At-home COVID-19 test by Texas-based company approved by FDA - Chron
At-home COVID-19 test by Texas-based company approved by FDA - Chron |
| At-home COVID-19 test by Texas-based company approved by FDA - Chron Posted: 19 May 2020 06:55 PM PDT 
The FDA on Saturday approved a testing kit by digital health company Everlywell, which allows a consumer to take a nasal sample at home and send it to a laboratory for the diagnosis. The FDA on Saturday approved a testing kit by digital health company Everlywell, which allows a consumer to take a nasal sample at home and send it to a laboratory for the diagnosis. An Austin-based company has been granted emergency clearance by the U.S. Food and Drug Administration (FDA) for an at-home COVID-19 testing kit. The FDA on Saturday approved a testing kit by digital health company Everlywell, according to a Monday release. The kit allows a consumer to take a nasal sample at home and send it to a laboratory for the diagnosis. Retailers: Pier 1 to permanently close stores after COVID-19 upends sale The decision comes after the FDA blocked several companies that have developed at-home testing kits, including Everlywell, from the market in March over concerns that they would not be administered accurately. "We appreciate the FDA's close partnership and guidance in issuing this authorization," chief medical and scientific officer at Everlywell Dr. Frank Ong said in the release."Working with a growing number of authorized laboratories over time enables Everlywell to scale COVID-19 testing for Americans where they need it most - in their homes." The kits will be available later this month for $109 each. It comes with a short nasal swab, digital screening questionnaire and instructions on how to ship samples to the private lab company. Within 48 hours of the sample being received by the lab, results will be reviewed by an independent physician. A positive result includes a telehealth consult and is reported to mandated federal and local public health agencies. The shorter, Q-tip–like swab included with the at-home kit does not extend deep into people's nasal passage into the back of the throat like the long nasal swabs used by healthcare providers, with some experts warning that results could be less accurate. Everlywell, founded in 2015, also makes at-home test kits for cholesterol, thyroid function and sexually transmitted diseases.  |
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