, working with companies looking to produce both small and large volumes of tests.
Longer-term Lumos is developing additional products including UriDx to detect urinary tract infections and SepsiDx to detect sepsis, as well as readers for future generation products. The availability of readers would enable Lumos to "move into settings where people care about connectivity and connecting to the cloud or electronic health record systems … and may open doors to at-home testing or over-the-counter testing in the future," Sambursky said.
UriDx will use biomarkers to detect bacterial infection in urine, and SepsiDx will use biomarkers that are hallmarks of patients progressing to sepsis, Sambursky said, adding that he is not yet disclosing the types of biomarkers or specific biomarkers for either test. He anticipates that both products will be on the market with regulatory approvals within two to three years.
An important feature for all of its tests, current and future, is affordability, he said, adding that FebriDx can be purchased for about $25 per test, and the company intends to seek reimbursement for the test if it is cleared by the FDA.