Ellume’s rapid COVID-19 tests in FDA’s fast lane

America is set to benefit from Australian COVID technology, with the Morrison government lukewarm on the idea.

Dr Sean Parsons in the Ellume lab in East Brisbane, with their new testing technology. Picture: Lyndon Mechielsen

More than 100,000 rapid COVID-19 tests are rolling off the production line at Brisbane-based biotech Ellume, with the company set to receive imminent approval from the US Food and Drug Administration to deploy the tests across the world’s biggest economy.

Ellume has applied for emergency use authorisation from the FDA, with the regulatory body indicating its support before a formal decision expected next week.

It comes as the number of coronavirus cases continues to rise in the US, with the number of people being admitted to hospital at record levels, painting a grim picture for the holiday season.

The US government has already injected $US30m ($40.4m) into Ellume to accelerate the production of the tests, which can detect COVID-19 within 15 minutes — a move that’s hoped to return the world to some kind of normality, allowing more passenger planes back in the air, employees in the office and crowds at stadiums and concerts.

But Australia will have to wait to receive the homegrown rapid tests, with Ellume continuing to receive only “cursory engagement” and “limited interest” from the Morrison government, according to chief executive Sean Parsons.

He said the company expected to begin its first shipments into the US next January and would be focused on serving the American market for at least the next six months.

Dr Parsons — a critical care doctor who specialised in emergency and intensive care medicine — said clinical trials had revealed the at-home tests were on par with current laboratory tests, achieving 94 per cent sensitivity for detecting COVID-19, and 96 per cent for identifying negative cases.

“The FDA is in a rapid review program right now and we are hopeful of a clearance in coming days. We ran our study in accordance with the FDA guidelines, collecting the data that they required to be able to approve it,” Dr Parsons said.

“There isn’t an at-home COVID-19 test approved yet for non-prescription use, so it is a world-first in that regard.

Cumulative confirmed Covid-19 cases - source is John Hopkins University

“Compared to other point-of-care tests, we compare favourably, so it is equivalent or better performance and definitely better than the ones here in Australia.  “In terms of comparison to the laboratory tests, which are the ones that get sent off to a pathology group, it’s pretty close. The comparator for our study is a lab test, so if you take 100 per cent for the lab test, that’s what we are comparing to.”

Dr Parsons said the clinical trial data was for both symptomatic and more importantly ­asymptomatic cases, which can become superspreaders because they are unaware they have the virus, making testing more important.

“Asymptomatic people are the ones who you might use the test for screening,” he said.

The tests uses an analyser connected to a smartphone via Bluetooth which digitally analyses a self-collected sample from the user’s nasal passage. Results are transmitted through a secure cloud connection, generating a digital certificate of the results.

Dr Parsons said manufacturing was “well under way”, with the first production batches to be completed before Christmas. He said the company was adding about 50 people a week to its 250-person workforce, meaning it was on track to double its team by January.

Current manufacturing has all been manual, with Ellume set to implement an automated production line, which Bosch is manufacturing, by February. Once installed, it will increase Ellume’s production capacity to almost 300,000 units a day.

Asked how Ellume’s engagement with Australian regulators and governments was going, Dr Parsons said the Queensland government had been more receptive but it was yet to gain traction with the federal government.

The federal government has spent $1.2m on consultants, including Ernst & Young and McKinsey and Company, to advise on the rollout of COVID-19 vaccines, with one contract equating to $26,000 a day for a month.

“There has certainly been more engagement with the Queensland government who have been more interested through the election cycle but also after the election in what we are doing,” Dr Parsons said. “They understand that we are making products that could be useful in Australia. They are certainly much more receptive and we hope that they would be able to help us to get to scale sooner, make more product and employ more people.

“But we still have only had cursory engagement with the federal government, I will say, who have been generally of limited interest.”