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Ellume finds U.S. manufacturing facility as part of $232M contract for at-home Covid tests

Ellume received a $232 million contract to manufacture more of its over-the-counter home Covid-19 tests in the U.S.  Photo credit: Ellume

After it won a $232 million contract to manufacture more of its over-the-counter Covid-19 tests in the U.S., Ellume is preparing to open a local facility.

The Brisbane, Australia-based flu diagnostics company will lease space in two buildings currently under construction in Frederick, Maryland. It plans to begin limited production around the third quarter of 2021, and to be fully operational by the end of the year.

As part of its contract with the Department of Defense and the Department of Health and Human Services, Ellume plans to deliver 8.5 million tests to the U.S. government before the end of the year. When the facility is fully operational, it should be able to produce a total of 19 million tests per month, the company said.

“This new facility will help to ensure our Covid-19 home tests are mobilized quickly at scale and also establishes an ongoing domestic source of diagnostics for potential future outbreaks,” Ellume CEO Dr. Sean Parsons said in a news release.

The company has its roots in another pandemic — Parsons started Ellume shortly after the swine flu pandemic in 2009. As an emergency physician, he was frustrated by the slow turnaround time for laboratory tests and few available rapid influenza tests that were also accurate.

The company started by developing a rapid at-home flu test, and has since branched out to other infectious diseases. Beyond Covid-19, Ellume said it plans to use the new manufacturing facility to quickly respond to future large-scale outbreaks and pandemics.

To lead its U.S. business, it poached a former QIAGEN executive, Jeff Boyle, who most recently served as the diagnostics giant’s global head of franchise for  QuantiFERON. Ellume worked closely with Qiagen on the tuberculosis test as well as a separate Covid-19 antigen test.

At the end of the year, the Food and Drug Administration gave Ellume an emergency use authorization to offer its rapid antigen test over-the-counter. Users swab their nose, and put the results into a Bluetooth-connected analyzer, which sends results to their smartphones in about 20 minutes.

Currently, Ellume is selling the test at a handful of CVS stores, but plans to make it available more broadly across the U.S. by late May.

That said, at its current price of about $40, the test won’t likely work as a routine screening tool. At that price, it could work for occasional uses, such as testing before travel, but would be too costly for daily testing or for most families, experts said.