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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10+ can't-miss virtual business and innovation events in Houston for June

where to be online

Despite much of the state returning to some state of normalcy, larger groups are still not encouraged to gather quite yet in order to avoid an uptick in COVID-19 cases.

With that in mind, here are over 10 Houston innovation events you can attend virtually via online meetings. Be sure to register in advance, as most will send an access link ahead of the events.

June 2 — How Fashion Brands Optimize E-Commerce and Sustainability During a Pandemic

Kim Roxie, founder of LAMIK Beauty, moderates a panel of e-commerce startup founders for The Ion to discuss modern issues the female founders are facing.

Details: The event is at 5:30 p.m. on Tuesday, June 2. Learn more.

June 4 — Startup Growth After COVID-19 with Sputnik ATX

Curious about what business and startup growth may look like post-COVID-19? Join Sputnik ATX Partner Joe Merrill via General Assembly for a discussion on how to grow a business and raise a round during a pandemic.

Details: The event is at 3 p.m. on Thursday, June 4. Learn more.

June 6 — Enventure Basecamp: Business Building Workshop

Our community-driven business building basecamp series returns this June to support a local innovator construct their healthcare venture.

Details: The event is at 9 a.m. on Saturday, June 6. Learn more.

June 9 — Pulse Check-Today's Funding Landscape

Today's current crisis has changed the mindset of many industry strategic partners, investors and overall stakeholders. From pivoting investment priorities, to identifying new areas of innovation, the investor landscape is constantly shifting.

For small to medium sized biotechs, it can be hard to keep up with promised milestones while also planning and anticipating the future of their companies. How could companies be preparing for not only the short-term but for years to come? What should be prioritized in the coming months? Who is still investing? How can they find the right partners for them as they move forward?

Details: The event is at 11 a.m. on Tuesday, June 9. Learn more.

June 9 — VC Ask Me Anything Virtual Event featuring The Artemis Fund

These livestreams, which will include audience Q&A, will tackle the big questions on everyone's mind, like how founders should adjust in the face of the pandemic and what fundraising will look like once the pandemic loosens its grip. Click here to stream.

Details: The event is at 2 to 3 p.m. on Tuesday, June 9. Learn more.

June 11 — Energy and Utilities: Drones, Connectivity, and Operations of the Future

Preparing for the future can be confusing. How can you keep up with industry and regulatory advancements, or know when to invest in new technology? That's why we teamed up with Southern Company to share how they're preparing — and how you can, too. Join Skyward and Southern Company for a discussion about energy and utility operations of the future and practical steps you can take now to prepare your enterprise.

Details: The event is at 1 p.m. on Thursday, June 11. Learn more.

June 11 — Venture vs The Virus: Texas Halo Fund IV

The Houston Angel Network presents Episode 3 of Venture vs The Virus. During this virtual event you will hear from the managing directors of the Texas Halo Fund on the launch of their new fund and the investment opportunities they are seeing as a result of the health crisis.

Details: The event is at 2 p.m. on Thursday, June 11. Learn more.

June 11 — Intro to Fundraising in FemTech & AMA with Juliana Garaizar and Dr. Barreto

Are you raising capital for your FemTech startup? Join us VIRTUALLY for an overview from venture capitalists and investors at Intro to Fundraising in FemTech & Ask Me Anything!

Details: The event is at 2 p.m. on Thursday, June 11. Learn more.

June 16 — Women in Tech Summit presented by Accenture

Capital Factory will host a virtual Women In Tech Summit dedicated to increasing diversity in the entrepreneurial and tech community while making its coworking space an inclusive environment for all.

Attendees can look forward to a special keynote guest, insightful fireside chats, discussion sessions, a startup showcase, Epic Office Hours, and panels on relevant topics facing the tech ecosystem.

Details: The event is at noon to 5 p.m. on Tuesday, June 16. Learn more.

June 17-19 — Virtual Rice Business Plan Competition

This year's Rice Business Plan Competition, which was planned for March 26 to 28, was canceled due to COVID-19, but the Rice Alliance for Technology and Entrepreneurship has decided to offer up an alternative: A virtual RBPC. Forty two student teams will compete over three virtual events.

Details: The event is from June 17 to 19. Learn more.

June 23 — Virtual Fireside Chat: Fredrik Tukk, Maersk Drilling

Join The Ion for a chat with Fredrik Tukk-Head of Innovation Scouting at Maersk Drilling about how organizations can benefit from innovation

Details: The event is at 3 p.m. on Tuesday, June 23. Learn more.

June 24 — The Ion Startup Demo Day

Top tier mentors, local investors, and personalized pitch feedback for participating startups -- nothing's changed but the address. Whether you're a serial entrepreneur or just looking to get involved in the community, this event is for YOU.

Details: The event is at 6 p.m. on Wednesday, June 24. Learn more.

June 30 — TMC Accelerator for Cancer Therapeutics Info Session

The TMC ACT team will answer questions including who should apply to TMC ACT, what are the timelines, and what value to expect.

Details: The event is at 3 p.m. on Tuesday, June 30. Learn more.

Houston earns mediocre grade in ranking of best metros for college grads

WELCOME TO THE UNREAL WORLD

This year's college graduates are entering a real world that's more unreal than any we've seen in our lifetimes. And they're facing a world with uncertain prospects.

Against that jarring backdrop, the Apartment List website developed a ranking of the top U.S. metro areas for college graduates, and Houston sits in the middle of the pack. The Bayou City ranks 26th among the country's 50 largest metro areas.

The ranking, published May 13, takes into account six data points:

  • Average wages among recent college graduates
  • March 2020 unemployment rate
  • Rental costs for recent college graduates
  • Share of adult population with a college degree
  • Share of recent college graduates working in remote-friendly occupations
  • Share of workforce in high-risk industries

Houston fares well in terms of average wages among recent college graduates ($46,681) and college graduates working in remote-friendly occupations (73 percent), but doesn't fare as well for the share of adults with a college degree (31 percent) and the share of full-time workers in high-risk industries (13 percent).

Austin appears at No. 6 on the list, with Dallas-Fort Worth at 21 and San Antonio at No. 43. Apartment List says Austin's economic scores "are well-rounded across the board," but the metro area stands out for its high share of college-educated adults (43 percent) and high share of college graduates working in remote-friendly occupations (77 percent).

"Each of the nation's five largest metropolitan areas — New York, Los Angeles, Chicago, Dallas, and Houston — failed to break the Top 10," Apartment List notes. "The Class of 2020 is better off looking into smaller regions that strike a healthier balance between affordability and economic opportunity."

San Jose, California, the epicenter of Silicon Valley, tops the ranking, followed by San Francisco; Washington, D.C.; Boston; and Milwaukee.

Ranked last is Las Vegas, preceded by Riverside-San Bernardino, California; New Orleans; Miami; and Orlando, Florida.

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This article originally ran on CultureMap.

3 Houston innovators to know this week

who's who

This week's Houston innovators to know are all using technology — but in completely different ways and across various sectors.

From creating a circular and sustainable economy for your company's technology to an online platform for your child's various activities — and even a socially distant way of checking temperatures — here is this week's who's who of Houston innovation.

Tudor Palaghita, CEO and founder of Camppedia

Tudor Palaghita has advanced his startup, Camppedia, so that parents can have virtual and in-person activities for their kids this summer. Photo courtesy of Camppedia

Like most of the world, Tudor Palaghita's year isn't going as planned. The founder of Camppedia — an online marketplace and tool for parents finding and managing their kids' activities — was hoping this summer was going to be his company's break-out moment and proof of concept. Instead, he's had to act quickly and pivot to focus on community and virtual opportunities.

"If anything, the pandemic forced us to move a lot of things forward," Palaghita says on the recent episode of the Houston Innovators Podcast. "The focus on the community was also something coming earlier than planned, but it was the most wonderful thing to come out of this. It really feels like everybody came together to give and to help each other."

Camppedia's business model is to give local camp and program providers — mostly small businesses, Palaghita says — a place to seamlessly reach parents. Now, these providers need Camppedia's platform more than ever as parents seek options a as they return to work or continue to look for at-home entertainment for their kids. Click here to read more.

Robert Kester, founder of Rebellion Photonics and president and general manager at Honeywell

Robert Kester found a new use for his temperature monitoring tech he created for the oil and gas industry. Photo courtesy of Honeywell

As the pandemic began to spread across the country, Robert Kester saw an opportunity for his technology he built for the oil and gas industry. Kester founded Rebellion Photonics, which Honeywell acquired in December of last year, and the company's ThermoRebellion temperature software uses infrared imaging technology and artificial intelligence to quickly conduct non-invasive screenings of people before they enter offices, banks, airports, as businesses begin to reopen.

"The key component is our software powered by artificial intelligence," Kester tells InnovationMap. "Our imaging systems leverage a decade of experience in the most advanced imaging technologies for gas leak detection, fire detection, and intrusion monitoring applications. The system features uncooled high-resolution FPA infrared sensors allowing for each pixel to be assessed for temperature."

By Kester's and his team's estimates, the ThermoRebllion system will be ready to deploy as early as June. Click here to read more.

Ed Wooten, director of IT asset disposition at Smith

Building a circular economy for electronics requires attention to detail in the areas of design, buyback, or return systems, advanced recycling and recapturing, durability and repair, and urban mining, writes Ed Wooten. Photo courtesy of Smith

For 20 years, Ed Wooten has worked to help clients figure out how to navigate the processes of buyback, recycling, and repair in order to create sustainable and profitable solutions to reduce e-waste.

"The world produces 40 million tons of e-waste annually, and only 20 percent of that is being disposed of properly," Wooten writes in a guest column for InnovationMap. "A circular economy is a system in which all materials and components are kept at their highest value and where e-waste is essentially designed out of the system."

Wooten gives his advice for creating a circular economy. Click here to read more.

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