NEW YORK ─ Like many other in vitro diagnostic test developers, London-based LumiraDx saw an opportunity when the COVID-19 pandemic led to a surge in demand for decentralized testing.
So, it struck while the iron was hot, ramping up its commercialization efforts while also going public on the Nasdaq.
During the pandemic, LumiraDx launched its point-of-care instrument and first commercial assays — including antigen, molecular, and antibody tests to detect SARS-CoV-2 — and last week it launched its initial public offering following a merger that valued it at $3.0 billion.
According to Brian DuChateau, vice president of scientific and clinical affairs at LumiraDx, the pandemic enabled "us to get our products into the market quickly through [US Food and Drug Administration] Emergency Use Authorizations," allowing the company to "put our technology into the hands of users, who for the first time could see the kind of analytical and clinical performance they can expect from tests running on our platform."
In doing so, LumiraDx joins a crowded market for decentralized tests, which includes established firms as well as other new entrants.
Founded in 2014 by a group of entrepreneurs that include former executives of Medisense and Abbott's Alere, LumiraDx went public after merging with CA Healthcare Acquisition, a special purpose acquisition company.
DuChateau said that proceeds from its initial public offering are unlikely to alter its commercial plans but they "will enable us to continue on our journey of building out our test menu." Dozens of tests have performed well on its platform in feasibility studies, and a shorter list of them are in active R&D, he said.
The company has five tests on the market and anticipates regulatory submissions or clearances for 10 additional assays within the next two years, including for troponin, flu/COVID, and tuberculosis. It has CE marking and FDA EUAs for its COVID-19 antigen and antibody tests, and it is marketing CE-marked INR, D-dimer, and COVID-19 pooling tests in Europe.
DuChateau explained that in the near term, the company expects to broaden its menu for US customers by launching the D-dimer assay, used to detect blood clotting disorders, and an INR assay, used to guide anticoagulation treatment, on the back of FDA clearances. Before the end of this year, it plans to apply to the FDA to obtain an EUA for a tripleplex antigen test that detects and differentiates SARS-CoV-2, influenza A, and influenza B.
All going to plan, the tripleplex test will be in the market in time for the forthcoming US flu season, DuChateau said.
The point-of-care testing firm is also developing a broader range of assays for hematology, coagulation, and infectious disease applications that employ immunoassay, molecular, or antigen testing modalities in different applications.
By the time of its IPO, the company had shipped more than 15,000 platforms globally and was rolling out tests in more than 90 countries for use in traditional decentralized settings, such as physician offices, and less traditional settings, such as cruise ships and oil rigs.
CVS Pharmacy in the US; the National Health Service and Boots in the UK; accident and emergency rooms in Italy and other parts of Europe; and hospital systems in Japan and South America are deploying its instruments and tests, the firm said.
The firm's RNA Star Complete rapid nucleic acid amplification assay, for which it obtained US FDA EUA in 2020, is being used for testing by schools in about 25 US states, and its point-of-care antigen test is being used by schools in Italy. Through a partnership with the Bill & Melinda Gates Foundation, its instruments and tests are available in 49 African countries.
Its microfluidic-based platform — which provides results in about 12 minutes from sample introduction — is the foundation for all its tests and their applications, and provides differentiation for the company in the IVD market, DuChateau said.
Its technology was a central element of a virtual presentation by DuChateau last week at the 2021 AACC Annual Scientific Meeting & Clinical Lab Expo.
He said during the presentation that the architecture of the microfluidic platform is a central component of addressing traditional challenges to the adoption of point-of-care tests. The platform "is extremely flexible and can be changed to accommodate many different types of reactions and reaction characteristics," DuChateau said during his presentation. "For instance, we can change the amount of reagents that are deposited within reaction zones … [and] the lane architecture to accommodate different volumes of reactions and different reaction conditions."
The test strip architecture changes with each assay, he said, adding that the design needed for its INR test "is very different" from that needed for its infectious disease assays.
The microfluidic technology also enables the precise movement of small specimen volumes around the internal architecture of each test strip, enabling performance advantages over current antigen and antibody tests that use lateral flow technology, DuChateau said, adding, "With microfluidics, we're precisely controlling temperature of the reaction, time of the reaction, how the reaction is mixed and washed, magnetic particle manipulation and separation, and spectrophotometric reads — all things that you might expect to find on a conventional lab-based analyzer but in a miniature or microfluidic format."
Because its miniature test mirrors many of the processes conducted by larger laboratory platforms, the performance "you get from the instrument and platform are similar to the analytical and clinical performance of clinical lab analyzers," DuChateau said.
The LumiraDx SARS-CoV-2 antigen test, an immunoassay for the qualitative detection of the SARS-CoV-2 nucleocapsid antigen, is authorized for use in symptomatic patients for 12 days from symptom onset, using a nasal or nasopharyngeal swab specimen. In a clinical trial conducted to obtain EUA that included six healthcare facilities — five in the US and one in the UK — all subjects were symptomatic and presented within 12 days of symptom onset. The LumiraDx test showed 96.9 percent overall concordance with a comparator RT-PCR assay, including 97.6 percent sensitivity and 96.6 percent specificity, the firm said in documents filed with the FDA.
The LumiraDx antigen test also outperformed three lateral flow antigen tests in a clinical study conducted from January to March this year, William Clarke, a professor of pathology at Johns Hopkins University School of Medicine, said during the presentation hosted by LumiraDx at AACC.
The test had an 88 percent sensitivity and 100 percent specificity in an evaluation of asymptomatic and symptomatic individuals for SARS-CoV-2 conducted this year by Johns Hopkins healthcare professionals, said Clarke, who is an adviser to LumiraDx. He added that Johns Hopkins also evaluated the performance of three lateral flow SARS-CoV-2 assays for a mix of symptomatic and asymptomatic patients and found that the levels of sensitivity ranged from 33 percent to 52 percent.
"For me, the clear distinction is that the other kits were lateral flow assays," and each had a low clinical sensitivity in the study, while the LumiraDx test had "strong sensitivity and specificity," Clarke said in an interview.
Still, when a high-performing point-of-care test is available, the decision to implement it is not straightforward and requires decisions about the availability of resources, pricing, and whether the instrument's throughput can match the number of tests that need to be completed.
People need to be appointed to oversee specimen collection, run the test, and complete the documentation and quality assurance protocols, which can curtail adoption when many healthcare entities "are struggling with staffing," Clarke said.
The total cost of ownership of a point-of-care test is another point to consider and, historically, has been a challenge to adoption, DuChateau noted. "People have tooted the point-of-care horn for a long time, but its benefits have not been fully realized for a lot of reasons," he said. "We're cognizant of that and actively trying to rectify it."
The firm's automated production lines enable it to reduce costs and manufacture a few million test strips per week, DuChateau said. The manufacturing lines can be retooled quickly to produce new tests as needed, and the small test strips that are consumables for its instrument have low materials costs. Overall, such cost reductions are "a key differentiator" for the LumiraDx platform and tests, DuChateau said, adding that some of the firm's point-of-care tests are priced at $4 apiece.
Unlike some SARS-CoV-2 lateral flow antigen assays, however, the LumiraDx tests require an instrument. Clarke noted that, in general, a point-of-care "instrument like this will typically cost in the range of $5,000 to $8,000."
LumiraDx said it is not disclosing the specific price of its instrument but that it is below the typical range, and it offers reagent rental models where the instrument is placed free of charge.
The company's instrument can perform four or five tests per hour, Clarke said, noting that a bank of instruments would be needed for large-scale screening.
As a result, the instrument may be best suited where lower volumes of tests are needed, such as surgery centers prepping patients for procedures, the monitoring of employee health, or clinics that have a few instruments at their disposal, Clarke added.