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 agencys 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 companys 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 companys 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.
The F.D.A.s announcement on Saturday follows other recent emergency use authorizations for coronavirus testing kits that also permit individuals to take samples at home. One, sold by LabCorp, also uses a nasal swab to collect a sample, which is then sent to the lab. The other, developed by a Rutgers University laboratory, called RUCDR Infinite Biologics, in partnership with Spectrum Solutions and Accurate Diagnostic Labs, is for collecting a saliva sample.
See the original post:
- More young people across the South are testing positive for coronavirus, officials warn - CNN - June 21st, 2020
- December deaths of California kids could be linked to coronavirus - Los Angeles Times - June 21st, 2020
- Russia reopens ahead of Victory Day and Putin referendum -- but coronavirus threat remains - CNN - June 21st, 2020
- White House adviser: Trump administration preparing for possible second wave of coronavirus in the fall - CNN - June 21st, 2020
- Arizonans see big jump in coronavirus cases, but don't see reason to wear masks - CNN - June 21st, 2020
- In Beijing it looked like coronavirus was gone. Now we're living with a second wave - The Guardian - June 21st, 2020
- Beijing's new outbreak is a reminder to the world that coronavirus can return at anytime - CNN - June 21st, 2020
- Coronavirus pandemic: What you need to know in Asheville, WNC, June 21 - Citizen Times - June 21st, 2020
- You May Have Antibodies After Coronavirus Infection. But Not for Long. - The New York Times - June 21st, 2020
- Coronavirus shuts down Crowbar, the Orpheum and Skippers Smokehouse - Tampa Bay Times - June 21st, 2020
- Second wave of coronavirus cases? Experts say were still in the first - The Denver Post - June 21st, 2020
- Florida sets another single-day coronavirus case record with nearly 4,000 infections - Tampa Bay Times - June 21st, 2020
- Tens of thousands of Britons have died from coronavirus. But Boris Johnson is stoking a culture war. - CNN - June 21st, 2020
- Coronavirus: What's happening around the world on Sunday - CBC.ca - June 21st, 2020
- Flushing the Toilet May Fling Coronavirus Aerosols All Over - The New York Times - June 21st, 2020
- NJ hits top ranking in coronavirus analysis, showing positive trends and signs of hope - NorthJersey.com - June 21st, 2020
- Texas Governor Says 'No Reason Today To Be Alarmed' As Coronavirus Cases Set Record - NPR - June 21st, 2020
- Putin has a 'disinfection tunnel,' Sweden feels isolated over coronavirus - CNBC - June 21st, 2020
- Coronavirus response | Your visit to campus will be different this fall but how much? - Champaign/Urbana News-Gazette - June 21st, 2020
- Lessons on Coronavirus Testing From the Adult Film Industry - The New York Times - June 21st, 2020
- How to have summer fun amid the coronavirus pandemic - CNBC - June 21st, 2020
- America's response to the coronavirus is the most American thing ever - CNN - May 19th, 2020
- Illinois Threatens to Fine Defiant Businesses as Reopening Tensions Rise Nationally - The New York Times - May 19th, 2020
- A.C.L.U. Warns Against Fever-Screening Tools for Coronavirus - The New York Times - May 19th, 2020
- Coronavirus pandemic in the US: Live updates - CNN International - May 19th, 2020
- Staying safe isn't just about hygiene and distance. It's about time, too. - CNN - May 19th, 2020
- 'Something we've never seen before': Scientists still trying to understand baffling, unpredictable coronavirus - USA TODAY - May 19th, 2020
- What you need to know about coronavirus on Monday, May 18 - CNN - May 19th, 2020
- Coronavirus Testing For The Dead? It Can Help Reveal The Scope Of The Pandemic : Shots - Health News - NPR - May 19th, 2020
- The Pandemics Long-Lasting Effects on Weddings - The Atlantic - May 19th, 2020
- Exclusive: Lack of immunity means China is vulnerable to another wave of coronavirus, top adviser warns - CNN - May 19th, 2020
- U.S. and China Trade Coronavirus Accusations, Sparking Fears of a New Cold War - The New York Times - May 19th, 2020
- Pompeo backs away from theory he and Trump were pushing that coronavirus originated in Wuhan lab - CNN - May 19th, 2020
- Does Texas really rank high in coronavirus recoveries? - The Texas Tribune - May 19th, 2020
- The pastor of a northern California church that held a Mother's Day livestream service has tested positive for coronavirus - CNN - May 19th, 2020
- The recovery from coronavirus could take years - CNN - May 19th, 2020
- The coronavirus exposed the US' reliance on India for generic drugs. But that supply chain is ultimately controlled by China - CNN - May 19th, 2020
- Delaware County Woman Claims She Contracted Coronavirus After Nursing Home Staff Placed Positive Patients In Her Room - CBS Philly - May 19th, 2020
- Massachusetts and Connecticut become the final states to begin reopening - CNN - May 19th, 2020
- My Cancer Doesnt Care About the Coronavirus - The New York Times - May 19th, 2020
- Coronavirus Is Making Young People Very Sick. I Was One of Them. - The New York Times - May 19th, 2020
- 5 Things To Watch This Week In Politics And Coronavirus - NPR - May 19th, 2020
- Where New Yorkers Moved to Escape Coronavirus - The New York Times - May 19th, 2020
- WHO warns it could take up to 5 years before the coronavirus pandemic is under control - CNBC - May 19th, 2020
- Coronavirus Live News: Updates and Analysis - The New York Times - May 12th, 2020
- Coronavirus updates: 'Disturbing situation' with COVID-associated illness, Cuomo says - ABC News - May 12th, 2020
- Fauci warns again about the US reopening as more evidence emerges of virus's early spread - CNN - May 12th, 2020
- Coronavirus Vaccine FAQs: How Is It Being Developed? When Will It Be Ready? : Goats and Soda - NPR - May 12th, 2020
- What you need to know about coronavirus on Tuesday, May 12 - CNN - May 12th, 2020
- About 100 N.Y. Children Treated for Illness Tied to Virus: Live Updates - The New York Times - May 12th, 2020
- 5 things to know for May 12: Coronavirus, health, economy, SCOTUS, Mexico - CNN - May 12th, 2020
- Where is the coronavirus in N.J.? Latest map, update on county-by-county cases. (May 12, 2020) - NJ.com - May 12th, 2020
- Ranked: The 10 US Cities Best Positioned To Recover From Coronavirus (And The 10 Worst) - Forbes - May 12th, 2020
- CNN Poll: Negative ratings for government handling of coronavirus persist - CNN - May 12th, 2020
- How we 'Leeeeroy Jenkins'-ed the coronavirus reopening - CNN - May 12th, 2020
- Were All Casualties of Trumps War on Coronavirus Science - The New York Times - May 12th, 2020
- Some companies are part of the coronavirus economy. The rest are in trouble - CNN - May 12th, 2020
- Mitch McConnell: Obama 'should have kept his mouth shut' instead of criticizing US coronavirus response - CNN - May 12th, 2020
- This is what happens to the pets left behind when their owners die from coronavirus - CNN - May 12th, 2020
- Coronavirus is the ultimate demonstration of the real-world impact of racism - The Guardian - May 12th, 2020
- Coronavirus in Chicago: A running list of restaurants that have closed - Eater Chicago - May 12th, 2020
- The Folly of Trumps Blame-Beijing Coronavirus Strategy - The New Yorker - May 12th, 2020
- This Baseball Mascot Was Struck Out By The Coronavirus Pandemic - NPR - May 12th, 2020
- I negotiated canceled flights, an unknown carrier and a 'sleep box' to get to my son - CNN - May 12th, 2020
- Tony Shalhoub reveals that he and his wife have recovered from coronavirus - CNN - May 12th, 2020
- What Donald Trump can learn from Boris Johnson as coronavirus cases are found in White House - CNN - May 12th, 2020
- 10-4: How to Reopen the Economy by Exploiting the Coronaviruss Weak Spot - The New York Times - May 12th, 2020
- The Problem With Stories About Dangerous Coronavirus Mutations - The Atlantic - May 12th, 2020
- Coronavirus: CSU to have mainly online classes in fall 2020 - Los Angeles Times - May 12th, 2020
- My Coronavirus Patients Are Struggling to Recover - The New York Times - May 12th, 2020
- Once the coronavirus 'epicenter,' this American city reversed course - CNN - May 9th, 2020
- Travel Reopenings Amid the Coronavirus Pandemic - The New York Times - May 9th, 2020
- Coronavirus has created a rift between the US and China that may take a generation to heal - CNN - May 9th, 2020
- Youll Probably Never Know If You Had the Coronavirus in January - The Atlantic - May 9th, 2020
- May 8 evening update: The latest on the coronavirus and Maine - Bangor Daily News - May 9th, 2020
- Federal Watchdog Says Coronavirus Whistle-Blower Should Be Reinstated as It Investigates - The New York Times - May 9th, 2020
- One of Trump's personal valets has tested positive for coronavirus - CNN - May 9th, 2020
- Do Antibodies Against The Novel Coronavirus Prevent Reinfection? : Shots - Health News - NPR - May 9th, 2020
- The Amazon's gateway city is struggling to battle the coronavirus - CNN - May 9th, 2020
- The coronavirus appears to have mutated. What does that mean for contagiousness? - NBC News - May 9th, 2020