Brisbane-based diagnostics company Ellume has struck a major deal with the USA's Delta Airlines for its rapid COVID test, giving the Australian medtech access to up to one million passengers a month travelling with one of the world's largest airlines.
The deal, administered by Ellume's test verification and certification partner AZOVA, is seen as a major step forward for US citizens travelling to countries such as the United Kingdom which also accepts the company's tests for passenger arrivals.
This is the first agreement with a commercial airline reached by Ellume and paves the way for the company to ramp up production of its tests in a new US facility later this year.
"We're very pleased to be partnering with Delta to bring this testing to America and facilitating the opening up of borders for Americans to travel," says Ellume's CEO and founder Dr Sean Parsons, the 2020 Brisbane Young Entrepreneur of the Year and winner of the 2020 Australian Young Entrepreneur Award - Health & Medicine.
"For us, it's another commercialisation channel and another use case for our product."
Ellume's COVID test, which can identify a positive COVID case in minutes, is the only FDA-approved antigen test for asymptomatic cases that can be verified in just one test.
"All the other products for asymptomatic claims have to use two tests," says Parsons.
Under US Centers for Disease Control (CDC), any international passenger arriving in the use must be tested for COVID-19 before being allowed entry. That applies to US citizens returning home.
While Delta has not given Ellume estimates of the number of tests it will require, Parsons says the market is significant.
"Delta is one of the world's major airlines and they're seeing international travel volumes pick up rapidly post-pandemic, certainly through the summer months which is a heavy travel period into Europe," he says.
"They're talking volumes approaching a million passengers a month as typical but that has yet to be determined. While Delta hasn't given us specific volume predictions, certainly they are anticipating lots of travellers."
Ellume recommends travellers in the US acquire two tests for travelling, one before leaving the country and one upon arrival.
The tests are verified by AZOVA, Ellume's proctoring partner, which provides the certificate to the traveller for presentation to Delta Airlines as required by the CDC.
"Every country has its own approach in managing those risks depending on their own level of COVID," says Parsons.
"There are certainly many countries that are accepting our tests for inward travel. In the UK, for example, Americans can use our test in America and that is acceptable for entry into the UK."
Australia not in the race
Ellume is not having the same success in Australia, which Parsons doesn't see changing any time soon.
"In Australia, there is a legislative blocker on home testing for COVID tests right now. There will need to be a change in the legislation to allow for home testing. As a result, Ellume has not been engaged with the Therapeutic Goods Administration (TGA) to seek an authorisation because the TGA's hands are tied.
"If Federal Health Minister Greg Hunt would like to talk with us, we'd be very pleased to be of assistance. Certainly, at present, we wouldn't be able to sell the product in Australia."
Ellume's Australian production facility in Brisbane is currently delivering more than one million tests a month for global distribution. The company has capacity to lift this to four million units if needed.
Earlier this year, Ellume announced a US$231.8 million ($306 million) agreement to accelerate the US production of its COVID-19 home tests through a new facility, supported by the US Department of Defense and Department of Health and Human Services.
The US production facility, with capacity for 19.5 million tests a month, is expected to be completed in the fourth quarter of this calendar year.
Parsons says a US production base is aimed at not only helping the US respond to the pandemic but to prepare it for similar events in the future.
Parsons envisages continued demand for its rapid COVID tests "well into 2022" as countries look to manage their COVID risk.
"But the most important thing for us is the future of consumer testing for infectious diseases like COVID and influenza.
"There are medicines for flu and medicines for COVID on the way, and I think early diagnosis where you can connect with treatment is going to be the key to reducing transmissions and improving outcomes."Never miss a news update, subscribe here. Follow us on LinkedIn, Instagram and Twitter.
Business News Australia
Get our daily business news
Sign up to our free email news updates.