Categories: Business

F.D.A. Clears Another Coronavirus Testing Kit for Use at Home

The Food and Drug Administration on Saturday granted emergency clearance for a coronavirus testing kit that will enable individuals to take a nasal sample at home and send it to a laboratory for diagnostic testing, the second such approval it has made.

Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health, said in a statement that the new test “not only provides increased patient access to tests, but also protects others from potential exposure.” Health care workers can risk infection when they administer diagnostic tests.

The kit, made by Everlywell, will contain a swab for individuals to use to take a sample from inside the nostrils, and a tube filled with a saline solution to put it in for sending to one of two private lab companies: Fulgent Therapeutics or Assurance Scientific Laboratories. The company plans to partner with additional laboratories.

Some public health researchers have warned that at-home nasal swab tests can be less accurate than the specimen collection performed by health care providers, which involves inserting a long nasal swab through the nose into the back of the throat.

Christina Song, an Everlywell spokeswoman, said consumers will first take an online screening survey to determine whether they meet federal guidelines for the test. The survey will be reviewed quickly by health care providers affiliated with PWNHealth, the company’s telemedicine partner. If a consumer qualifies for the test, one will be shipped out immediately.

“From the moment that you hit the order button, to the moment that you get the test results on your phone or device, that process is designed to take three to five days,” Ms. Song said.

The test kits will be available later this month, according to Ms. Song, and will cost $135.

In announcing its authorization for the Everlywell testing kit, the F.D.A. said the company had “leveraged” data from studies supported by the Bill and Melinda Gates Foundation and UnitedHealth Group to show that the specimens would stay stable during shipping.

Everlywell makes a variety of products that individuals can buy online or in stores, among them at-home test kits for diabetes, sexually transmitted diseases and high cholesterol.

Some of the company’s products, such as those purporting to test for food sensitivities, have come under criticism. Everlywell was also one of several businesses that drew attention from members of Congress in March for entering the market for coronavirus test kits in March without F.D.A. approval.

Everlywell, which had promoted its at-home kit as a consumer product, said in a statement at the time that it had not sold any of the kits to consumers, but was providing the test materials “at cost to hospitals and health care organizations who can commit to providing the test for free to their workers and patients.”

Jerry Rolon

After working for 7 years as a Internet Marketer, Jerry now aims to explore the journalistic side of Internet. With his impeccable knowledge in this domain, he churns out some of the best news articles from the internet niche. With respect to acedamics, Jerry earned a degree in business from California State University.

Recent Posts

XRP News Today: Find Mining Launches the World’s First Zero-Entry XRP Cloud Mining App, Helping You Convert XRP into Stable Passive Income

Hamptons, New York, 2nd Aug 2025, ZEX PR WIRE,  Find Mining, a leading global digital currency…

7 hours ago

Turn XRP’s Decline Into Daily Income — Find Mining Offers a Smarter Way to Profit Amid Falling Prices

Convert XRP’s price weakness into predictable, daily income—fully automated and risk-mitigated. Chicago, Illinois, 2nd August…

7 hours ago

Libre Capital Rebrands As Kaio, Unveils Tokenization Of $100m Bitcoin Yield Fund To Pioneer Next-gen Rwa Finance

Abu Dhabi, UAE, 31st July 2025, ZEX PR WIRE, Libre Capital, a pioneer in onchain…

7 hours ago

BTC, ETH, XRP Down: Sunny Mining Rolls Out Bonus Cloud Mining Plans to Turn Crypto into Daily Earnings

Miami, Florida, 2nd August 2025, ZEX PR WIRE, Recently, major cryptocurrencies have experienced a continued price…

7 hours ago

Synapse Power Opens Contributor Access to Build the Future of Decentralized AI Compute

Synapse Power invites global participants to contribute computing power to its GPU network—powering the next…

20 hours ago

Franklin Morgan & Associates Successfully Represented in DIAC Arbitration for $113M Award

New York, NY, 1st August 2025, Franklin Morgan & Associates is proud to announce that…

1 day ago