The emergence of potentially vaccine-resistant Covid-19 variants and rising case numbers have obscured what seemed like a path out of the pandemic. As testing for the virus continues to be a major part of daily life, Brisbane, Australia-based Ellume is expanding to meet demand.

In May, the digital diagnostics firm announced it would establish its first US-based Covid-19 home test kit manufacturing facility in Frederick, Maryland. The plant will begin limited production in the second half of 2021, and once scaled up to full operations, will have the capacity to produce 19 million Covid-19 home tests per month. 

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Dan Mallon, Ellume’s vice president for business development, tells fDi that the company is focused on developing home diagnostics tests in the US, with the aim of becoming a major player, boosting global health and future pandemic preparedness.

“We’re investing in both Australia and the US currently, but we’re really excited to see that growth take off beyond that,” he says. Ellume is in active discussions with other countries and is looking across North America, Europe and parts of Asia.

“Most countries would like to have onshoring production capabilities,” says Mr Mallon, adding that new production sites will take more time as the company gets its new capacity up and running.

Ellume is hiring for 1500 positions in Frederick, with several hundred needed in the next few months. Mr Mallon says that between 10% and 20% will be technical skilled labour, with a much larger share made up of people working on the manual lines and kit packing, eventually moving the facility towards an automated production line.

US government support

Back in February, Ellume signed an agreement worth $231.8m with the US government to accelerate the production of its Covid-19 home test kit. Ellume’s app-based nasal swab tests, which have an analyser connected via Bluetooth to a smartphone, provide a result in 15 minutes and are 96% as effective as PCR tests sent to a laboratory.

“We’re creating a new category of digital diagnostics for consumer use that has not really existed for infectious diseases,” asserts Mr Mallon. When the pandemic hit, Ellume had already been working on a flu diagnostic with UK pharma giant GlaxoSmithKline and was in early discussions with the US Food and Drug Administration (FDA).

This helped the company design the first rapid self-test to be granted emergency use authorisation by the FDA for both symptomatic and asymptomatic use without a prescription.

“The US government saw alignment with Ellume’s goals to be a strong pandemic partner with an objective to move into the US market,” adds Mr Mallon. As part of their agreement, Ellume will supply 8.5 million Covid-19 home tests to the US government by the end of the year.

Currently, all Ellume test kits are produced on a smaller scale out of its Australian facility, which Mr Mallon says is also supported by the US government, but has faced some supply chain issues, like many other companies during the pandemic.

Future of Covid-19

While Mr Mallon stresses he cannot predict the future, Ellume is confident its novel diagnostics will be crucial to fighting Covid-19 and other infectious diseases.

“I think we will see this pandemic move into more of an epidemic situation, where we see Covid-19 having flare-ups and outbreaks annually,” he says, predicting steady demand for testing, similar to the flu and strep.

“We’re planning for our technology to be used annually and likely be incorporated in a panel of testing when respiratory illnesses pop up in different communities,” he concludes.

This article first appeared in the August/September print edition of fDi Intelligence. View a digital edition of the magazine here.