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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Axiom Space-tested cancer drug advances to clinical trials

mission critical

A cancer-fighting drug tested aboard several Axiom Space missions is moving forward to clinical trials.

Rebecsinib, which targets a cancer cloning and immune evasion gene, ADAR1, has received FDA approval to enter clinical trials under active Investigational New Drug (IND) status, according to a news release. The drug was tested aboard Axiom Mission 2 (Ax-2) and Axiom Mission 3 (Ax-3). It was developed by Aspera Biomedicine, led by Dr. Catriona Jamieson, director of the UC San Diego Sanford Stem Cell Institute (SSCI).

The San Diego-based Aspera team and Houston-based Axiom partnered to allow Rebecsinib to be tested in microgravity. Tumors have been shown to grow more rapidly in microgravity and even mimic how aggressive cancers can develop in patients.

“In terms of tumor growth, we see a doubling in growth of these little mini-tumors in just 10 days,” Jamieson explained in the release.

Rebecsinib took part in the patient-derived tumor organoid testing aboard the International Space Station. Similar testing is planned to continue on Axiom Station, the company's commercial space station that's currently under development.

Additionally, the drug will be tested aboard Ax-4 under its active IND status, which was targeted to launch June 25.

“We anticipate that this monumental mission will inform the expanded development of the first ADAR1 inhibitory cancer stem cell targeting drug for a broad array of cancers," Jamieson added.

According to Axiom, the milestone represents the potential for commercial space collaborations.

“We’re proud to work with Aspera Biomedicines and the UC San Diego Sanford Stem Cell Institute, as together we have achieved a historic milestone, and we’re even more excited for what’s to come,” Tejpaul Bhatia, the new CEO of Axiom Space, said in the release. “This is how we crack the code of the space economy – uniting public and private partners to turn microgravity into a launchpad for breakthroughs.”

Chevron enters the lithium market with major Texas land acquisition

to market

Chevron U.S.A., a subsidiary of Houston-based energy company Chevron, has taken its first big step toward establishing a commercial-scale lithium business.

Chevron acquired leaseholds totaling about 125,000 acres in Northeast Texas and southwest Arkansas from TerraVolta Resources and East Texas Natural Resources. The acreage contains a high amount of lithium, which Chevron plans to extract from brines produced from the subsurface.

Lithium-ion batteries are used in an array of technologies, such as smartwatches, e-bikes, pacemakers, and batteries for electric vehicles, according to Chevron. The International Energy Agency estimates lithium demand could grow more than 400 percent by 2040.

“This acquisition represents a strategic investment to support energy manufacturing and expand U.S.-based critical mineral supplies,” Jeff Gustavson, president of Chevron New Energies, said in a news release. “Establishing domestic and resilient lithium supply chains is essential not only to maintaining U.S. energy leadership but also to meeting the growing demand from customers.”

Rania Yacoub, corporate business development manager at Chevron New Energies, said that amid heightening demand, lithium is “one of the world’s most sought-after natural resources.”

“Chevron is looking to help meet that demand and drive U.S. energy competitiveness by sourcing lithium domestically,” Yacoub said.

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This article originally appeared on EnergyCapital.