COVID-19 Testing

Exact Sciences is committed to responding to the challenges posed by coronavirus (COVID-19), while continuing the fight against cancer. In collaboration with state authorities and health officials, we’re utilizing our laboratory capabilities and infrastructure to support COVID-19 testing efforts. We are also pleased to be working with Everlywell to offer a Home Collection Kit for COVID-19 testing. The information on this page is specific to Exact Sciences' COVID-19 testing offered through healthcare providers. To learn more about our at-home test collection solution through Everlywell, please go here

The COVID-19 test is offered through US physicians and authorized healthcare providers. The test is intended for use with patients who meet the CDC’s current guidance for evaluation of COVID-19 infection.

We look forward to applying the lessons we’ve learned in the ongoing fight against cancer to help bring an end to this public health crisis. If you have questions or would like more information on Exact Sciences’ COVID-19 test, please reach out to our support team at 844-870-8870.

Information for Ordering Providers

Exact Sciences Laboratories utilizes real-time RT-PCR testing to detect RNA from SARS-CoV-2, the virus which causes COVID-19. Testing is performed on respiratory specimens to determine whether active infection is present.

The Exact Sciences Laboratories 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.

Healthcare Provider Services

Exact Sciences COVID-19 testing is available through healthcare providers who have an established account with our company. Individuals who are interested in COVID-19 testing should contact their healthcare provider or follow local health department announcements for testing locations.

Wisconsin providers and healthcare organizations should visit the state website (https://covid19supplies.wi.gov/Testing) to set up ordering and to request testing supplies, if needed. Further information about our test can be found in the COVID-19 Customer Guide Outline in the Additional Resources section.

For non-Wisconsin providers and healthcare organizations, please call our Exact Sciences Customer Care Center at 844-870-8870 for assistance.

Testing Process

Highlights of the testing process are summarized in this section, while detailed test information is provided in the Additional Resources section.

1. Sample Collection

The following specimen types are accepted by Exact Sciences Laboratories for SARS-CoV-2 testing.

  1. Nasopharyngeal (NP)
  2. Nasal (Anterior Nasal)
  3. Oropharyngeal (OP)
  4. Mid-turbinate

In accordance with FDA and CDC recommendations, our lab accepts samples collected using synthetic-tipped swabs on either plastic or aluminum shafts. Please avoid swabs with cotton tips, wood shafts, or calcium alginate preservatives. The following types of transport media may be used: viral transport media (VTM), universal transport media (UTM), Amies, and RNAse-free saline.

Exact Sciences Collection Supplies: For those who request them, our lab can provide collection supplies which include a synthetic-tipped swab on a plastic shaft and RNAse-free normal saline transport media. If you choose to use supplies from Exact Sciences Laboratories, they may be used for nasal (anterior nares) collection. For convenience, nasal collection instructions are provided with Exact Sciences Laboratories supplies. The video below will guide you through the nasal collection and handling process.

 

2. Specimen Handling and Shipping to Exact Sciences Laboratories

To ensure the best possible testing results, Exact Sciences Laboratories specifies several necessary components for every specimen. Specimens need to have appropriate patient identification to allow our lab to properly report test results. Specimens need to have accurate collection information and need to be handled properly to ensure that they are in an appropriate condition for testing. Specific specimen requirements are listed below:

Specimen Acceptance Criteria:

  • Patient Identification Elements
    • First name of patient
    • Last name of patient
    • Date of birth for patient

*Specimens will only be accepted if these identifiers are clearly evident on the collection device/tube or on the order documentation--the order form or the electronic information provided via interface

  • Collection Elements
    • Date of specimen collection
    • Time of specimen collection

*If the time of collection is not provided, the lab will default to 12:00am on the date of collection for stability determination

  • Specimen Transport Elements
    • Specimens must arrive chilled—on ice packs, cold packs, or refrigerated at 2-8⁰C
    • Chilled specimens must arrive within 72 hrs of collection
    • Specimens that will arrive after 72 hours of collection, will be accepted if they were frozen at ≤ -70⁰C immediately after collection and shipped with plenty of dry ice--much colder than a residential freezer
    • Collection tubes should be intact, not leaking, and without gross contamination

Specimen Delivery Instructions

  • Deliver to 650 Forward Dr. Madison, WI 53711
  • Hand deliveries should arrive at Dock S12 and ring the bell to be greeted by the laboratory sample receipt staff
  • Semi-trucks can use Dock S14 
3. Results Delivery

The COVID-19 test results are released to the ordering provider using secure electronic methods. Most providers utilize our secure online portal, called EpicCare Link, which may be used even if a provider does not use Epic for their medical record system. An EpicCare Link User Guide can be found in the Additional Resources section.

For healthcare organizations with the IT capability, our team can explore other options for ordering and results delivery.

The ordering provider will be called for all positive results, unless this option is declined by the provider.

Results will be reported to state health departments in accordance with communicable disease reporting requirements.

After results have been released to the ordering provider, patients will be invited to view their results through the secure Exact Sciences MyChart patient portal.

How to Contact Us

Call our Customer Care Center at 844-870-8870, and follow the prompts for COVID-19 testing.

Frequently Asked Questions

What type of COVID-19 test does Exact Sciences offer?

Real-time RT-PCR for the detection of the SARS-CoV-2 virus, which causes COVID-19.

How well does your test work?

Validation studies showed that the Exact Sciences Laboratories test had 100% agreement with both positive and negative results from another COVID-19 test with FDA Emergency Use Authorization. (clinical evaluation) The Exact Sciences Laboratories test did not cross-react when performed on a panel of other respiratory pathogens. (specificity) The Exact Sciences Laboratories test showed reliable detection of SARS-CoV-2 at 1.2 genomic copies per microliter of specimen (analytical sensitivity). Please note that these are lab-based studies, and clinical correlation with the presence of COVID-19 has not been established.

References:

FDA. Emergency Use Authorization SARS-CoV-2 (N gene detection) Test (Exact Sciences Laboratory). https://www.fda.gov/media/138328/download. Accessed August 6, 2020.

What types of specimens do you accept?

The supplies that Exact Sciences Laboratories distributes can be used for nasal (anterior nares) specimens. However, our lab accepts upper respiratory specimens (e.g. nasopharyngeal, oropharyngeal, mid-turbinate and nasal) in VTM, UTM, saline or other CDC recommended transport media. These recommendations can be found at the following links.

Why is it so important to fill out all the information on the order requisition form?

Certain information is essential for our lab to properly identify specimens and to ensure that specimens are in the appropriate condition for testing. Our criteria for accepting specimens are listed below.

  • Patient Identification Elements
    • First name of patient
    • Last name of patient
    • Date of birth for patient

*Specimens will only be accepted if these identifiers are clearly evident on the collection device/tube or on the order documentation--the order form or the electronic information provided via interface

  • Collection Elements
    • Date of specimen collection
    • Time of specimen collection

*If the time of collection is not provided, the lab will default to 12:00am on the date of collection for stability determination

  • Specimen Transport Elements
    • Specimens must arrive chilled—on ice packs, cold packs, or refrigerated at 2-8⁰C
    • Chilled specimens must arrive within 72 hrs of collection
    • Specimens that will arrive after 72 hours of collection, will be accepted if they were frozen at ≤ -70⁰C immediately after collection and shipped with plenty of dry ice--much colder than a residential freezer
    • Collection tubes should be intact, not leaking, and without gross contamination
How should I store and ship the samples?

Samples should be chilled to 2-8⁰C, which can be done with a refrigerator or ice packs in a cooler. It is very important to ship the specimens to our lab as soon as possible, preferably sending the specimens the day of collection. Any specimens that do not arrive within 72 hours will have to be rejected, unless they were frozen at ultra-low temperatures (-70⁰C or lower) and sent with plenty of dry ice.

Where do I deliver the samples?
  • Deliver to 650 Forward Dr. Madison, WI 53711
  • Hand deliveries should arrive at Dock S12 and ring the bell to be greeted by the laboratory sample receipt staff
  • Semi-trucks can use Dock S14
How do I order testing from Exact Sciences Laboratories?

Wisconsin providers and healthcare organizations should visit the state website (https://covid19supplies.wi.gov/Testing) to set up ordering and to request testing supplies, if needed. Further information about our test can be found in the COVID-19 Customer Guide Outline in the Additional Resources section.

For non-Wisconsin providers and healthcare organizations, please call our Exact Sciences Customer Care Center at 844-870-8870.

What are your ICD-10 codes, CPT codes, and LOINC codes?

Common diagnosis codes associated with COVID-19 are listed on the COVID-19 Customer Guide Outline linked in the Additional Resources section and on the Order Requisition Form. Please note that this information is not intended to replace the medical judgement of the ordering provider. The ordering provider is responsible for patient diagnosis. Ordering providers should report the diagnosis code(s) that best describes the reason for performing the test.

CPT Code: U0003

LOINC codes: 94533-7: (qualitative detection of N gene of SARS-CoV-2)

How long does it take to get results from Exact Sciences Laboratories?

From the time that our lab receives the specimen, please expect it to take 72 hours to deliver the result to the ordering provider. It is important to note that this time does not include specimen transport time to our lab.

The Exact Sciences Laboratories swabs look different from shipment to shipment. Are there any differences in performance or how they are used?

Specimen collection swabs distributed by Exact Sciences may vary in physical appearance from packet to packet. All provided swabs meet the recommendations from the FDA and CDC for COVID-19 testing, and Exact Sciences has performed analyses to ensure that the swabs function as expected with our tests. All swabs can be used to collect nasal samples per the nasal collection instructions provided. 

What do each of the possible results mean?
  • Positive: SARS-CoV-2 (COVID-19) RNA was detected.
  • Negative: SARS-CoV-2 (COVID-19) RNA was not detected. Negative results do not preclude COVID-19 infection and should not be used as the sole basis for treatment or other patient management decisions.
  • Invalid: A result was not able to be produced because either something prevented the assay from performing as expected or the specimen did not contain enough clinical material. Recollection is recommended if clinically indicated.
How much does your test cost?

The list price of our test is $209.

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