The Biden administration said it had reached a $ 230 million deal with Australian diagnostics firm Ellume USA LLC to produce an over-the-counter, home-based Covid-19 test.
Previous Food and Drug Administration certify the test. So far, the FDA has removed three Covid-19 tests that can be processed entirely at home, but Ellume is the only test that does not require a prescription. None are currently widely available.
The company is expected to produce 19 million tests a month by the end of the year, Andy Slavitt, senior adviser to the White House’s Covid-19 response team, said Monday. Under the agreement, 8.5 million tests will be guaranteed to the US government.
For months, public health authorities have been calling for a quick and easy-to-use test for Covid-19 that can be done anywhere, both to allow people to quickly determine whether they have Covid-19 or not and to allow for broader screening. Home tests are expected to be less precise than those performed in a laboratory and will likely require further testing in certain situations.
Ellume shipped the first batch of 10,000 tests to the US in the week of January 18, the company said last week. Ellume originally aimed to deliver 100,000 tests a day starting in January.
“We are working hard with our supply chain partners to find the materials needed to achieve our goals, but we share the same global challenges other leaders face in terms of raw material shortages,” a company spokesman said Monday.
Ellume has now increased its manufacturing capacity in Australia to 100,000 tests per day and is on track to produce 200,000 tests daily during the quarter, the spokesman said.
The company is looking in Maryland, Virginia, California and other states for the location of its first US production facility, a spokesman said earlier.
The Ellume test is estimated to cost around $ 30 and requires a smartphone, the company said. This test is approved for use by people with and without symptoms. It can also be used in children as young as 2 years.
Mr Slavitt said Monday’s government announcement was a step towards mass production and lowering prices. “There is a chicken and egg problem, which we have resolved today,” he said at a briefing.
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Company received before $ 30 million from federal authorities as part of a Diagnostic Rapid Acceleration initiative run through the National Institutes of Health.
To run tests, someone takes a nasal swab and puts the sample into the analyzer. The test looks for bits of viral protein, called antigens.
The test results are then sent to the person’s phone via Bluetooth, where the person can choose to share the results with a healthcare provider. The results cannot be accessed without downloading the app, the company said.
The mobile application requires users to enter their ZIP Code and date of birth. Name and email address are optional. The information is sent to public health authorities.
Write to Tarini Parti on [email protected] and Brianna Abbott at [email protected]
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