How Ellume Health’s COVID-19 Test Broke into the US Market

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16 February 2021

Pictured: MTPConnect's Director Communications Caroline Duell speaking to Ellume Health's Founder and CEO Dr Sean Parsons in the virtual podcast studio.

In a recent podcast episode, we spoke to Founder and CEO Dr Sean Parsons from Brisbane-based Ellume Health for the full story behind developing the first COVID-19 Home Test to receive US Food and Drug Administration Emergency Use Authorisation.

Ellume has signed a $US300 million (AU$385 million) million deal with the US Government to supply the over-the-counter diagnostic which uses smart-device connectivity -- and ramping-up Australian manufacturing will be critical to meeting demand.

With funding support from the Queensland Government, Ellume is scaling-up production capacity at its Richlands laboratory to manufacture more than 200,000 testing kits a day. And with the installation of new, state-of-the-art automated production lines, the company’s 300-plus staff will be able to produce 10 million tests a month for export.

It’s been a ten-year journey and Sean shares his thoughts on commercialisation success and how to boost sovereign capabilities to grow medical products manufacturing in Australia.

“Our story starts in the swine flu pandemic in 2009/2010, where I was working as an emergency doctor in Queensland and was really on the front lines through the response,” Sean recalled.

“The question really arose to me at the time ‘if we could enable a way to diagnose people with swine flu earlier, and if we could put that at the hands of consumers themselves as well as doctors, we would be able to get an early and accurate diagnosis of the flu and that would enable people to socially isolate and take medicines more early and reduce the transmission of people in the community’.

“So, the Ellume story began well before COVID-19, a decade ago to focus on common infectious diseases that cause pandemics.”

Sean shares his team’s experience of tackling the US market.

“Ellume has been very focused on the US market since its inception, we are based in Australia and love Australia, and we hope our products can come here at scale in the future, but our perspective is that our products need to be successful in America first and having been successful there, we will be able to achieve the scale and the commercialisation to be able to take the product elsewhere in the world,” Sean added.

“We have been engaging with the US FDA for many years around consumer diagnostics for infectious diseases, the FDA have been very forceful and very reasonable about what’s required to navigate a pathway for these products to be approved and so when COVID came around we really had a running start at engaging with the agency and proving to them that our product was safe and effective.

“As we now move into the commercialisation phase, we have an attitude of partnering where those partnerships can enable us to achieve scale more quickly, and to get the product out to more people so we have a big partnership with GlaxoSmithKline and we are in detailed discussions around the Home COVID product, both are through those consumer channels and employers or institutions and other important places where our product can be of benefit.

“So, the commercialisation [process] is a different kind of challenge to the technology development and it is equally important, but it also comes on the back of technical success and successful regulatory engagement and it is something that we’re very much in the thick of right now, as we look to scale our production and commercialise the product in the US.”

Sean shared some of his inspiration for other start-ups and entrepreneurs in the MTP sector.

“We have had some good fortune in terms of terrific investors that have supported us through the hard times where the technology wasn’t working and a lot of people that believed in the cause of the company that we were doing something great,” Sean concluded.

“Without that support from those people and their willingness to believe in us, me and in the team there’s no doubt that we wouldn’t have survived those difficult days.

“My only advice would be that persistence and perseverance are important characteristics to bring, and it sort of seems like Ellume has popped up and become this ‘overnight success’, but there has been a decade of hard work that led to that and I think that’s the same for all medtech and healthcare success stories.

“We have terrific people now that do all of that really important work in the background and the team is obviously very important, and there is a saying in entrepreneur land that ‘your company is defined by its first five employees’, and that’s the case for us – with the exception of one, they’re all still with us.  

To find out more about Ellume’s diagnostic and how they broke into the US market, listen in to the full interview here.