US signs deal for at-home virus tests

The White House said Monday that it has signed a $230 million contract with an Australian company to produce an over-the-counter coronavirus test that can be taken at home without a prescription and that yields immediate results.

The contract will allow the company Ellume, which manufacturers the test, to quickly increase its production and create a manufacturing plant in the US, said Andy Slavitt, the White House COVID-19 senior adviser, during a White House briefing on Monday.

"Ellume has been ramping up manufacturing and will ship 100,000 test kits per month to the US from February through July" he said. "That's good but it's obviously not where we'll need to be."

The contract provides money for Ellume to build a manufacturing plant in the US for the at-home tests. Slavitt said that could scale up production to more than 19 million test kits per month by the end of the year, 8.5 million of which are guaranteed to the US government, he said.

Slavitt said the test can detect the coronavirus with 95 percent accuracy within roughly 15 minutes. The price of the test is about $30, but Slavitt said that "costs will come down, only when we can get to that mass production and scale".

"There's a chicken-and-egg problem, which we have taken a step to solve today," he said during the briefing.

The test requires a smartphone, the company has said. The test is authorized to be used by people both with and without symptoms. It can also be used on children as young as 2 years old.

Ellume's test was the first over-the-counter, rapid coronavirus home test to be authorized by the Food and Drug Administration (FDA). It was approved Dec 15. But the test was expected to be available only in limited quantities.

The FDA has cleared three coronavirus tests that can be processed entirely at home, but Ellume's is the only one that doesn't require a prescription. None of the three tests are widely available.

Public health authorities have been seeking rapid, easy-to-use tests for the coronavirus that can be performed anywhere, to enable people to quickly determine whether they have the virus and to allow for wider screening.

Ellume shipped out its first batch of 10,000 tests to the US the week of Jan 18, the company said last week. Ellume had originally aimed to ship 100,000 tests a day starting in January.

The company is looking in Maryland, Virginia, California and other states for a location for its first US production facility, according to a company spokeswoman.

To use the test, a person uses a nasal swab and inserts their sample into the test kit, which searches for pieces of virus proteins, called antigens.

The results are then transmitted to the person's phone via Bluetooth, where the person can choose to share the results with a health-care provider. The result can't be accessed without downloading the app, the company says.

The mobile application requires users to input their ZIP codes and dates of birth. Names and email addresses are optional. The information is sent to public health authorities.

The announcement of the test comes as the US death toll has climbed past 440,000 with more than 95,000 lives lost in January, the deadliest month yet of the coronavirus in the US, according to data from Johns Hopkins University.

There was some good news in the data. Deaths are running at about 3,150 per day on average, down slightly by about 200 from their peak in mid-January, and cases are trending downward in all 50 states.

Dr Philip Landrigan, an epidemiologist at Boston College, told The Associated Press that vaccines are a factor in the sharp drop in cases but are not the primary cause. Instead, he said, the crisis has become increasingly "depoliticized" in recent weeks as more people come to grips with the threat and how they can help slow the spread of the virus.

Also at the White House briefing on Monday, Dr Rochelle Walensky, the director of the Centers for Disease Control and Prevention (CDC), said that US has increased its ability to detect new, more contagious coronavirus variants tenfold.

She said that labs were aiming to sequence 7,000 samples of the virus per week, a significant increase from the week of Jan 10, when she said that only 251 samples had been sequenced. Last week, 2,238 samples were sequenced for the virus mutations, she said.

Jeffrey Zients, the White House's COVID-19 response coordinator, said last week that the nation's sequencing effort was "totally unacceptable".

Agencies contributed to this story.