NEW YORK – Australian diagnostics firm Ellume is preparing to make its entrance into the US market with the launch of three tests for SARS-CoV-2.
Backed by $30 million in funding from the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) initiative and the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority's (BARDA), Ellume is developing a SARS-CoV-2 antigen test in collaboration with Qiagen, as well as a point-of-care antigen test and at-home rapid antigen test that it is producing independently.
The test Ellume is developing with Hilden, Germany-based Qiagen stems from an ongoing collaboration between the companies aimed at using Ellume's digital sensing technology to build a portable version of Qiagen's QuantiFeron-TB Gold Plus assay for latent tuberculosis detection using Qiagen's QiaReach test system (formerly known as the QFT Access), which consists of a lateral flow test cartridge the company called an eStick and an eHub reader. The companies began working on the assay in 2016 and were nearing a launch when the SARS-CoV-2 pandemic hit, said Sean Parsons, East Brisbane-based Ellume's founder, managing director, and CEO.
"When COVID came up, we said with Qiagen that we should put COVID products on that format, as well," Parsons said.
The parties previously developed a SARS-CoV-2 serology test for use on the QiaReach platform. Called the QiaReach Anti-SARS-CoV-2 Total, the test was launched in August following submission to the US Food and Drug Administration for Emergency Use Authorization. Jeff Boyle, global head of Qiagen's QuantiFeron franchise, which oversees the Ellume collaboration, said that the company planned to submit the antigen test, called the QiaReach SARS-CoV-2 antigen test, for EUA "in the coming days" and to launch it once it received authorization. Qiagen also plans to submit the test for a CE-IVD mark, though that will come after the US launch, he said.
Boyle said he believed the eHub and eStick system offered advantages over existing SARS-CoV-2 antigen tests, most notably a digital readout that removes the need for interpretation of results and also provides a convenient record of results as well as the ability to run up to eight tests per hub simultaneously. Turnaround time per test is 10 to 15 minutes.
Qiagen and Ellume originally developed the QiaReach platform for latent TB testing in resource-limited areas, which Boyle said could help it find a place in both small labs without molecular SARS-CoV-2 testing capabilities and at the point-of-care.
"What we're seeing from the pandemic is there is an expansion of laboratory services being offered in nontraditional settings," he said. "Nursing homes, schools, screening employees… airports and the like. We are seeing new emerging channels for testing."
Boyle said Qiagen does not see antigen test replacing molecular SARS-CoV-2 testing. Instead, it would serve as a more convenient first-line test in such settings like those he mentioned above, with perhaps molecular testing used to confirm the antigen results. In areas with evidence of large outbreaks, molecular tests could used to confirm negative antigen results.
He said the company plans to apply for EUA for testing first in symptomatic patients, followed by authorization for testing in the asymptomatic population.
Boyle said that in developing its QiaReach TB test Qiagen had evaluated a number of different assay technologies looking for one that would enable the performance of a traditional lab-based test in a more portable device and found that Ellume's immunoassay technology, which is based on quantum dot fluorescent nanoparticle, provided that level of performance.
Ellume is also using that technology for the two SARS-CoV-2 tests it is developing independent of Qiagen.
The point-of-care test will run on the company's Ellume-lab point-of-care platform, which consists of a digital reader and immunofluorescent test cartridges. Ellume plans to bring both a SARS-CoV-2 antigen test and a serology test to market in the US on that platform, which it will target to doctors offices and other CLIA-waived environments like pharmacies. Parsons said the company was completing clinical trials for the antigen test and planned to submit it for EUA shortly with a submission for the serology test to come after that. It will apply for EUA in the symptomatic population first and follow that up with a submission for using the test in the asymptomatic population, he said.
Ellume is developing a panel test for Flu A/B and RSV on the platform, as well, Parsons said.
The company is also working on an at-home SARS-CoV-2 antigen test. The test will use a lateral flow immunoassay format that can be read via smartphone.
Ellume has experience in the home infectious disease testing market, having partnered with GlaxoSmithKline to develop and commercialize a home test for flu. The partners last year completed a prospective study across 25 US sites on 996 subjects and found that the test detected flu A with 88 percent sensitivity and 98 percent specificity and flu B with 86 percent sensitivity and 98 percent specificity. They have submitted the test to FDA and hope to receive clearance "in the not too distant future," Parsons said.
Parsons added that the company's experience working with FDA on the home flu test has been useful in its home SARS-Cov-2 antigen test development process and noted that Ellume made its first pre-submission to the agency for the flu test in 2013.
"We have a pretty good understanding of [FDA's] concerns around self-testing for infectious disease," he said. "We've had pre-submission conversations with them around COVID, and they are really thinking about it the same way they have the home flu."
He said that the agency's experience with rapid antigen testing for flu, and particularly visually read flu tests, is likely informing its approach to rapid antigen testing for SARS-CoV-2. In 2017, the agency reclassified visually read rapid flu tests from Class I to Class II devices due to accuracy problems with these tests. The more stringent standard led to a number of poorer performing tests being withdrawn from the market, Parsons said.
"I think the agency doesn't want to find itself waiving through products that have uncertain performance and unproven usability and then to have to be in the position of having to peel those out," he said.
Parsons said that the challenges of producing a high-quality home test are "quite different" from the challenges of producing a high-quality point-of-care test. One of the most significant challenges, he noted, is usability.
Test developers need to demonstrate, for instance, that home users can consistently collect good samples, and that they won't injure themselves in the sampling process.
"There are all of the nuances around use of the test that are things the agency is going to be interested in," he said. "And the human factor studies that are required to prove those things are not insignificant challenges."
Parsons suggested that the company's work on its flu home test gives it a leg up in this regard.
"We have really worked those things through already," he said. "Our instructions have gone through 50 iterations over the years. The risk of misuse is very low with our product."
Parsons said Ellume is currently in clinical trials evaluating the test for both symptomatic and asymptomatic subjects and that it aims to submit data to the FDA by the end of the year and possibly sometime in November and to launch the test in the first half of 2021.
He said the company was in discussions with GSK around distribution of the SARS-CoV-2 home antigen test but that no decisions had been made as of yet.