After telling companies, laboratories and state health departments to move forward with emergency coronavirus testing without federal oversight or approval, the FDA is now working to rein in the ones it describes as going too far.
To boost the nation’s access to much-needed diagnostics, the agency allowed certain certified laboratories and manufacturers to proceed with their own clinical tests for COVID-19—provided they validate the tests themselves and submit their data and official applications to the FDA within 15 days for review.
Now, as the agency combats fake tests being shipped to the U.S. from overseas, telehealth companies that are just starting to offer home-based tests—where a person purchases a kit online, collects a sample themselves and then mails it to a laboratory for a result—could be caught in the middle, facing new hurdles.
In addition, while their labs may be in compliance with the FDA’s new policies, people in their homes—where collecting an uncontaminated specimen for a sensitive molecular sequencing test can be a delicate, complex matter—may not be.
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Previously, an FDA advisory panel in 2016 examined the potential of at-home and over-the-counter testing for infectious diseases such as the flu, strep throat and HIV.
The agency said that nasopharyngeal swabs—such as the ones currently used to collect coronavirus samples by reaching deep into the rear chambers of the nose—could be ineffective in the hands of untrained users and could weaken the ability of a test to give correct results without vigorous swabbing.
At the time, FDA staff instead pushed test manufacturers to explore recruiting healthcare professionals to collect specimens at urgent care locations, drugstores, university health clinics and child care centers.
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In a statement Friday, FDA Commissioner Stephen Hahn and acting Associate Commissioner for Regulatory Affairs Judith McMeekin said the agency has not yet authorized any COVID-19 product for home testing.
And while it has been working with companies in this space to help develop legitimate tests, the agency’s missive denounced such offerings in strong terms.
“Fraudulent health claims, tests, and products can pose serious health risks. They may keep some patients from seeking care or delay necessary medical treatment,” Hahn and McMeekin said. “The FDA will take appropriate action to protect consumers from bad actors who take advantage of a crisis to deceive the public by marketing tests that pose risks to patient health. This may include issuing warning letters, seizures or injunctions.”
"Additionally, we are stepping up enforcement at ports of entry, including International Mail Facilities, to ensure these fraudulent products that originate outside the country do not enter through our borders," they added.
In the past week, home telehealth companies Everlywell, Nurx and others detailed their plans to offer mail-in coronavirus tests to the public—while noting they believed they were following the FDA’s newly loosened and evolving Emergency Use Authorization regulations for COVID-19 testing.
Everlywell was set to begin shipping 30,000 home test kits Monday, March 23, while Nurx said on its website over the weekend that it had already reached its daily test kit capacity. Priced at $135 and $181 apiece, both said they were offering their tests at cost, with no profits going to the companies.
In a statement to FierceMedTech, Everlywell said it shares the FDA's concerns regarding fraudulent test kits. "Every lab that we are working with to provide COVID-19 testing has had their validation data and reports reviewed by the FDA under the Emergency Use Authorization framework," the company said. "Everlywell is working directly with the FDA to understand any additional regulatory requirements that may apply to at-home collection kits, and is looking forward to partnering with the FDA in our shared mission to provide safe, accurate and affordable testing for all Americans who need it."
Meanwhile, New York City-based health concierge company Radish Health launched what it described as an "FDA approved at-home COVID-19 test kit," saying its home sample collection methods follow recommendations from the state department of health and the Centers for Disease Control and Prevention.
“Tilt your head back slightly and insert the swab into one of your nostrils, aiming back (not upward) towards your ear, until you meet resistance,” the company wrote in a step-by-step guide for avoiding contamination of the swab and its container. “Gently rotate the swab in place for 5-10 seconds. (This may make you sneeze and/or cause your to eyes water [sic] which is normal and means you’ve done it correctly.)”
“YOU DID IT! Now take a moment to kick back, relax and take a little extra care of yourself. Listen to a your favorite playlist [sic], workout at home or catch a few episodes of your favorite Netflix series. You deserve it!”
Editor's note: This story has been updated with comment from Everlywell.