At-Home Collection for COVID-19 Testing

Exact Sciences Laboratories has expanded access to COVID-19 testing by offering a convenient and reliable at-home self-collection kit from Everlywell, an innovative at-home health testing company.

If you are an employer or organization that needs high-quality COVID-19 testing with the convenience and flexibility of at-home self-collection, we are here to help.

Here are the options to get started:

  • Option 1 - Are you an employer or organization that needs an at-home, self-collection solution?

    Select this option if you are an employer or organization that would like to request an at-home, self-collection solution or call our Customer Care Center at 1-844-870-8870 for more information.

    Fill out a Request Form

  • Option 2 - Already have an access code?

    Select this option if your employer or organization has already provided you with an access code to obtain an at-home collection kit.

    You will be taken to the Everlywell site where you will be asked to input your access code to initiate the process to receive your kit.

    Request a Kit

About Our COVID-19 Testing

Exact Sciences Laboratories tests upper respiratory samples for COVID-19 using PCR technology, which detects the virus that causes the disease. Results are used to determine whether someone has an active infection.

The Exact Sciences SARS-CoV-2 test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About the At-Home Collection Process

COVID-19 Test Home Collection Kits from Everlywell contain the supplies needed and simple instructions for at-home nasal swab collection.

Once a test taker receives a kit, follow the steps below to start the collection process:

  1. Test taker should go to ExactSciences.Everlywell.com to complete online screening and register their unique kit ID.
  2. The test taker will collect a nasal swab specimen from the supplied kit and return their completed kit to a designated overnight shipping carrier drop off location on the same day of sample collection.
  3. Kits will be shipped to Exact Sciences Laboratory for testing.
  4. Everlywell will send results to patients with a turnaround target of 72 hours from sample receipt at Exact Sciences Laboratories.
  5. A telehealth consult will be provided for all patients with a positive test result.

This home collection kit has not been FDA cleared or approved. This home collection kit has been authorized by FDA under an EUA. This home collection kit has been authorized only for the home collection and maintenance of nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This home collection kit in combination with the authorized test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Frequently Asked Questions

What type of COVID-19 testing does Exact Sciences Laboratories (ESL) offer?

Exact Sciences Laboratories tests for COVID-19 in upper respiratory samples by using a technology called PCR. The test detects the unique genetic sequences that are only found in the virus that causes COVID-19. Results are used to determine whether someone has an active COVID-19 infection.

Does Exact Sciences Laboratories offer antibody testing for COVID-19?

No. Exact Sciences does not offer antibody testing for COVID-19.

Has the Exact Sciences Laboratories test been granted Emergency Use Authorization by FDA?

Yes, the Exact Sciences SARS-CoV-2 test was authorized on Aug. 3, 2020.

The Exact Sciences SARS-CoV-2 test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories.

This test has been authorized only for the detection of nucleic acid from SARS- CoV-2, not for any other viruses or pathogens.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

How well does the test work?

Studies showed that the COVID-19 test from Exact Sciences Laboratories had 100% agreement with both positive and negative results from another FDA-authorized COVID-19 test. The ESL test did not detect other respiratory viruses or bacteria. The ESL test showed reliable detection of the SARS-CoV-2 virus, even when the virus was present at low levels.

Reference:

FDA. Emergency Use Authorization SARS-CoV-2 (N gene detection) Test (Exact Sciences Laboratory). https://www.fda.gov/media/138328/download. Accessed September 16, 2020.

How does the Exact Sciences Laboratories and Everlywell relationship work?

Exact Sciences Laboratories is working with Everlywell to offer a convenient and flexible at-home collection solution for COVID-19 testing. Everlywell provides online services for COVID-19 ordering, order tracking, results delivery, and for qualified physician access. Everlywell also provides an at-home nasal swab kit for specimen collection.

Has the Everlywell COVID-19 Test Home Collection Kit been granted Emergency Use Authorization by FDA?

Yes.

This home collection kit has not been FDA cleared or approved. This home collection kit has been authorized by FDA under an EUA.

This home collection kit has been authorized only for the home collection and maintenance of nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

This home collection kit in combination with the authorized test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

How long does it take to receive results?

Everlywell will send results to patients with a turnaround target of 72 hours from sample receipt at Exact Sciences Laboratories.

Who can order the at-home collection solution offered by Exact Sciences Laboratories?

Exact Sciences Laboratories is offering this solution to employers and organizations with a population of test takers who would benefit from the convenience and flexibility of at-home collection for COVID-19 testing.

How can an employer or organization request this service?

Please complete the Request COVID-19 At-Home Test Collection form or call our Customer Care Center at 1-844-870-8870 (follow the prompts for COVID-19 testing) to request our at-home collection solution. A representative will reach out to discuss your testing needs.

Is this testing available to the general public?

We cannot offer this solution to the general public at this time. This solution is only available to contracted entities.

My employer/organization has made this testing available to me. How do I get a kit?

Each employer/organization has a specific method to get kits to its employees/members. Please reach out to your employer/organization representative to get details on the process for requesting a kit.

Our state of the art contact center can assist you and answer your questions. Call 1-844-870-8870

You are now leaving Exactlabs.com

Exact Sciences Laboratories is committed to helping people access at-home collection for COVID-19 by offering COVID-19 Test Home Collection Kits from Everlywell.

Links to all outside sites do not imply a recommendation of a particular provider by Exact Sciences, nor an endorsement of our COVID-19 testing by other telehealth providers. Exact Sciences accepts no responsibility or liability for the content or services of other websites. All lab test ordering decisions are made by the healthcare provider, based on the patient’s needs.

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