Austin-based medical diagnostics company Everlywell says it will begin offering a home testing kit for COVID-19 early next week to help close the shortage of testing methods during the coronavirus outbreak.
The company said 30,000 of the tests will be available starting Monday. The tests allow users to collect swab samples at home, which can then be submitted to a government-certified laboratory for testing, the company said.
Those who use the test will be able to receive their results through a telemedicine visit within about two days, according to the company. The tests are compliant with the U.S. Food and Drug Administration’s Emergency Use Authorization, the company said.
The company said the tests will only be offered in the U.S. for now. Everlywell says it is working with multiple labs to increase capacity to offer a larger number of tests on a regular basis.
“We plan to eventually have testing and diagnosis capacity for a quarter of a million people weekly. However, this process will take several weeks and could take a few months,” the company said in a written statement.
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The FDA announced last month that it would consider emergency use authorization for proposals involving diagnostic devices for the coronavirus. A similar policy was adopted in 2016 in relation to the Zika virus, according to the agency’s website.
Everlywell CEO Julia Cheek spoke with the American-Statesman last week after the company announced that it was putting up a $1 million incentive to fuel development of home testing kits that could help people avoid medical facilities.
Cheek said the company’s ability to respond to the outbreak has been an affirmation of its goal of providing affordable, convenient access to lab testing.
“Our team has been working around the clock with top scientists and laboratories in the nation to develop a test that we will make available at the lowest price possible while covering our costs, at no profit to the company,” Cheek said in a written statement.
Potential users should go to Everlywell’s website and complete a screening questionnaire, which the company said is based on guidelines provided by the U.S. Centers for Disease Control and Prevention.
“The test will be available for $135 at no profit to Everlywell, and will be covered by participating HSA and FSA providers,” the company said in a news release.
Cheek said her goal is to find a way to offer the test at no cost, and said the company has been communicating with federal government officials for potential solutions.
“Given the momentum in Congress about providing free coronavirus testing for Americans, we want to do everything we can to make this test free,” Cheek said.
Tom Kowalski, president of the Texas Healthcare and Bioscience Institute, recently spoke to the Texas House Public Health Committee at a hearing on Texas’ preparedness to respond to the virus.
He said Everlywell’s development of the test is an example of how the state’s biotech and life sciences industry can contribute to fighting COVID-19.
“We expect to see more and more results from the industry, hopefully, in terms of vaccines and research capabilities, in the months to come,” he said.