- On Friday, the Food and Drug Administration granted emergency approval to a new COVID-19 diagnostic test.
- The test, made by Roche, can be used on its automated machines, which hundreds of labs have. The machines can provide results in three hours, a much shorter time frame than existing testing that’s done manually or semi-automatically.
- The US is struggling to ramp up testing for the new coronavirus, with centres around the US running only a limited number of samples per day.
- That will start to change as tests like Roche’s come online, and as others look to make tests that can be shipped to homes or done rapidly in the doctor’s office.
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The US has been struggling to get more testing for the novel coronavirus online in the wake of the pandemic.
The tests patients are getting often take days to come back, leaving patients with suspected cases in limbo. On top of that, the US is facing shortages of key materials used to run the tests.
In response, organisations have been looking at ways to ramp up testing capacity, cut down on the time needed to run the tests, and find alternative ways to deliver the tests. The giant life-sciences firm Roche just launched a new tool that can be run more quickly, while lab testing firms are speedily developing their own capability to run tests for the coronavirus. Startups are jumping in, too.
Getting a test online
In February, the FDA issued a new policy meant to speed up the ability for labs to get approval for tests for the coronavirus, which causes COVID-19, up and running. Under it, labs can begin testing once they have filed for emergency use, rather than waiting for official approval, during which time the labs have to validate the test is giving accurate results.
It speeds up a process that can often take two months, Everlywell CEO Julia Cheek told Business Insider. The Austin-based startup sells at-home diagnostic tests including for sexually transmitted diseases, fertility, and food sensitivity. The company has worked with labs to bring new tests to the platform.
“We’ve underinvested in the whole clinical infrastructure in the US for some time now,” Cheek said.
Cheek said she’s aiming to offer at-home testing for the coronavirus within the next week or two.
More broadly, the FDA’s new policy has helped centres around the US bring testing online, though most only have the capacity to run a limited number of samples per day.
On Friday, the FDA granted emergency clearance to a new COVID-19 diagnostic test.
The test, made by healthcare giant Roche, can be used on its automated machines, which hundreds of labs have. The machines can provide results in three hours, a much shorter time frame than existing testing that’s done manually or semi-automatically. Depending on the machines being used, thousands of samples could be process a day.
National clinical laboratory companies LabCorp and Quest Diagnostic have started bringing tests online, broadening access.
Moving test to the home
As the novel coronavirus spreads around the US, health systems have been calling for more patients to seek care virtually, rather than coming into the office. But for now, testing has to be done in the office.
To help, Everlywell on March 8 put out a call to labs offering $US1 million in funding to help them send their emergency use forms into the FDA and get COVID-19 testing up and running. So far, Cheek said, the company’s working with five labs.
Everlywell connect patients with doctors who can order the test. Everlywell send the kits out, patients can get the kits and then ship them to the closest lab Everlywell works with. Cheek said she’s expecting the process to take about four days from collection to results, and hopes it can be faster.
Everlywell typically doesn’t take insurance for its tests. But in this case, it’s had interest from insurers to cover a potential COVID-19 at-home test, Cheek said. It’s aiming to keep the cost low, and Cheek said the company is not going to make money off of the test.
Some of the labs Everlywell is working with have quoted Everlywell a price of $US200 per test, she said.
The potential for a rapid test
In some parts of the world, researchers are developing more rapid testing, similar to the tests we have for strains of influenza A and B.
More rapid testing could be key to even further mitigating the coronavirus outbreak, as well as take pressure off the supply of flu tests, which are at risk of facing shortage as they’re used as the first test before patients receive a COVID-19 test.
WATCH: How the coronavirus is tested in this private New York lab amid testing shortages
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- Read more:
- One chart shows how many coronavirus tests per capita have been completed in 8 countries. The US is woefully behind.
- The US is struggling to test more people for the coronavirus. Now it’s facing a shortage of the materials used to run those tests.
- Delays and errors have put the US far behind other countries in testing and treating coronavirus patients: ‘We are trotting along while they’re racing’
- An Italian doctor at the epicentre of the coronavirus response shares his best advice for the US to avoid being overwhelmed by the pandemic
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