CORONAVIRUS RESPONSE

Texas startup’s at-home COVID-19 test finally approved by feds

The at-home COVID-19 tests are now available. EverlyWell/Facebook

After its earlier effort was tripped up, Austin-based startup Everlywell on May 16 finally gained approval from the U.S. Food and Drug Administration to launch its at-home coronavirus test.

In a May 18 release, Everlywell says the self-administered test will be available later this month. The company, which specializes in at-home tests for an array of conditions, is the first to receive approval from the FDA for an at-home coronavirus test that's not associated with a lab or a manufacturer of diagnostic products.

The FDA's emergency authorization allows Everlywell to work with a number of certified labs that process authorized tests, rather than just a single lab.

"The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, says in a release.

Everlywell's at­-home test determines the presence or absence of the novel coronavirus, which causes COVID­-19 illness. Everlywell's test kit uses a short nasal swab and includes:

  • A digital screening questionnaire reviewed by a healthcare provider.
  • Instructions on how to ship the test sample to a lab.
  • Digital results within 48 hours of the sample being received by the lab.
  • Results reviewed by an independent physician.

Anyone who tests positive test will receive a telehealth consultation. All positive test results are reported to federal and local public health agencies when mandated.

On March 23, Everlywell was supposed to start shipping 30,000 coronavirus test kits to U.S. consumers. But before a single test was sent, the FDA blocked distribution of at-home, self-administered tests from Everlywell and other companies. After that, Everlywell pivoted to supplying coronavirus tests to health care providers and organizations.

As with the company's previously approved coronavirus test, Everlywell says its test for individuals is sold at no profit. The $109 price covers costs such as overnight shipping to a lab, lab-processing fees, and kit components. Some health insurers cover coronavirus tests.

Everlywell says it's working with members of Congress to enable companies that are neither healthcare providers nor labs to be directly reimbursed by health insurers. The startup also is exploring how its coronavirus test could be made available for free.

"Widespread access to convenient testing will play a crucial role in the country's ability to address the pandemic and prevent overburdening our healthcare facilities. As the national leader in connecting people with high­-quality laboratory testing, we are committed to fighting the spread of this virus in America," Julia Cheek, founder and CEO of Everlywell, says in the Everlywell release.

The company continues to supply its coronavirus tests to qualified healthcare organizations and government agencies.

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This article originally ran on CultureMap.

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Building Houston

 
 

New study shows Houston has minority-owned startups than any other Texas city. Photo by Tim Leviston/Getty Images

Both Houston and the state of Texas earned high rankings on a recent study by Self Financial that looked at the percentage of minority-owned startups in regions across the U.S.

"Today there are nearly 170 thousand minority-owned startups in the U.S., employing over 700 thousand people and generating close to $100 billion in annual revenue," the report said. "Based on demographic trends, these numbers are likely to grow as the population continues to diversify on racial and ethnic lines."

According to the report, about 30 percent of startups in Greater Houston are minority-owned. This is the fifth highest percentage in the country. There are nearly 5,600 minority-owned startups in the MSA, employing more than 22,700 people and bringing in more than $3.1 billion annually, the report found.

The Bayou City outranked New York but just a tenth of a percentage. But neighboring San Antonio edged out the Bayou City for the No. 4 spot, with roughly 31 percent of startups being minority-owned.

The top three cities on the list were all in California. The San Jose-Sunnyvale-Santa Clara metro had the highest percentage of minority-owned start ups. Roughly 46 percentage of startups there are minority-owned. The Los Angeles area and San Bernardino area followed in the second and third spots, respectively.

Dallas was the only other Texas metro to make the cut. According to the study, roughly 24 percent of startups there are minority-owned, earning it a No. 9 spot on the list.

The state earned a No. 4 spot on a similar ranking. According to that report, nearly 27 percent of startups in Texas are minority-owned and are responsible for employing more than 87,000 individuals and turn out roughly $11.5 billion in sales annually.

Still, Self Financial argues that minorities are underrepresented in the startup economy in cities, states, and throughout the U.S.

"Non-Hispanic whites, who represent around 60 percent of the U.S. population, own nearly 80 percent of the nation's startup businesses," the report says.

In Houston, nearly 64 percent of the population is considered a minority. And yet, those individuals only represent about 30 percent of startup ownership. Even in top-ranked San Jose the gap is wide. The population in the metro has a 68 percent minority share, and only 46 percent of startups are minority-owned.

St. Louis had the narrowest margin among large, high-rated metros. Minorities represent about 26 percent of the population there, and 25 percent go startups in the city are minority-owned.

In Texas minorities represent about 59 percent of the population, but only 27 percent of startup ownership. Nationwide minorities represent about 40 percent of the population but own about 20 percent of startups, according to the study..

Nationally minorities are most represented in the start-up economy in the accommodation, food services, and retail sectors. And the report adds that the demographic has faced exceptional challenges in 2020—from a business perspective, the largest roadblock was (and is often) access to capital.

"Minority households have lower pre-existing levels of wealth and savings to put towards a new business, while banks and other creditors are less likely to approve loans for Black or Hispanic small-business owners than they are for white business owners," the report says. "Without upfront capital to invest in a growing business, minority entrepreneurs struggle to run and scale their operations.

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