Designing rapid, accurate and digital diagnostic tests for infectious diseases
CEO: Sean Parsons
Based: Brisbane, Australia
The scoop: To go back to workplaces or enter public venues these days, people are often required to show they’re COVID-19-negative and have to constantly renew their status with the latest results. The growing demand for coronavirus tests has put a stress on central labs, calling for alternative diagnostic methods.
Enter Ellume. The Australian firm has developed the first at-home COVID-19 test that can be sold over the counter in the U.S. without a doctor’s prescription. It was funded by the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative, which is aimed at speeding up the development and manufacturing of COVID tests.
What makes Ellume Fierce: Before Ellume’s COVID home test, there were other tests that allow patients to take a sample at home and mail to central labs for analysis. But people have to wait days for the results. The FDA has also authorized Abbott’s BinaxNOW and a kit from Lucira for rapid COVID tests at home, but people need a prescription to get them.
By contrast, consumers can buy Ellume’s test off the shelf. Once the device takes a valid sample, it can yield a result in about 15 minutes. And it’s accurate, too. In a simulated clinical study, the test showed a positive result agreement of 96% with more complex standard-of-care RT-PCR test and a negative rate agreement of 100% in symptomatic people. The rates were 91% and 96%, respectively, in asymptomatic individuals.
At its core, the test uses a fluorescent immunoassay platform, which captures small fluorescence signals using quantum-dot-based fluorescent nanoparticles. In COVID’s case, the technology is leveraged to detect SARS-CoV-2 nucleocapsid antigen.
Ellume stood out and convinced the FDA of an over-the-counter authorization by offering three features, company founder and CEO Sean Parsons explained in a recent interview.
First, on top of the core coronavirus detector, the test boasts a unique sampling control, which can detect an insufficient sample. It’s the only rapid immunoassay test that has that control, Parsons said.
Ellume’s test works in tandem with a smartphone app that offers step-by-step instructions on how to perform the test and displays the result when completed. Because it’s fully digitally connected, the data can be automatically sent to health authorities, offering an additional means for tracking the disease.
“The third thing to note is that we have a lot of confidence that people can use our tests correctly, and we generated that confidence in developing our home flu test,” Parsons said.
If it weren’t for COVID, the company would be rolling a similar at-home influenza test at the moment, on which it has partnered with GlaxoSmithKline’s consumer health department. To prepare for the approval and launch of that diagnostic kit, the company has conducted years of studies proving that people can follow the instructions and use the test correctly step by step, Parsons said.
“Those are the three really big things: the sampling controls, the digital connectivity and the data capture, and the depth of the human factors confidence,” he said.
Besides the consumer-facing tests, Ellume has partnered with Qiagen on portable digital COVID antibody and antigen tests for healthcare professionals. Those tests combine Ellume’s core technology with Qiagen’s QuantiFERON platform, which can allow one examiner to perform eight easy tests simultaneously. The pair originally formed the collaboration to target tuberculosis to help regions with less sophisticated laboratory networks and it quickly pivoted to COVID once the need arose.
Parsons founded Ellume in 2010, fresh off the H1N1 swine flu pandemic and after a stint at a busy emergency department. “It occurred to me that the best way to respond to this pandemic would be to put diagnostics in the hands of doctors in the community, in the hands of family practitioners and pediatricians—but even further to create a home flu test that could enable people to diagnose themselves,” he recalled. “If we could move that diagnosis earlier in the treatment pathway, then we could reduce the spread within the community.”
Ten years in the making, Ellume previously floated a potential IPO for last year, but even though its business is “in a good position” to go public, Ellume’s focus right now is scaling its manufacturing with the aim to produce well over 100 million COVID home tests this year, Parsons said.
That effort recently got backing from a $231.8 million contract by the U.S. Department of Defense, which will help boost the company’s U.S. domestic production capacity to 640,000 tests per day.
Moving forward, “expanding the menu is a key piece for us,” Parsons said. The company will be looking to release its flu products, and flu-RSV and flu-COVID combination tests in the near future, and expand into other diseases.