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.

------

This article originally ran on CultureMap.

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.

------

This article originally ran on CultureMap.

Ad Placement 300x100
Ad Placement 300x600

CultureMap Emails are Awesome

Property Showcase

Amazon to expand Prime Air drone delivery to almost 500 U.S. cities

In the air

https://sanantonio.culturemap.com/news/city-life/prime-air-expands-service-texas/By the end of the year, more Texans may be able to get ultrafast deliveries through Amazon’s Prime Air drone delivery service. On Wednesday, August 19, the company announced plans to majorly expand drone delivery to nearly 500 cities in the U.S., a sixfold increase from its current footprint.

Although Amazon did not reveal the cities it is targeting for the expansion, it almost certainly will include Texas. The state, which ranks among the biggest states for ecommerce activity, is currently home to four of the nation’s 11 Prime Air sites, including the Houston suburb of Richmond, as well as San Antonio, Waco, and Richardson (near Dallas).

For drone deliveries, the company tends to target areas unencumbered by skyscrapers and major airports. Each facility covers a delivery area of approximately 175 square miles.

Prime Air deliveries must be five pounds or less and fit into a large shoebox. Still, Amazon says more than 60 percent of its most ordered items are eligible. The list includes groceries, cosmetics, medications, clothing, and small electronics like Apple AirPods and Ring doorbells. More fragile items — like eggs — are not available through the service.

Orders arrive as quickly as 30 minutes, with most packages dropped around 60 minutes after checkout. Prime members will enjoy free delivery on orders $50 or more and a $2.99 fee for orders under $50. Non-members pay $4.99.

Amazon drone delivery Photo courtesy of Amazon

According to Amazon, customers should have little worries about orders being damaged or drones being entangled in trees. Shoppers see and confirm their delivery point when placing their first drone delivery order and can select a new area at any time.

Amazon also sends a notification to customers if there is no safe delivery space and does not fly at night or under severe weather conditions. The retail giant says noise is minimal with sound levels similar to idling delivery trucks.

Georgia, Ohio, Illinois, Idaho, and New York are the first states on the expansion plan. All future sites will be subject to regulatory hurdles like zoning changes, but the company is confident it will be serving tens of millions of new customers by year-end.

---

This article originally appeared on CultureMap.com.

Telsa targets Houston area for new $10 billion manufacturing plant

Project Sun City

Electric vehicle and clean energy company Tesla is considering building a new $10.1 billion solar cell manufacturing facility in Fort Bend County, according to documents filed with the Texas Comptroller’s Office.

If approved, the plant, called Project Sun City, would be located on a 3,050-acre site off FM 762 and FM 1994 in Richmond, Texas. Tesla aims to finish construction in 2028, with the plant being operational by early 2029.

The plant will manufacture photovoltaic (PV) solar cells and modules that can convert sunlight into electricity. PV Magazine reports that the facility is "the largest single manufacturing investment Tesla has proposed on paper."

Advisory and consulting firm Kroll submitted the documents to the Texas Comptroller of Public Accounts and noted if an agreement regarding tax incentives isn't reached, the project will exit Texas.

Tesla has requested credits under the Jobs, Energy, Technology, and Innovation (JETI) Act. The incentive program aims to attract large, capital-intensive economic development projects by lowering the property taxes an entity must pay over 10 years if it meets requirements related to job creation and investment. For example, pharmaceutical giant Bristol Myers Squibb Co. recently announced that its forthcoming $2.3 billion Houston-area manufacturing site is a qualified project under the JETI program.

Kroll predicts that the facility would create 9,712 new full-time jobs, over 1,100 construction jobs and billions of dollars in future property tax revenue, the documents show. Additionally, it says the project will spur $1.1 billion in local business expenditures and that Texas would increase its GDP by approximately $107 billion as a result of the project activities.

Tesla opened its $200 million Megafactory in Brookshire, Texas, last year. The company is continuing its goal to deploy 100 gigawatts of solar manufacturing in the U.S before the end of 2028. According to the U.S. Energy Information Administration, 100 gigawatts is equal to about 8 percent of the country's power grid capacity.

---

This article originally appeared on EnergyCapitalHTX.com.

Tech giant Apple opens Advanced Manufacturing Center at massive Houston facility

up and running

Cupertino, California-based Apple Inc. unveiled its Advanced Manufacturing Center in the Houston area last week, marking the completion of the second of three facilities the tech giant plans to launch in the city by the end of this year.

The 20,000-square-foot training center will welcome small- and medium-sized businesses for free training and educational sessions to "help accelerate smart manufacturing across America," according to a release from Apple. Apple opened a similar Apple Manufacturing Academy in Detroit last year.

The AMC is part of Apple's 500,000-square-foot site in northwest Harris County. It also features a massive manufacturing site for Apple’s advanced AI servers and Mac mini. The facility was originally slated to open in 2026, but Apple began producing its advanced AI servers ahead of schedule in 2025.

The company said it plans to begin manufacturing its Mac mini at the site this year. The move will bring production of the compact desktop computer to the U.S. for the first time.

“In less than nine months, we have invested hundreds of millions of dollars into this Houston facility. We stood up a factory, started production, and shipped the first advanced AI servers off the line. Today, we’re thrilled to open our new Advanced Manufacturing Center, a place where businesses, workers, and students can learn the same innovative processes that we use to make Apple’s most groundbreaking products. And we’re pleased to begin Mac mini production later this year,” Tim Cook, Apple’s CEO, said in the news release. “We believe in American workers and American ingenuity, and we are moving at an incredible pace because we want to build more than great products. We want to build the future of American manufacturing.”

Apple's Advanced Manufacturing Center. Photos courtesy Apple

Apple's Houston expansion is part of a $600 billion commitment the company made to the U.S. in 2025.

The company originally announced plans in February 2025 to open a 250,000-square-foot Houston factory, but doubled the facility's planned size about a year later. Apple has reported that the factory will employ thousands of workers.

“Houston is grateful to Apple for this significant investment in our city. The Advanced Manufacturing Center will create local jobs and will continue improving the quality of life of Houston residents," Houston Mayor John Whitmire added in the release. "The AMC also recognizes our city as a growing technology hub and solidifies Houston’s leadership in the manufacturing sector of the United States.”

The opening comes on the heels of New Jersey-based pharmaceutical giant Bristol Myers Squibb Co. officially naming Houston home of its new $2.3 billion, state-of-the-art manufacturing site. Read more here.

View All Listings