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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TMC names inaugural cohort for unique accelerator with UK

coming to HOU

Sixteen digital health and medical device startups founded in the United Kingdom have been selected for a customized accelerator at the Texas Medical Center's Innovation Factory.

In partnership with Innovate UK, TMCi created the Innovate UK Global Incubator Programme, a new accelerator that supports UK businesses as they build their United States go-to-market plan. The program builds the BioBridge relationship between TMC and the UK that was originally established five years ago.

“The TMC UK BioBridge program was launched with the UK Department for Business and Trade in 2018 to serve as a gateway for advancing life sciences and foster innovation and research between our two countries," says Ashley McPhail, chief external affairs and administration officer for TMC, in a news release. "We saw an opportunity to work with Innovate UK to develop a larger program with the UK after the success of the 11 companies that previously participated in our health tech accelerator."

The 16 companies will participate in the program from June to November. The cohort is expected to arrive in Houston on June 5 and have access to TMCi's facilities, network of mentors and potential clients, funding, potential customers, and curated programing — all while being a unique entry point into the US. The new offering joins three other globally recognized curriculums: Biodesign, Accelerator for Cancer Therapeutics, and Health Tech.

“TMCi nurtures long-term growth, development, and competitiveness to increase startups chances of success and global expansion," says Emily Reiser, associate director of TMC Innovation. "By bringing their novel technologies and exposing them to a curated selection of TMC’s expert network, startups receive support and evaluation to build, scale, and expand in the US market."

Two of the cohort's specialties include cardiovascular and oncology — two of TMC's strongest areas of expertise — with solutions ranging from surgical devices to AI-enabled risk stratification and hospital efficiency.

Innovate UK is the country's national innovation agency dedicated to supporting business-led innovation in all sectors.

“The United Kingdom is fully committed to improving global healthcare through scientific collaboration," says His Majesty’s Consul General in Texas Richard Hyde in the release. "Through the expansion of the TMC UK BioBridge and in partnership with Innovate UK, this programme will help to expose the brightest and best British companies to the world’s largest medical city. Our companies will collaborate and grow as they work to develop cutting edge technology. The partnership between the UK Government and TMC demonstrates that international collaboration can drive both economic growth and improvement to quality of life.”

The 16 companies making up the inaugural cohort are as follows, according to TMC.

AINOSTICS aims to revolutionize the treatment and prevention of neurological conditions, such as dementia, by developing innovative AI-enabled solutions that draw novel insights from routinely acquired non-invasive medical scans to deliver accurate diagnosis and outcome prediction, and in turn facilitate personalized care and timely access to disease-modifying treatments for patients.
Alvie is a blended human plus AI-enabled digital solution providing personalised pre and rehabilitation coaching and supportive care for cancer and surgery. Alvie's technology combines data profiling, risk-stratification and tailored prescriptions of health and well-being with curated educational content, targeted behaviour change coaching and expert support through chat messaging and virtual consultations.
C the Signs™ is a validated AI cancer prediction platform, which can identify patients at risk of cancer at the earliest and most curable stage of the disease. Used by healthcare professionals, C the Signs can identify which tumor type a patient is at risk of and recommend the most appropriate next step in less than 30 seconds. The platform has detected over 10,000 patients with cancer, with over 50 different types of cancer diagnosed, and with a sensitivity of >98% for cancer.
At PEP Health, We believe all patients deserve the best care possible. Our cutting-edge machine-learning technology enables healthcare organisations, regulators, and insurers the real-time, actionable insights they need to have a direct and dramatic impact on patient experiences.
PreciousMD improves the lives of lung-cancer and other lung-related illnesses patients worldwide by enabling imaging-based diagnostics needed for personalized treatment pathways.
Ufonia is an autonomous telemedicine company, we use large language models and voice AI to increase the capacity of clinical professionals.
My mhealth offers digital therapeutics for a range of long-term conditions- COPD, Asthma, Diabetes and Heart Disease. Our product has been successfully deployed in the UK and India, with >100,000 users registered to date. Our solutions empower patients to self-manage their conditions, resulting in dramatic improvements in outcomes, as evidenced through multiple clinical trials and real-world evaluations.
At Surgery Hero, we offer a clinically backed solution that ensures whole-human support before and after surgery. We help health systems, employers and health plans cut costs without sacrificing quality of care.
Panakeia's software platform enables extremely rapid multi-omics profiling in minutes directly from routinely used tissue images without needing wet lab assays.
QV Bioelectronics are striving to deliver longer, better quality lives for brain tumour patients. Using their first-of-its-kind implantable electric field therapy device, GRACE, QV will provide effective, focal & continuous treatment without impacting patient quality of life.
52 North is a med-tech company focused on improving health outcomes and health equity by reinventing care pathways. The NeutroCheck® solution is a finger-prick blood test and digital platform built to significantly improve safety and quality of life for cancer patients, by helping to identify at-home those patients who are at risk of the most fatal side-effect of chemotherapy: neutropenic sepsis.
Somnus is fulfilling an unmet need in global healthcare by developing real-time, point of care blood propofol monitoring. Its products will improve the care of sedated and anaesthetised patients, save money for hospitals, and facilitate a major reduction in greenhouse gas emissions.
ScubaTx is a breakthrough organ transplant preservation company established to solve the global unmet need for cost-efficient and longer-duration organ preservation technology. ScubaTx has developed a simple, small and affordable device which uses Persufflation to extend the preservation of organs.
IBEX is on a mission to help people live active, healthy and productive lives by increasing their access to early diagnosis of osteoporosis. The IBEX BH software as medical device delvers routine, automated assessment of fracture risk from routine radiology for earlier detection and more equitable treatment of osteoporosis.
NuVision produces products derived from donated human amniotic membrane that are used in ophthalmology to help patients with chronic, traumatic and post-surgical wounds of the eye to be treated earlier and recover more fully and more quickly. The company’s products are also used in the management of dry eye disease, a debilitating conditions that affects around 17m people in the USA.
Calon Cardio-Technology is on a mission to improve quality of life for patients with Left Ventricular Assist devices (LVAD) and reduce the common post operative complications associated with these implantable heart pumps. We plan to do this by introducing a completely wireless heart pump system and augment patient follow-up with built-in remote monitoring capabilities.

UH lab using mixed reality to optimize designs for the Moon and Mars

hi, tech

University of Houston researchers and students are bringing multiple realities together to help improve the design process for crewed space missions.

Helmed by Vittorio Netti, a researcher for UH and a space architect, the university has launched an XR Lab within the University of Houston architecture building. The lab allows researchers to combine mixed reality (MR), virtual reality (VR), augmented reality (AR) and extended reality (XR) to "blend the physical and digital worlds" to give designers a better understanding of life in space, according to a release from UH.

In the lab researchers can wear MY space suits and goggles, take a VR space walk, or feel what it's like to float to the International Space Station with the help of XR and a crane.

The area in which the researchers conduct this work is known as the "cage" and was developed during a six-month research and design study of lunar surface architecture sponsored by Boeing, which aimed to learn more about the design of a lunar terrain vehicle and a small lunar habitat.

The work is part of UH's Sasakawa International Center of Space Architecture (SICSA), which is led by Olga Bannova, a research associate professor and director of the space architecture graduate program at UH.

She says work like this will drastically cut down research and development time when designing space structures.

“These technologies should be harnessed to mitigate the dependency on physical prototyping of assets and help optimize the design process, drastically reducing research-and-development time and providing a higher level of immersion,” Bannova said in a statement.

Today the research team is shifting its focus on designing for a Mars landing. In the future, they aim to demonstrate and test the system for habitats designed for both lunar and Martian surfaces. They are also working with Boeing to test designs in microgravity, or zero gravity, which exists inside the International Space Station.

Mixed Reality Raising the Bar for Space Architecture on the Moon and MarsStep into this 'Cage' at the University of Houston where physical and digital worlds are merged, allowing students to see and ...

5 most popular innovation stories in Houston this week

what's trending

Editor's note:Another week has come and gone, and it's time to round up the top headlines from the past few days. Trending Houston tech and startup news on InnovationMap included June business events not to miss, innovators to know, and more.

3 Houston innovators to know this week

This week's roundup of Houston innovators includes Ramanan Krishnamoorti of UH, Valerie Tompson of SWAN Impact Network, Evan Erickson of TexPower Technologies. Photos courtesy

In this week's roundup of Houston innovators to know, I'm introducing you to three local innovators across industries — from battery tech to impact investing — recently making headlines in Houston innovation. Read more.

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

Check out these conferences, pitch competitions, networking, and more in the month of June. Photo via Getty Images

It's time to look at what's on the agenda for June for Houston innovators — from pitch competitions to networking events.

Here's a roundup of events not to miss this month. Mark your calendars and register accordingly. Read more.

Texas angel investor group expands to make impact in Houston

Austin-founded SWAN Impact Network has entered the Houston innovation ecosystem. Photo via Getty Images

An angel investment network founded in Austin has announced its entrance into the Houston market.

SWAN Impact Network, which focuses on funding early-stage, impact-driven startups, announced that Houston will be its next market expansion. Founded in 2016, the organization expanded to Dallas two years ago. Now, SWAN is hitting the Bayou City and is actively looking for potential angel investors to join its network.

"Houston is the logical place for us to go because a lot of our deep expertise we developed is grounded around life science, health and wellness, and environmental," Bob Bridge, executive director of SWAN, tells InnovationMap. "There's a lot of people in Houston in the spaces where we've spent most of our time and money." Read more.

Houston digital health startup acquired by Illinois-based company

Houston-based Melax Tech has been acquired. Photo via MelaxTech.com

A Houston startup has exited to a clinical terminology management and data quality solutions company.

Melax Technologies Inc., an artificial intelligence and natural language processing technology company, has been acquired by Intelligent Medical Objects, which is headquartered in the Chicago area. It's the first acquisition for IMO, and the deal will allow for the company to expand its offerings to various segments in the health care market.

"Today marks an exciting moment for IMO as we complete our first acquisition,” says Ann Barnes, CEO at IMO, in a news release. “Combining Melax Tech’s analytics and NLP capabilities with IMO’s clinical terminology and data quality platform will enable healthcare organizations to have a more comprehensive solution for both clinical operation and research. Read more.

Houston health care institution secures $100M for expansion, shares renderings

Baylor College of Medicine's Lillie and Roy Cullen Tower is set to open in 2026. Rendering courtesy of SLAM Architecture

Baylor College of Medicine has collected $100 million toward its $150 million fundraising goal for the college’s planned Lillie and Roy Cullen Tower.

The $100 million in gifts include:

A total of $30 million from The Cullen Foundation, The Cullen Trust for Health Care, and The Cullen Trust for Higher Education.
$12 million from the DeBakey Medical Foundation
$10 million from the Huffington Foundation
More than $45 million from members of Baylor’s Board of Trustees and other community donors, including the M.D. Anderson Foundation, the Albert and Margaret Alkek Foundation, and The Elkins Foundation.

“The Cullen Trust for Health Care is very honored to support this building along with The Cullen Foundation and The Cullen Trust for Higher Education,” Cullen Geiselman Muse, chair of The Cullen Trust for Health Care, says in a news release. “We cannot wait to see what new beginnings will come from inside the Lillie and Roy Cullen Tower.” Read more.

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