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

CORONAVIRUS RESPONSE

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.

Everlywell says it will prioritize giving its at-home COVID-19 tests to healthcare professionals. Photo by Siri Stafford/Getty Images

Texas startup provides COVID-19 home-testing kits at no cost to medical professionals

now testing

The on-again, off-again launch of a coronavirus test from Austin startup Everlywell is on again — sort of.

On March 23, Everlywell was supposed to start shipping 30,000 test kits to U.S. consumers. But before a single test was sent, the U.S. Food and Drug Administration (FDA) blocked the distribution of at-home, self-administered tests from Everlywell and other companies.

Now, the Austin-based company is making the tests available primarily to hospitals and other healthcare providers in the U.S. to meet a "desperate need" for front-line medical professionals to be tested.

"In this evolving health crisis, our highest priority is to ensure that the people at highest risk get the accurate testing and care they need," Michelle Davey, CEO of Wheel Health, says in a March 23 release.

Everlywell says that effective March 23, its test is available only to hospitals and healthcare providers that offer it at no cost to their front-line workers, along with high-risk patients who exhibit coronavirus symptoms.

The company, which produces a variety of at-home lab tests, says its shift from testing of consumers to testing of healthcare workers and high-risk patients is "critically important" to help prevent the spread of what's known as the novel coronavirus. The virus causes the highly contagious and potentially deadly COVID-19 respiratory illness.

It's been a confusing few days since Everlywell announced it was making at-home tests for consumers. On March 20, the FDA said it hadn't authorized at-home, self-administered coronavirus tests from Everlywell or any other company. Three days later, on March 23, Dr. Deborah Birx, coronavirus coordinator for the White House, announced the federal government was clearing the way for self-swabbing coronavirus tests such as those made by Everlywell.

In a series of tweets March 23, Everlywell said it's working with the FDA on "a path forward" for at-home coronavirus tests of consumers.

"The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection," the federal agency says, "and we are actively working with test developers in this space."

Everlywell unveiled a $1 million program design to spur labs to speed up development of an at-home coronavirus diagnostic test. Many labs answered the call, allowing Everlywell to set up a coronavirus testing and diagnosis system in a matter of days. For consumers, each test will cost $135. Some providers of health savings accounts and flexible spending accounts will cover these tests.

Eventually, Everlywell wants to ship 250,000 tests per week.

At the same time, another Austin startup, Wheel Health, and Houston-based Microdrop have unveiled a partnership that will provide at-home coronavirus testing administered by licensed healthcare professionals, rather than consumers themselves, and supported by telemedicine technology. The federally approved product is geared toward people at high risk of the coronavirus or people with limited access to testing. For now, it's available only in Texas.

The test from Wheel, a telehealth provider, and Microdrop, a producer of at-home health tests, also costs $135. At the outset, the companies will roll out 5,000 test kits in Texas. After that, they plan to sell 10,000 test kits per week. Nationwide, the companies hope to offer 100,000 test kits per week by the end of April.

"Providing accurate medical guidance to people who are concerned about, or may have been exposed to, COVID-19 will determine the way this pandemic plays out in our country — and collaboration is essential to mobilizing toward this common goal rapidly and efficiently," says Dr. Rafid Fadul, chief medical officer of Wheel.

EverlyWell's online results will be available within 48 hours. EverlyWell/Facebook

Texas company first to launch at-home test for COVID-19

COVID-19 WATCH

As reports keep indicating a shortage of supply for COVID-19 tests around the country, a Texas startup has rolled out a new at-home test for consumers beginning today, March 23.

Everywell, which already offers an array of at-home lab tests, says 30,000 COVID-19 tests will be available in the initial batch. Free telehealth consultations will be provided for people who test positive for COVID-19, or the coronavirus.

As TIME first reported, this is the first U.S. company to offer at-home COVID-19 test kits directly to consumers.

"The extreme shortage of tests for COVID-19 puts millions of Americans at risk," Julia Cheek, founder and CEO of Everlywell, said in a March 18 release. "Everlywell is committed to helping stop the spread of COVID-19 in the U.S. by making this test widely available. As the national leader in at-home lab testing, we want to use our resources and expertise to help as many people as we can. We are committed to this fight, and we're here to help."

Working with a number of diagnostic labs, Everlywell plans to create testing and diagnosis capacity for 250,000 people per week.

Everlywell recently launched a $1 million program aimed at encouraging labs to fast-track development of an at-home COVID-19 diagnostic test. Many labs stepped up to the task, enabling Everlywell to create a COVID-19 testing and diagnosis infrastructure in a matter of days.

"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 says. "We have also reached out to government and public health officials to explore possibilities to provide it for free."

Each test costs $135, and is covered by participating providers of health savings accounts and flexible spending accounts.

The test can be requested online by consumers experiencing COVID-19 symptoms. Samples can be collected at home, preventing further exposure for consumers and the public. All of Everlywell's lab partners conducting COVID-19 tests comply with the U.S. Food and Drug Administration's emergency rules for COVID-19 testing.

"Given the high demand for testing, the company will work rapidly to make more tests available as the global supply shortage for COVID-19 diagnostic kits is addressed," the company says.

Like Everlywell's other tests, the COVID-19 test will be shipped to customers with everything needed to collect a test sample at home and safely send that sample to a certified lab. Samples will be shipped to labs overnight, secure online results will be available within 48 hours of the lab receiving a sample, and a free telehealth consultation with an independent board-certified physician will provided to anyone who tests positive.

Anyone seeking a test will be asked to fill out an online screening questionnaire.

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This article originally ran on CultureMap.

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West Coast innovation organization unveils new location in Houston suburb to boost Texas tech ecosystem

plugging in

Leading innovation platform Plug and Play announced the opening of its new flagship Houston-area location in Sugar Land, which is its fourth location in Texas.

Plug and Play has accelerated over 2,700 startups globally last year with corporate partners that include Dell Technologies, Daikin, Microsoft, LG Chem, Shell, and Mercedes. The company’s portfolio includes PayPal, Dropbox, LendingClub, and Course Hero, with 8 percent of the portfolio valued at over $100 million.

The deal, which facilitated by the Sugar Land Office of Economic Development and Tourism, will bring a new office for the organization to Sugar Land Town Square with leasing and hiring between December and January. The official launch is slated for the first quarter of 2025, and will feature 15 startups announced on Selection Day.

"By expanding to Sugar Land, we’re creating a space where startups can access resources, build partnerships, and scale rapidly,” VP Growth Strategy at Plug and Play Sherif Saadawi says in a news release. “This location will help fuel Texas' innovation ecosystem, providing entrepreneurs with the tools and networks they need to drive real-world impact and contribute to the state’s technological and economic growth."

Plug and Play plans to hire four full-time equivalent employees and accelerate two startup batches per year. The focus will be on “smart cities,” which include energy, health, transportation, and mobility sectors. One Sugar Land City representative will serve as a board member.

“We are excited to welcome Plug and Play to Sugar Land,” Mayor of Sugar Land Joe Zimmerma adds. “This investment will help us connect with corporate contacts and experts in startups and businesses that would take us many years to reach on our own. It allows us to create a presence, attract investments and jobs to the city, and hopefully become a base of operations for some of these high-growth companies.”

The organization originally entered the Houston market in 2019 and now has locations in Bryan/College Station, Frisco, and Cedar Park in Texas.

Uniquely Houston event to convene innovation experts across aerospace, energy, and medicine

guest column

Every year, Houston's legacy industries — energy, medicine, and aerospace — come together to share innovative ideas and collaborate on future opportunities.

For the eighteenth year in a row, the annual Pumps & Pipes event will showcase and explore convergence innovation and common technology themes across Houston’s three major industries. The hosting organization, also called Pumps & Pipes, was established in 2007 in Houston and is dedicated to fostering collaboration amongst the city's three major industries.

With NASA in its backyard, the world’s largest medical center, and a reputation as the “Energy Capital of the World,” Houston is uniquely positioned to lead in cross-industry convergence innovation and is reflected in the theme of this year’s event – Blueprint Houston: Converge and Innovate.

Here's what you can expect to explore at the event, which will take place this year on December 9 at TMC Helix Park. Tickets are available online.

The state of Texas’ aerospace investments

How are the recent strategic investments in aerospace by the State of Texas transforming the space economy and driving growth in adjacent industries? What is the case for cultivating a more dynamic and vibrant aerospace R&D environment?

These are the key questions explored in the opening session of Pumps & Pipes, moderated by David Alexander (Director, Rice Space Institute). Joining the discussion are distinguished leaders Norman Garza, Jr., Executive Director of the Texas Space Commission (TSC); as well as two members of the TSC board of directors: Sarah “Sassie” Duggelby, CEO/Co-Founder of Venus Aerospace; and Kathryn Lueders, GM at Starbase, SpaceX.

This panel will spotlight Texas’ critical role in shaping the future of aerospace, with a focus on its cross-sector impact, from space exploration to innovation in energy and health care. We’ll explore how the state’s investments are fueling research and development, creating economic opportunities, and fostering a more interconnected, high-tech ecosystem for the future.

Real-world applications of robotics and synthetic biology

Explore the groundbreaking intersection of syntheticbiology and robotics as they reshape industries from aerospace to energy to health care. Experts from academia and industry — Rob Ambrose of Texas A&M University, Shankar Nadarajah of ExxonMobil, Shalini Yadav of the Rice Synthetic Biology Institute, and Moji Karimi of Cemvita — will discuss the real-world applications and future possibilities of these two fields, including innovative uses of robotics and drones to monitor emissions from deep-sea oil rigs, and synthetic microbes that convert carbon dioxide into valuable chemical products.

Discover how synthetic biology and robotics are paving the way for a more sustainable, autonomous, efficient, and interconnected future.

The total artificial heart – a uniquely Houston story

Heart failure affects millions globally, yet only a small fraction of patients receive life-saving heart transplants. The Total Artificial Heart (TAH), developed by BiVACOR, offers a revolutionary solution for patients with severe heart failure who are ineligible for a transplant.

Luminary leader, Dr. Billy Cohn, will discuss the groundbreaking BiVACOR TAH, a device that fully replaces the function of the heart using a magnetically levitated rotary pump. This innovative approach is part of an FDA-approved first-in-human study, aiming to evaluate its use as a bridge-to-transplant for patients awaiting heart transplants.

Moderated by Dr. Alan Lumsden (Chair Dept. of CV Surgery at Houston Methodist Hospital), join Dr. Cohn as he shares insights, and the story-behind, this pioneering technology and its potential to reshape the future of heart failure treatment, offering new hope to thousands of patients in need.

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Stuart Corr is the director of Innovation Systems Engineering at Houston Methodist and executive director of Pumps & Pipes.

Houston schools shine on annual ranking of top institutions for 2025

best in class

Several Houston elementary and middle schools are at the top of the class when it comes to educating and preparing the next generation for a successful life and career, according to U.S. News & World Report's just-released list of 2025 Elementary and Middle Schools Rankings.

One such school – T.H. Rogers School in Houston ISD – is the No. 8 best middle school in Texas for 2025.

U.S. News ranked over 79,000 public schools on the state and district level using data from the U.S. Department of Education. Schools were analyzed based on their students' proficiencies in mathematics and reading/language arts on state assessments, and tie-breakers were decided based on student-teacher ratios.

Texas' best middle schools for 2025

Three Houston middle schools achieved spots among the top 10 best Texas middle schools for 2025, according to U.S. News.

T.H. Rogers School has a total enrollment of 1,063 students, with 87 percent of the student population scoring "at or above the proficient level" in mathematics, and 90 percent proficiency in reading. The school has a student-teacher ratio of 17:1, with 62 full-time teachers.

T.H. Rogers School also topped the district-wide list as the No. 1 best middle school in HISD.

Houston Gateway Academy - Coral Campus also ranked among the statewide top 10, coming in at No. 9 with a total enrollment of 914 students. U.S. News says 82 percent of HGA students are proficient in math, and 80 percent are proficient in reading.

"Houston Gateway Academy - Coral Campus did better in math and better in reading in this metric compared with students across the state," U.S. News said in the school's profile. "In Texas, 51 percent of students tested at or above the proficient level for reading, and 41 percent tested at or above that level for math."

Right behind HGA to round out the top 10 best Texas middle schools is Houston ISD's Briarmeadow Charter School. This middle school has 600 students, 69 percent of which are proficient in math and 74 percent are proficient reading.

Briarmeadow's student-teacher ratio is 16:1, which is better than the district-wide student-teacher ratio, and it employs 38 full-time teachers.

U.S. News also ranked Briarmeadow as the second best middle school in Houston ISD.

Six additional Houston-area schools ranked among the top 25 best middle schools in Texas, including:

  • No. 18 – Cornerstone Academy, Spring Branch ISD
  • No. 19 – Mandarin Immersion Magnet School, Houston ISD
  • No. 21 – Smith Middle School, Cypress-Fairbanks ISD
  • No. 22 – Seven Lakes Junior High, Katy ISD
  • No. 23 – Houston Gateway Academy
  • No. 25 – Beckendorff Junior High, Katy ISD

The best elementary schools in Texas

Jesus A. Kawas Elementary school in Laredo was crowned the No. 1 elementary school in Texas for 2025, while two Houston-area schools made it into the top 10.Tomball ISD's Creekside Forest Elementary in The Woodlands is the No. 7 best elementary school statewide, boasting 656 students, 42 full-time teachers, and one full-time counselor. Students at this school, which U.S. News designates is situated in a "fringe rural setting," scored 90 percent efficiency in math and 94 percent efficiency in reading.Following one spot behind Creekside Forest in the statewide ranking is Sugar Land's Commonwealth Elementary School in Fort Bend ISD, coming in at No. 8. Commonwealth has a student population of 954 with 55 full-time teachers, and two full-time counselors. The school's student-teacher ratio is 17:1, and 90 percent of students are proficient in math, and 94 percent in reading.U.S. News says student success at Commonwealth is significantly higher than the rest of Fort Bend ISD."In Fort Bend Independent School District, 59 percent of students tested at or above the proficient level for reading, and 47 percent tested at or above that level for math," U.S. News said in Commonwealth's profile. "Commonwealth Elementary [also] did better in math and better in reading in this metric compared with students across the state."Other Houston-area schools that were ranked among the 25 best in Texas are:
  • No. 13 – Bess Campbell Elementary, Sugar Land, Lamar CISD
  • No. 20 – West University Elementary, Houston ISD
  • No. 23 – T.H. Rogers School, Houston ISD
  • No. 25 – Griffin Elementary, Katy ISD

"The 2025 Best Elementary and Middle Schools rankings offer parents a way to evaluate how schools are providing a high-quality education and preparing students for future success," said LaMont Jones, Ed.D., the managing editor for Education at U.S. News. "The data empowers families and communities to advocate for their children’s education. Research continues to indicate that how students perform academically at these early grade levels is a big factor in their success in high school and beyond."

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This article originally ran on CultureMap.

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