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GLOBALOUTLOOK DEVELOPMENTSITES


Theultimate test T


heemergence of potentially vaccine- resistant Covid-19 variants and rising casenumbers have obscured what


seemed like a path out of the pandemic. As testing for the virus continues to be amajor part of daily life, Brisbane, Australia-based Ellume is expanding tomeet 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 permonth. Dan Mallon, Ellume’s vice president for


business development, tells fDi that the com- pany is focused on developinghome diagnos- tics tests in the US, with the aimof 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 onshor-


ing production capabilities,” saysMr Mallon, adding that new production sites will take more time as the company gets its new capac- ity up and running. Ellume is hiring for 1500 positions in


Frederick, with several hundred needed in the next fewmonths. Mr Mallon says that between 10%and 20% will be technical skilled labour, with amuch larger sharemade up of people working on the manual lines and kit packing, eventuallymoving the facility towards an auto- mated production line.


USgovernmentsupport Back in February, Ellume signed an agreement worth $231.8mwith 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


16 Smart thinking: Ellume’s app-based tests connect via bluetooth to a smartphone


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 sawalignment with


Ellume’s goals to be a strong pandemic partner with an objective tomove into the USmarket,” 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, likemany other companies dur- ing the pandemic.


Future ofCovid-19 While Mr Mallon stresses he cannot predict the future, Ellume is confident its novel diag- nostics will be crucial to fighting Covid-19 and other infectious diseases. “I think we will see this pandemicmove


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.■


www.fDiIntelligence.com August/September 2021


ELLUMECOVID-19 HOMETEST KIT PLANT


Location Frederick, Maryland, US


Full production capacity 19 million home tests per month


Headcount 1500


PROJECTPROFILE


DIGITAL DIAGNOSTICS COMPANY ELLUME IS BUILDING A COVID-19 HOME TEST KIT FACILITY IN MARYLAND. ALEX IRWIN-HUNT REPORTS


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