Aus biotech company supplies at-home COVID-19 tests to US

Queensland-based digital diagnostics company Ellume has announced a US$231.8 million (AU$302.7 million) agreement with the US Department of Defense (DOD), in coordination with the Department of Health and Human Services (HHS), to accelerate domestic US production of its COVID-19 home tests.

The Ellume COVID-19 Home Test includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyser for use with an app on the user’s smartphone. The app provides step-by-step video instructions on how to perform the test, including a self-collected mid-turbinate swab. The sample is analysed and results are automatically transmitted to the user’s smartphone in 15 min or less.

The product is the first rapid self-test for COVID-19 detection authorised by the US Food and Drug Administration (FDA) for both asymptomatic and symptomatic use without a prescription, having demonstrated 96% accuracy — with an overall sensitivity of 95% and specificity of 97% — when compared to an emergency-use-authorised RT-PCR laboratory test. With the Centers for Disease Control and Prevention reporting that at least 50% of COVID-19 cases are transmitted asymptomatically, the test will play a crucial role as the only diagnostic tool authorised for non-prescription use as a screening tool in the United States.

“Our focus is enabling the US to minimise community transmission and reopen as quickly as possible,” said Ellume founder and CEO Dr Sean Parsons. “The Ellume COVID-19 Home Test is the only authorised test of its kind and is an essential tool for the broader pandemic response in the US.”

“We are prioritising our partnership with the US Government to mobilise tests quickly and in the most impactful way. We will fulfil the order for these tests at the same time as we ramp up the output across our production facilities, creating more possibilities for retail and private institution use in the future.”

The agreement includes funding to support the establishment of Ellume’s US-based manufacturing facility and the delivery of 8.5 million COVID-19 home tests that will be distributed across the US in accordance with the National Strategy for the COVID-19 Response and Pandemic Preparedness plan. This US-based manufacturing capacity builds upon Ellume’s existing Australian production capacity, which is on track to procure approximately 200,000 tests per day this quarter.

Under the agreement, Ellume will be delivering 100,000 tests per month from its current manufacturing facility in the Brisbane suburb of Richlands until the US facility is built. At full capacity, the Richlands and US facilities will be capable of producing up to 10 million and 19 million tests per month, respectively.

Queensland Deputy Premier and Minister for State Development, Infrastructure, Local Government and Planning Steven Miles recently confirmed that the Queensland Government is providing funding to Ellume from the Essential Goods and Supply Chain program, which will allow the company to increase manufacturing of its suite of rapid testing kits at the Richlands facility. Dr Parsons said the funding will also enable the installation of state-of-the-art automated production lines to assemble the rapid COVID-19 tests for export.

“The funds from the state government will greatly assist in upscaling manufacturing to meet the growing demand for Ellume’s products, providing greater supply security,” Dr Parsons said.

“This is world-leading and life-saving diagnostic testing technology, created and manufactured right here in Queensland.”

The company has plans to expand availability of its tests into Europe later this year, subject to securing the required approvals.

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