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.

The results are in for Houston-based Saranas' clinical trials. Courtesy of Saranas

Houston early bleeding detection device company reveals results of its clinical trials

blood tests

A Houston-based startup is closer to taking flight with a medical device designed to catch bleeding complications during medical procedures that involve blood vessels.

On May 22, researchers presented the results of a study showing the Early Bird Bleed Monitoring System from Houston-based Saranas Inc. detected various levels of bleeding in 63 percent of the patients who underwent endovascular procedures. These procedures treat problems, such as aortic aneurysms, that affect blood vessels.

No troubles were reported with the Early Bird device during the clinical trial, the researchers say.

Before this study, the Early Bird device hadn't been tested in humans. In all, 60 patients in five states participated in the clinical trial, which ran from August to December last year. Findings of the study were unveiled at the Society for Cardiovascular Angiography Interventions 2019 Scientific Sessions in Las Vegas.

The study's authors say they plan to continue evaluating the device at medical institutions that want to better manage bleeding during endovascular procedures.

"This is the first time we're seeing how this device could help in a real-world patient setting, and we were very encouraged by the results. Right now, patients have a risk of vessel injury when undergoing endovascular procedures where the femoral artery or vein is used for vascular access," Dr. Philippe Genereux, principal investigator for the study and a cardiologist at Morristown Medical Center in Morristown, New Jersey, says in a news release.

"This technology allows us to detect bleeding in real-time," Genereux adds, "which means we can take action quickly and improve the outcomes of the procedure and recovery for the patient."

In March, the Early Bird device — invented at Houston's Texas Heart Institute — received the U.S. Food and Drug Administration's approval as a "novel" medical device.

Saranas says Early Bird is the first and only device of its type. The FDA approval and the promising results of the clinical trial pave the way for the eventual launch of the device into the healthcare market.

A forecast from professional services firm KPMG predicts the global market for medical devices will reach nearly $800 billion by 2030. Early Bird aims to capture a sliver of that market by addressing an expensive and potentially fatal problem. One-fifth of patients experience bleeding complications during large-bore endovascular procedures. Research shows these complications are associated with a greater risk of death, longer hospital stays, and higher healthcare costs.

The Early Bird device is meant to decrease those complications by quickly alerting medical professionals to signs of bleeding during endovascular procedures.

As explained by the Texas Heart Institute, the Early Bird employs a sheath — a plastic tube that helps keep arteries and vessels open — embedded with sensors that measure the electrical resistance across a blood vessel. When the Early Bird senses a change in the electrical resistance, medical professionals receive audible and visual notifications about potential internal bleeding. If detected early, this bleeding can be minimized.

Altogether, Saranas has raised $12 million from investors, including a $2.8 million round in May 2018. The company was founded in 2013.

"What attracted me to Saranas is that our solution has the potential to meaningfully reduce serious bleeding complications that worsen clinical outcomes and drive up healthcare costs," says Zaffer Syed, who joined the startup as president and CEO in 2017. "In addition, our device may support access of important minimally invasive cardiac procedures by allowing them to be performed more safely."

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

where to be

It's time to look at what's on the agenda for April 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.

Note: This post might be updated to add more events.

April 4 — A.I. Digital and the Future of Energy

In the latest installment of UH Energy's "Critical Issues in Energy" Symposium Series, the speakers will take a deeper dive into the role of A.l. within the energy marketplace, specifically with what is being done with A.I. and what is capable of being done. In addition to this pivotal look at one crucial aspect of the energy transition, attendees will be afforded networking opportunities with speakers and distinguished guests, and food/refreshments will be provided.

The event is Tuesday, April 4, from 5:30 to 7:30 pm, at the University of Houston. Click here to register.

April 5 — Creating & Sustaining Innovation & Entrepreneurship

Join us for a fireside chat discussing the growth of entrepreneurship & a panel on demystifying the patent process.

The event is Wednesday, April 5, from 9 to 11:30 am, at the Ion. Click here to register.

April 5 — HAN Angel Academy

Learn angel investing best practices from Capital Factory co-founder and chairman, Gordon Daugherty in a half-day bootcamp format for accredited investors.

The event is Wednesday, April 5, from 11 am to 4 pm, at Rice University - Shell Auditorium. Click here to register.

April 11 — Future of Health Care

The Greater Houston Partnership's inaugural Future of Health Care event highlights one of the region's major industry sectors driven by world-class institutions and professional talent.

The event is Wednesday, April 11, from 10:30 am to 1:30 pm, at the Royal Sonesta. Click here to register.

April 11 — Idea to Impact: Navigating the Challenges to Commercializing University Discoveries

Amazing discoveries are made in university labs every day, yet most of them never develop into widely accessible commercial products. Why? And what can universities do to change that? As part of Rice University's "Betterment of the World" Scientia Lecture Series, join Rice Business on April 11 at 4 pm virtually or in person (Shell Auditorium, McNair Hall) to hear Yael Hochberg, Professor in Entrepreneurship at the Jones Graduate School of Business, as she discusses the challenges in commercializing university research discoveries.

The event is Wednesday, April 11, from 4 to 5 pm, at Rice University and online. Click here to register.

April 11 — Greentown Houston Climatetech Career Fair 2023

Greentown Labs and ALLY Energy welcomes all professionals, students, and soon-to-be graduates to join us for the Greentown Houston Career Fair, which focuses on connecting professionals directly with Greentown Houston’ network of founders, CEOs, and cutting-edge climatetech startups looking for bright and eager talent.

The event is Tuesday, April 11, from 4:30 to 6:30 pm, at Greentown Houston. Click here to register.

April 15 — Earth Day Clothing Swap Party with Sustainable Fashion & Earth Month HTX

A clothing swap is a fun, alternative solution to thrift shopping or secondhand fashion that allows you to clean out the clothes you no longer wear and in return bring home new additions to your closet - all for free and hosted by Houston startup RESTATEMENT.

The event is Saturday, April 15, from noon to 5 pm, at Patterson Park. Click here to register.

April 17-18 — AI Powered Renewable Energy Workshop

AI Houston Institute of Rice University in partnership with Ion is getting together experts from academia and industry working on the application of artificial intelligence in solving some of the most complex challenges facing the Energy industry as it transitions into alternative sources of energy that are green and sustainable.

The event is Monday, April 17, to Tuesday, April 18, at the Ion. Click here to register.

April 19 — Investor Studio Series: Dream Big Ventures x Ion x Mendoza Ventures

Underrepresented founders face a lot of barriers, including rarely seeing VC dollars. However, Dream Big Ventures and Mendoza Ventures are looking to change those statistics to help diverse founders succeed. Join Dream Big Ventures Founder and CEO Staci LaToison, and Mendoza Ventures Co-Founders Senofer Mendoza and Adrian Mendoza, as they discuss the growth of women and Latinas in Fintech, AI, and Cybersecurity in this fireside chat.

The event is Wednesday, April 19, from 5 to 7 pm, at the Ion. Click here to register.

April 19 — The H. Albert Napier Rice Launch Challenge Championships

Join Liu Idea Lab for Innovation and Entrepreneurship and support Rice University student ventures at the H. Albert Napier Rice Launch Challenge (NRLC) Championships on Wednesday, April 19. Five student finalists will pitch their ventures to compete for the chance to win a share of $100,000 in equity-free funding.

The event is Wednesday, April 19, from 5:30 to 9 pm, at Rice University. Click here to register.

April 20 — Female Founders and Funders

Calling all rockstar female founders and investors in the Houston area. Mark your calendars for this month's Female Founders and Funders meetup. Coffee and breakfast is provided and the event is free to attend.

The event is Thursday, April 20, from 9 to 10 am, at Sesh Coworking. Click here to register.

Texas researchers name ancient beaver fossil after favorite Texas gas station

Beaver Country

The legend of a treasured gas station chain continues with a new chapter: a rediscovered beaver fossil is being named after Buc-ee’s.

The ancient animal was named Anchitheriomys buceei (A. buceei) by Steve May, a research associate at the University of Texas Jackson School of Geosciences and lead author of the Palaeontologia Electronica paper that describes the beaver.

A. buceei fossils were rediscovered by researchers in UT Austin’s collections and include fossils from six different Texas sites. May decided to name A. buceei after Buc-ee’s after spotting a “This is Beaver Country” billboard in 2020 that reminded him of the fossils he was studying at the time.

Though Buc-ee’s was founded in 1982, CEO Arch “Beaver” Alpin III said in a press release that his business’ history is longer than he thought, and that he may “need to rethink [their] beginnings.”

Occurrences of A. buceei can be found between 15 and 22 million years ago along the state’s gulf coast. At first glance, they don’t appear much different from current native Texas beavers. But according to the report’s co-author Matthew Brown, who is also the director of the Jackson School’s vertebrate paleontology collections, they are nearly 30 percent bigger than today’s beavers.

A partial skull fossil of the beaver was originally collected in 1941 by paleontologists. One of the original finders was Texas A&M University museum curator Curtis Hesse, who passed away four years later before he could name it a new species and publish his study.

More information about A. buceei can be found on UT Austin’s website.

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This article originally ran on CultureMap.