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 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.

------

This article originally ran on CultureMap.

Ad Placement 300x100
Ad Placement 300x600

CultureMap Emails are Awesome

Houston suburb ranks as No. 3 best place to retire in Texas

Rankings & Reports

Texas retirees on the hunt for the right place to settle down and enjoy their blissful retirement years will find their haven in the Houston suburb of Pasadena, which just ranked as the third-best city to retire statewide.

A new study conducted by the research team at RetirementLiving.com, "The Best Cities to Retire in Texas," compared the affordability, safety, livability, and healthcare access for seniors across 31 Texas cities with at least 90,000 residents.

Wichita Falls, about 140 miles northwest of Dallas, claimed the top spot as the No. 1 best place to retire in Texas.

The senior living experts said Pasadena has the best healthcare access for seniors in the entire state, and it ranked as the No. 8 most affordable city on the list.

"Taking care of one’s health can be stressful for seniors," the report said. "Harris County, where [Pasadena is] located, has 281.1 primary care physicians per 1,000 seniors — that’s almost 50-fold the statewide ratio of 5.9 per 1,000."

Pasadena ranked 10th overall for its livability, and ranked 25th for safety, the report added.

Meanwhile, Houston proper ranked as the No. 31 best place to retire in Texas, but its livability score was the 7th best statewide.

Seven of the Lone Star State's top 10 best retirement locales are located in the Dallas-Fort Worth Metroplex: Carrollton (No. 2), Plano (No. 4), Garland (No. 5), Richardson (No. 6), Arlington (No. 7), Grand Prairie (No. 8), and Irving (No. 9). McAllen, a South Texas border town, rounded out the top 10.

RetirementLiving said Carrollton has one of the lowest property and violent crime rates per capita in Texas, and it ranked as the No. 5 safest city on the list. About 17 percent of the city's population is aged 65 or older, which is higher than the statewide average of just 14 percent.

The top 10 best place to retire in Texas in 2026 are:

  • No. 1 – Wichita Falls
  • No. 2 – Carrollton
  • No. 3 – Pasadena
  • No. 4 – Plano
  • No. 5 – Garland
  • No. 6 – Richardson
  • No. 7 – Arlington
  • No. 8 – Grand Prairie
  • No. 9 – Irving
  • No. 10 – McAllen
---

This article originally appeared on CultureMap.com.

Rice University lands $18M to revolutionize lymphatic disease detection

fresh funding

An arm of the U.S. Department of Health and Human Services has awarded $18 million to scientists at Rice University for research that has the potential to revolutionize how lymphatic diseases are detected and help increase survivability.

The lymphatic system is the network of vessels all over the body that help eliminate waste, absorb fat and maintain fluid balance. Diseases in this system are often difficult to detect early due to the small size of the vessels and the invasiveness of biopsy testing. Though survival rates of lymph disease have skyrocketed in the United States over the last five years, it still claims around 200,000 people in the country annually.

Early detection of complex lymphatic anomalies (CLAs) and lymphedema is essential in increasing successful treatment rates. That’s where Rice University’s SynthX Center, directed by Han Xiao and Lei Li, an assistant professor of electrical and computer engineering, comes in.

Aided by researchers from Texas Children’s Hospital, Baylor College of Medicine, the University of Texas at Dallas and the University of Texas Southwestern Medical Center, the center is pioneering two technologies: the Visual Imaging System for Tracing and Analyzing Lymphatics with Photoacoustics (VISTA-LYMPH) and Digital Plasmonic Nanobubble Detection for Protein (DIAMOND-P).

Simply put, VISTA-LYMPH uses photoacoustic tomography (PAT), a combination of light and sound, to more accurately map the tiny vessels of the lymphatic system. The process is more effective than diagnostic tools that use only light or sound, independent of one another. The research award is through the Advanced Research Projects Agency for Health (ARPA-H) Lymphatic Imaging, Genomics and pHenotyping Technologies (LIGHT) program, part of the U.S. HHS, which saw the potential of VISTA-LYMPH in animal tests that produced finely detailed diagnostic maps.

“Thanks to ARPA-H’s award, we will build the most advanced PAT system to image the body’s lymphatic network with unprecedented resolution and speed, enabling earlier and more accurate diagnosis,” Li said in a news release.

Meanwhile, DIAMOND-P could replace the older, less exact immunoassay. It uses laser-heated vapors of plasmonic nanoparticles to detect viruses without having to separate or amplify, and at room temperature, greatly simplifying the process. This is an important part of greater diagnosis because even with VISTA-LYMPH’s greater imaging accuracy, many lymphatic diseases still do not appear. Detecting biological markers is still necessary.

According to Rice, the efforts will help address lymphatic disorders, including Gorham-Stout disease, kaposiform lymphangiomatosis and generalized lymphatic anomaly. They also could help manage conditions associated with lymphatic dysfunction, including cancer metastasis, cardiovascular disease and neurodegeneration.

“By validating VISTA-LYMPH and DIAMOND-P in both preclinical and clinical settings, the team aims to establish a comprehensive diagnostic pipeline for lymphatic diseases and potentially beyond,” Xiao added in the release.

The ARPA-H award funds the project for up to five years.

Houston doctor wins NIH grant to test virtual reality for ICU delirium

Virtual healing

Think of it like a reverse version of The Matrix. A person wakes up in a hospital bed and gets plugged into a virtual reality game world in order to heal.

While it may sound far-fetched, Dr. Hina Faisal, a Houston Methodist critical care specialist in the Department of Surgery, was recently awarded a $242,000 grant from the National Institute of Health to test the effects of VR games on patients coming out of major surgery in the intensive care unit (ICU).

The five-year study will focus on older patients using mental stimulation techniques to reduce incidences of delirium. The award comes courtesy of the National Institute on Aging K76 Paul B. Beeson Emerging Leaders Career Development Award in Aging.

“As the population of older adults continues to grow, the need for effective, scalable interventions to prevent postoperative complications like delirium is more important than ever,” Faisal said in a news release.

ICU delirium is a serious condition that can lead to major complications and even death. Roughly 87 percent of patients who undergo major surgery involving intubation will experience some form of delirium coming out of anesthesia. Causes can range from infection to drug reactions. While many cases are mild, prolonged ICU delirium may prevent a patient from following medical advice or even cause them to hurt themselves.

Using VR games to treat delirium is a rapidly emerging and exciting branch of medicine. Studies show that VR games can help promote mental activity, memory and cognitive function. However, the full benefits are currently unknown as studies have been hampered by small patient populations.

Faisal believes that half of all ICU delirium cases are preventable through VR treatment. Currently, a general lack of knowledge and resources has been holding back the advancement of the treatment.

Hopefully, the work of Faisal in one of the busiest medical cities in the world can alleviate that problem as she spends the next half-decade plugging patients into games to aid in their healing.