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'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 Intercontinental Airport's innovative upgrades ready for takeoff

coming soon

After almost five years of construction, passengers heading out of Bush Intercontinental Airport on October 22 will be the very first to experience the expanded, upgraded, and stylish Terminal D-West Pier, an expansion of the existing Terminal D.

The new terminal is part of a broader initiative, the IAH Terminal Redevelopment Program (ITRP), a $1.458 billion project aimed at modernizing the airport's international travel capabilities. ITRP is the single largest capital improvement project developed by Houston Airports and include the refresh of the existing Terminal D, completed in 2023; the expansion of Terminal D with a new D-West Pier, which will be completed this fall 2024; and a new International Central Processor, slated for winter of 2024 and summer of 2025. More than 3,000 people spent more than one million hours on the construction project.

Terminal D-West Pier features six new gates — D1 through D6 — that can simultaneously accommodate wide-body aircraft or converted to accommodate 10 narrow-body airplanes. The expanded terminal with its new capabilities supports increasing demand from passengers and airlines and should enhance the overall travel experience.

The new terminal is part of a broader initiative, the IAH Terminal Redevelopment Program (ITRP), a $1.458 billion project aimed at modernizing the airport's international travel capabilities. Photo courtesy of Houston Airports

In addition to adding 160,000-square-feet, the new wing also boasts eight new, Houston-inspired works by local artists. Those kind of details are why the Houston airport system won Best Airport Art & Entertainment Program in the prestigious Skytrax awards.

The airport's 250 newly-hired employees will work among 16 new retail and dining concessions concepts in the Terminal D-West Pier. Passengers can dine at Houston Supply Co., which opened last month. Local restaurants The Kitchen and The Annie, along with popular national brands Popeyes, Einstein Bros. Bagels, Jamba Juice, Be Relax, Jetero Market, Semi-Sweet Confectionary, and a Lego Store will open for business on October 22.

The new wing also boasts eight new, Houston-inspired works by local artists. Photo courtesy of Houston Airports

"We are focused on improving the overall passenger experience at the airport — from parking and traffic to providing modern terminals with the right amenities. This project is a major investment in our city's future," Houston Mayor John Whitmire said in a statement. "The newly expanded international terminal enhances Houston's reputation as a world-class city and provides a boost to our economy, supporting jobs and attracting more visitors from around the globe."

The new terminal offers a host of other amenities designed to make passengers' experiences more comfortable. They include a mother's room, a sensory room, a child's play area, and expanded men's, women's, and family restrooms. The restrooms utilize smart technology sensors that trigger soap and water. Door locks alert to whether a restroom stall is vacant or occupied and soft LED lighting accentuates floor-to-ceiling photography spotlighting Houston's natural beauty.

The new wing has 16 new retail and dining concessions concepts. Photo courtesy of Houston Airports

An International Arrivals corridor provides views of the airfield, the concourse, and large-scale photography inspired by Houston.

More than 500 modern and comfortable seats, including chairs, cushioned benches, and cozy loungers, featuring cup holders and charging capabilities, are present inside the terminal.

"We are excited to share this milestone with the residents of Houston," said Jim Szczesniak, director of aviation for Houston Airports. "The opening of the Terminal D-West Pier is a testament to the hard work and dedication of our team and our partners. This world-class facility will provide a seamless and efficient travel experience for millions of passengers each year. The new pier will provide the necessary capacity so that Houston can continue to attract more nonstop flights to cities around the globe."

New features include a mother's room, a sensory room, a child's play area, and expanded men's, women's, and family restrooms. Photo courtesy of Houston Airports

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This article originally ran on CultureMap.

12 health tech startups named to Houston accelerator's next bootcamp

onboarding

Twelve promising health tech startups have been selected for the annual bootcamp at the Texas Medical Center.

TMC's Accelerator for HealthTech selected 12 companies from around the world and across specialties for the opportunity. Following the bootcamp, TMC will move forward a selection of startups to join its accelerator.

"Houston, a thriving hub for innovation, is rapidly becoming the destination of choice for healthtech companies," reads a statement from TMC. "With the Texas Medical Center at its heart, the city offers unparalleled resources, cutting-edge research facilities, and a collaborative spirit that fosters growth. This environment not only attracts startups but also provides them with the necessary tools to navigate the complex landscape of healthcare commercialization."

Through the bootcamp, the participants will engage with advisors and industry experts, refine their business models, prepare for market entry, and have opportunities for collaboration with the TMC's member organizations.

The selected bootcamp companies, according to TMC, include:

  • Alyf, founded in Newport Beach, California, has developed a personalized cardiac care system that brings patients and providers together with real-time, AI-driven insights, enabling them to monitor, track, and improve cardiac health outcomes collaboratively.
  • Seoul, South Korea-based Deepmetrics leverages artificial intelligence to provide ICU smart care services that optimize medical device settings, such as mechanical ventilators, to reduce mortality and shorten the length of stay for critically ill patients worldwide.
  • EquityQuotient, from New York City, is a healthcare intelligence platform that automates compliance and provides actionable insights by aggregating public, private, and first-party data, using proprietary analytics to help leaders address disparities, improve outcomes, and lower care costs.
  • Also from New York City, Ethermed's AI-powered solution streamlines prior authorizations, eliminating up to 90 percent of auths and 70 percent of the labor involved. Ethermed requires no workflow changes, is fully auditable, and offers aligned incentives from a mission-driven, human-focused company.
  • Fibricheck, based in Hasselt, Belgium, transforms ordinary smartphones into regulated digital heart rhythm monitors, offering unparalleled access to cardiovascular diagnostics for patients and streamlined workflows for physicians.
  • Austin-based NearWave has developed a non-invasive, AI-powered handheld imaging device that can predict breast cancer therapy response within seven days.
  • Pragmaclin, founded in Newfoundland, Canada, developed a cutting-edge PRIMS (Parkinson’s Remote Interactive Management System) that leverages depth cameras and machine learning to monitor and assess Parkinson’s Disease symptoms, offering healthcare professionals remote and in-clinic insights to enhance treatment decisions.
  • Somnair, a Baltimore, Maryland, company, is developing a non-invasive neurostimulation oral appliance for treating obstructive sleep apnea, offering a sleek, retainer-sized device that provides an effective alternative to CPAP or invasive surgery for millions of patients.
  • Vancouver, Canada-headquartered Total Flow Medical is developing solutions to enhance the quality of care and life for patients requiring the use of a heart-lung machine during surgery or life support.
  • Tympulse, hailing from Dublin, Ireland, is commercializing TympanoColl, an innovative and disruptive solution for eardrum (Tympanic Membrane) repair in an outpatient setting through the ear canal.
  • Perth, Australia-based Vital Trace is developing a continuous lactate monitor for real-time, accurate detection of fetal distress.
  • New York City's WorkUp is a healthcare-specific talent pipeline management platform that connects students with tailored resources for their clinical career journey, providing personalized support as their needs evolve.

University of Houston-founded company secures $2.5M in NIH grant funding

all in the timing

You could say that the booming success of Houston biotech company CellChorus owes very much to auspicious TIMING. Those six letters stand for Time-lapse Imaging Microscopy In Nanowell Grids, a platform for dynamic single-cell analysis.

This week, CellChorus announced that the company, along with The University of Houston, has been awarded up to $2.5 million in funding from the National Center for Advancing Translational Sciences (NCATS) at the National Institute of Health. A $350,000 Phase I grant is already underway. Once predetermined milestones are achieved, this will lead to a two-year $2.1 million Phase II grant.

The TIMING platform was created by UH Single Cell Lab researchers Navin Varadarajan and Badri Roysam. TIMING generates high-throughput in-vitro assays that quantitatively profile interactions between cells on a large scale, particularly what happens when immune cells confront target cells. This has been especially useful in the realm of immuno-oncology, where it has demonstrated its power in designing novel therapies, selecting lead candidates for clinical trials and evaluating the potency of manufactured cells.

“By combining AI, microscale manufacturing and advanced microscopy, the TIMING platform yields deep insight into cellular behaviors that directly impact human disease and new classes of therapeutics,” says Rebecca Berdeaux, chief scientific officer at CellChorus. “The generous support of NCATS enables our development of computational tools that will ultimately integrate single-cell dynamic functional analysis of cell behavior with intracellular signaling events.”

Houston’s CellChorus Innovation Lab supports both the further development of TIMING and projects for early-access customers. Those customers include top-25 biopharmaceutical companies, venture-backed biotechnology companies, a leading comprehensive cancer center and a top pediatric hospital, says CEO Daniel Meyer.

CellChorus’s publications include papers written in collaboration with researchers from the Baylor College of Medicine, Houston Methodist, MD Anderson, Texas Children’s Hospital, the University of Texas and UTHealth in journals including Nature Cancer, Journal of Clinical Investigation and The Journal for ImmunoTherapy of Cancer.

The new Small Business Technology Transfer (STTR) award will specifically support the development of a scalable integrated software system conceived with the goal of analyzing cells that are not fluorescently labeled. This label-free analysis will be based on new AI and machine learning (ML) models trained on tens of millions of images of cells.

“This is an opportunity to leverage artificial intelligence methods for advancing the life sciences,” says Roysam. “We are especially excited about its applications to advancing cell-based immunotherapy to treat cancer and other diseases.”

The Houston-born-and-bred company couldn’t have a more appropriate home, says Meyer.

“Houston is a premier location for clinical care and the development of biotechnology and life sciences technologies. In particular, Houston has established itself as a leader in the development and delivery of immune cell-based therapies,” the CEO explains. “As a spin-out from the Single Cell Lab at the University of Houston, we benefit from working with world-class experts at local institutions.”

In May, the company received a similar $2.5 million SBIR grant from NCATS at the NIH. Also this summer, CellChorus's technology was featured in Nature Cancer.

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