Startup Hims & Hers announced Wednesday it's now offering FDA-authorized COVID-19 testing kits to order online and administer at home.
Men's health startup Vault Health also recently started selling at-home saliva test kits, which rely on a sample of spit in a test tube.
Both companies are distributing a saliva test developed by Rutgers University laboratory, called RUCDR Infinite Biologics, in partnership with Spectrum Solutions and Accurate Diagnostic Labs, which was granted emergency use authorization by the U.S. Food and Drug Administration (FDA) just last week.
Until last week, at-home testing had been prohibited by regulators. The move by the FDA opened up distribution for at-home saliva tests to patients by way of mail.
“We’ve been committed since day one to provide convenient and affordable access to healthcare,” said Hims & Hers founder and CEO Andrew Dudum in a blog post. “We know that people have questions about COVID-19, including possible symptoms and how to get tested if they are concerned about their health. At Hims & Hers, we want to serve as a resource, offering access to results as quickly as possible and bringing relief and answers to as many Americans as we can.”
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Customers will be able to view their results through the Hims & Hers platform, and a medical provider will be in touch with recommended next steps depending on the results, the company said.
Hims & Hers will be offering the tests at cost for $150—$80 goes to the lab to cover the cost of creating and processing the kits; $20 will go to the medical providers for consultations and testing and $50 will cover the cost of expedited shipping.
New York City-based Vault Health said in a press release that it will make thousands of tests available every week and will continue to scale test availability as the capacity of RUCDR Infinite Biologics quickly expands.
"With our team of practitioners, we have the capacity to manage 10,000 tests per day and are building to scale. People experiencing COVID-like symptoms need to know if they can safely return to work. We will help them find the answer fast," said Vault Health CEO Jason Feldman.
One of Vault's main goals with the at-home saliva test is to work with businesses in order to allow their employees to get back to work.
For the test provided by Vault Health, the saliva collection test is performed under the supervision of a Vault healthcare provider through a video telehealth visit, according to the company. Test results are available in two to three days.
Vault's lab test also costs $150, which covers the cost for telemedicine, operations, overnight shipping, the test kit and lab processing.
Health startup LetsGetChecked also is working to develop an at-home COVID-19 test.
To date, 9.6 million people in the U.S. have been tested for the coronavirus, according to the COVID Tracking Project. But public health experts like Anthony Fauci, M.D., the nation’s leading infectious disease expert, said testing needs to double by the end of May.
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The FDA said Rutgers submitted data showing that testing saliva samples collected by patients themselves, under the observation of a healthcare provider, was as accurate as testing deep nasal swabs that the health professional had collected from them.
Home testing for COVID-19 has the potential to significantly expand the volume of people who can get tested as some states work to reopen and also helps protect healthcare workers from potential exposure to the virus.
There are limitations to saliva tests. The FDA notes that the collection of saliva specimens is limited to patients with symptoms and that negative results should be confirmed by testing an alternative specimen. Saliva tests also may not be able to detect the virus in asymptomatic people.
Some healthcare experts are concerned about the reliability of home testing, especially given the potential for contamination or disturbance when the samples are shipped.