US company launches first COVID-19 home test kit

EverlyWell, a digital health company specializing in at-home test kits, has come up with a solution to alleviate the ongoing problem concerning the COVID-19 pandemic.

The Texas-based company will offer consumers home test kits with telehealth diagnosis for COVID-19 beginning Monday, March 23.

Shortage of COVID-19 test kits spurs action from the FDA

With things getting critical every passing second, the coronavirus death rate in the U.S. is increasing at an alarming rate. As of this writing, the latest statistics show that there are over 32,783 cases, 416 deaths, and only 178 recoveries.

Currently, the COVID-19 testing kits are not easily accessible and testing takes way too much time.

The scarcity of test kits and the growing number of undetected cases in the U.S. prompted the Food and Drug Administration (FDA) to issue a new policy to expedite the availability of COVID-19 diagnostic tests in the States. The expanded policy allows any qualified laboratories to develop their own testing kits.

FDA Commissioner Stephen M. Hahn said in a statement:

“We believe this policy strikes the right balance during this public health emergency [. . .] This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation.”

Hahn further clarified that, following this policy expansion, the FDA is not changing its standards for issuing Emergency Use Authorizations.

“We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S,” he added.

EverlyWell takes up the challenge

EverlyWell was one of the first private laboratories to respond to the call. On March 9, the company announced a US$1 million [AU$1.7 million] incentive program to “certified laboratories who fulfilled requirements set by the FDA” and aid in the development of a home-collection test for COVID-19.

The “overwhelming” positive response from the laboratory community enabled EverlyWell to develop a solution in 10 days’ time.

“EverlyWell is uniquely positioned to step up and help in this crisis. We’ve built the infrastructure. We’re in this fight together,” EverlyWell CEO Julia Cheek said.

The company announced that an initial supply of around 30,000 test kits will be made available to the public on March 23, and that that they are working with different labs to scale its network. Cheek also added that they will “ramp to 250,000 test kits weekly.”

EverlyWell in talks with government to make home test kits free

Currently, the home test kits are made available at $135, “with no profit to the company.”

EverlyWell is in contact with government officials and public health departments to “explore possibilities” of providing the home test kits to consumers for free.

Cheek emphasized that the company’s key focus is to help people in this critical time:

“Everlywell was founded to give people affordable, convenient access to lab testing. Never has our mission been more important [. . . ] Our team has been working around the clock with top scientists and laboratories in the nation to develop a test that we will make available at the lowest price possible while covering our costs, at no profit to the company.”

Getting COVID-19 testing to your doorstep

Those who are experiencing the symptoms of COVID-19 can make an online request through the company’s website. Their samples would then be collected at home to help the patient stay away from any kind of exposure.

EverlyWell, however, highlights that a doctor still needs to prescribe the test in accordance with the FDA’s and CDC’s policies. Here is how one could get tested for COVID-19 at home:

  • Patients will answer a questionnaire from PWNHealth, a network of physicians who prescribe diagnostic tests.
  • Telemedicine doctors then review the answers and determine if a patient qualifies for testing.
  • If a test is prescribed, EverlyWell will send the test kit in two days, with an additional charge of $30 for overnight shipping.
  • The test comes with instructions and the necessary materials to collect nasoparyngeal swabs. Patients can also provide spit and sputum samples as backups.
  • After the collection of samples, they will be transferred to partner labs with overnight delivery. The results of the test would be available online after 48 hours.
  • The telehealth consultants would then provide further services for special cases that would test positive for COVID-19.

Positive results will also be subsequently communicated to all mandated federal and state reporting agencies.

As the pandemic continues to plague the whole world, everyone is advised to remain calm and observe proper precautions to curb the spread of the virus, including handwashing, social distancing, and self-quarantine.

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