A collection of home telehealth and testing startups have begun offering COVID-19 testing kits directly to consumers amid a lag in testing.
At-home health testing company Everlywell will begin selling COVID-19 testing kits to consumers on March 23.
Austin, Texas-based Everlywell offers more than 30 at-home lab testing kits for food sensitivity, fertility, STDs, thyroid function, metabolism, vitamin D and inflammation. Given the extreme shortage of tests, the company added COVID-19 testing to its at-home collection kits to help diagnose more cases.
The initial supply of 30,000 tests amounts to a significant increase in total COVID-19 tests that have been processed in the U.S. as of March 18, the company said on its website.
By working with multiple labs to scale infrastructure, Everlywell plans to have testing and diagnosis capacity for a quarter of a million people weekly.
All of Everlywell's laboratory partners conducting COVID-19 testing are complying with FDA's Emergency Use Authorization for COVID-19 testing.
The test will be available for $135 at no profit to Everlywell, and will be covered by participating HSA and FSA providers.
Meanwhile, women’s and sexual health-focused telehealth startup Nurx said it is developing its own mail-in coronavirus test in partnership with service provider Molecular Testing Labs.
"Allowing people to take a COVID-19 test remotely can be a valuable strategy for containing the virus because it decreases the risk of exposure for both patients and in-person healthcare providers, while also decreasing the strain on brick-and-mortar healthcare services," the company said in a blog post.
Nurx said it will focus its testing efforts on people who have had direct exposure to COVID-19 and/or those who are experiencing symptoms.
Los Angeles-based Scanwell Health is providing what it calls the first clinical-grade at-home test for COVID-19 can be done in 15 minutes.
The company, which develops smartphone-enabled, at-home diagnostics, is still waiting to obtain Emergency Use Authorization (EUA) from the FDA for at-home use of serology tests. The SARS-CoV-2 rapid test kits will be available within 6 to 8 weeks, according to the company, and will first roll out in Washington, California, New York and other severely affected states.
The technology was developed by Chinese diagnostic technology company INNOVITA and has already been approved by China’s equivalent of the FDA and used by “millions” in China, the company said. The test can be taken at home in 15 minutes with the guidance of a medical professional via telehealth and produces results in just hours.
Telehealth startup Lemonaid Health is partnering with Scanwell Health to provide doctors and nurse practitioners to perform the initial intake questionnaire with patients and order the test, following guidelines established by the Centers for Disease Control and Prevention (CDC).
New York City-based startup Radish Health also announced this week that it is launching an FDA-approved at-home COVID-19 test kit for NYC client partners.
The company works with employers to offer an on-demand, onsite healthcare service for employees, whether in its clinics, at employees' worksites, or through a virtual platform.
After a short test period, Radish plans to make the COVID-19 test kit available to all New Yorkers at a cost of $100, plus the cost of the lab which will be covered by insurance, the company said on its website.
While the Trump administration has promised a mass rollout of tests, supply in the U.S has lagged behind that in other countries. From mid-January until Feb. 28, fewer than 4,000 tests from the U.S. Centers for Disease Control and Prevention were used out of more 160,000 produced, according to the Washington Post.
After weeks of stalled testing, on Feb. 29, the Food and Drug Administration (FDA) issued a new policy to expedite the process for some laboratories to develop new diagnostic tests for SARS-CoV2, which allowed hundreds of labs to test for the virus.
Delays in testing in the United States have set back the nation’s response to the pandemic.
As of March 19, the CDC reported that 44,872 specimens have been tested—about 4,500 at CDC labs and 40,400 at public health labs. There are currently 89 public labs offering testing, the CDC said.
According to the COVID Tracking Project, a voluntary internet community effort to track testing, at least 111,638 people have been tested in the United States, much higher than official CDC figures.
That tracker collects information directly from state health departments, local news reports, and live news conferences.
The CDC reports there are 10,442 confirmed coronavirus cases in the U.S. while Johns Hopkins University's coronavirus resource center reports there are 14,250 U.S. cases.
Federal officials said Monday they were moving ahead with plans to set up more drive-through testing centers around the country and to speed the processing of tests by commercial labs. By the end of the week, officials said that 1.9 million tests should be available, the New York Times reported.