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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Houston edtech company closes oversubscribed $3M seed round

fresh funding

Houston-based edtech company TrueLeap Inc. closed an oversubscribed seed round last month.

The $3.3 million round was led by Joe Swinbank Family Limited Partnership, a venture capital firm based in Houston. Gamper Ventures, another Houston firm, also participated with additional strategic partners.

TrueLeap reports that the funding will support the large-scale rollout of its "edge AI, integrated learning systems and last-mile broadband across underserved communities."

“The last mile is where most digital transformation efforts break down,” Sandip Bordoloi, CEO and president of TrueLeap, said in a news release. “TrueLeap was built to operate where bandwidth is limited, power is unreliable, and institutions need real systems—not pilots. This round allows us to scale infrastructure that actually works on the ground.”

True Leap works to address the digital divide in education through its AI-powered education, workforce systems and digital services that are designed for underserved and low-connectivity communities.

The company has created infrastructure in Africa, India and rural America. Just this week, it announced an agreement with the City of Kinshasa in the Democratic Republic of Congo to deploy a digital twin platform for its public education system that will allow provincial leaders to manage enrollment, staffing, infrastructure and performance with live data.

“What sets TrueLeap apart is their infrastructure mindset,” Joe Swinbank, General Partner at Joe Swinbank Family Limited Partnership, added in the news release. “They are building the physical and digital rails that allow entire ecosystems to function. The convergence of edge compute, connectivity, and services makes this a compelling global infrastructure opportunity.”

TrueLeap was founded by Bordoloi and Sunny Zhang and developed out of Born Global Ventures, a Houston venture studio focused on advancing immigrant-founded technology. It closed an oversubscribed pre-seed in 2024.

Texas space co. takes giant step toward lunar excavator deployment

Out of this world

Lunar exploration and development are currently hampered by the fact that the moon is largely devoid of necessary infrastructure, like spaceports. Such amenities need to be constructed remotely by autonomous vehicles, and making effective devices that can survive the harsh lunar surface long enough to complete construction projects is daunting.

Enter San Antonio-based Astroport Space Technologies. Founded in San Antonio in 2020, the company has become a major part of building plans beyond Earth, via its prototype excavator, and in early February, it completed an important field test of its new lunar excavator.

The new excavator is designed to function with California-based Astrolab's Flexible Logistics and Exploration (FLEX) rover, a highly modular vehicle that will perform a variety of functions on the surface of the moon.

In a recent demo, the Astroport prototype excavator successfully integrated with FLEX and proceeded to dig in a simulated lunar surface. The excavator collected an average of 207 lbs (94kg) of regolith (lunar surface dust) in just 3.5 minutes. It will need that speed to move the estimated 3,723 tons (3,378 tonnes) of regolith needed for a lunar spaceport.

After the successful test, both Astroport and Astrolab expressed confidence that the excavator was ready for deployment. "Leading with this successful excavator demo proves that our technology is no longer theoretical—it is operational," said Sam Ximenes, CEO of Astroport.

"This is the first of many implements in development that will turn Astrolab's FLEX rover into the 'Swiss Army Knife' of lunar construction. To meet the infrastructure needs of the emerging lunar economy, we must build the 'Port' before the 'Ship' arrives. By leveraging the FLEX platform, we are providing the Space Force, NASA, and commercial partners with a 'Shovel-Ready' construction capability to secure the lunar high ground."

"We are excited to provide the mobility backbone for Astroport's groundbreaking construction technology," said Jaret Matthews, CEO of Astrolab, in a release. "Astrolab is dedicated to establishing a viable lunar ecosystem. By combining our FLEX rover's versatility with Astroport's civil engineering expertise, we are delivering the essential capabilities required for a sustainable lunar economy."

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This article originally appeared on CultureMap.com.

Houston biotech co. raises $11M to advance ALS drug development

drug money

Houston-based clinical-stage biotechnology company Coya Therapeutics (NASDAQ: COYA) has raised $11.1 million in a private investment round.

India-based pharmaceuticals company Dr. Reddy’s Laboratories Inc. led the round with a $10 million investment, according to a news release. New York-based investment firm Greenlight Capital, Coya’s largest institutional shareholder, contributed $1.1 million.

The funding was raised through a definitive securities purchase agreement for the purchase and sale of more than 2.5 million shares of Coya's common stock in a private placement at $4.40 per share.

Coya reports that it plans to use the proceeds to scale up manufacturing of low-dose interleukin-2 (IL-2), which is a component of its COYA 302 and will support the commercial readiness of the drug. COYA 302 enhances anti-inflammatory T cell function and suppresses harmful immune activity for treatment of Amyotrophic Lateral Sclerosis (ALS), Frontotemporal Dementia (FTD), Parkinson’s disease and Alzheimer’s disease.

The company received FDA acceptance for its investigational new drug application for COYA 302 for treating ALS and FTD this summer. Its ALSTARS Phase 2 clinical trial for ALS treatment launched this fall in the U.S. and Canada and has begun enrolling and dosing patients. Coya CEO Arun Swaminathan said in a letter to investors that the company also plans to advance its clinical programs for the drug for FTD therapy in 2026.

Coya was founded in 2021. The company merged with Nicoya Health Inc. in 2020 and raised $10 million in its series A the same year. It closed its IPO in January 2023 for more than $15 million. Its therapeutics uses innovative work from Houston Methodist's Dr. Stanley H. Appel.