Learn why Cancerguard™ is right for your patients

What is the intended use population? 

The Cancerguard test is intended for adults of either sex, ages 50-84 years who have had no known cancer diagnosis within the preceding 3 years.

The test is not indicated for screening of breast cancer, prostate cancer, or pre-cancerous lesions.

It is important to use your clinical discretion when identifying the right patients for testing.

Who is not an appropriate patient for the Cancerguard test?

The Cancerguard test is not intended for adults with a history of cancer or hematological malignancy in the last three years.

Given the potential for follow-up imaging (radiology) scans for positive results and the potential need for a CT with iodine-based IV contrast, patients with a history of adverse reactions to iodine-based IV contrast may not be appropriate candidates for this testing.

Consideration should be given to women who are, could be, or may become pregnant as a positive Cancerguard test may be followed up by imaging scans that may use ionizing radiation.

It is important to use your clinical discretion when identifying the right patients for testing.

What types of cancer does the Cancerguard test detect?

Results of a test development study showed that the Cancerguard test can find signals from many solid tumor types and some blood cancers. There were 21 types of cancers included in the study: lung, breast, colorectal, prostate, uterus, pancreas, head and neck, kidney, stomach, bladder, esophagus, liver, anus, ovary, cervix, thyroid, vulva, small intestine, testis, Non-Hodgkin’s Lymphoma, and multiple myeloma.1 The Cancerguard test was able to find signals for 20 of the 21 types of cancer. It did not detect one case of multiple myeloma included in the study.

While these are the 21 types of cancers included in the study, the Cancerguard test may potentially detect a cancer signal from cancers not specifically evaluated or validated during development.

The Cancerguard test is not indicated for screening of breast and prostate cancer. This test is not a replacement for existing recommended cancer screening or diagnostic modalities for cancer.

How do I order the test for my patient? 

Orders for the Cancerguard test may be placed either via a paper Test Requisition Form, online portal (EpicCare Link or Exact Sciences Provider Hub), or through your electronic medical record system. Ordering options may vary by clinic/health system. If you have additional questions about the test ordering process, please contact the Customer Care Center at 844-870-8870.

How do I cancel a Cancerguard test?

Prior to blood specimen collection and kit shipment, a Cancerguard test order can be cancelled by contacting the Customer Care Center at 844-870-8870. Once the patient’s blood sample has been collected and shipped to Exact Sciences Laboratories, the test will be considered in process and cancellation cannot be guaranteed.

What is needed to collect specimens for the Cancerguard test?

The Cancerguard test requires an Exact Sciences Blood Specimen Kit labeled with Cancerguard™ for collection and transport of blood specimens to the performing laboratory.

The kit contains the appropriate blood collection tubes and packing materials needed for specimen collection and shipment.

Each kit is a single unit. Tubes from other kits should not be used.

To order blood specimen kits for your office, please contact our Customer Care Canter at 844-870-8870.

Should the kits and tubes be stored in the refrigerator or freezer?

No. The blood specimen kits and tubes must be stored at room temperature (15-25 °C, or 59-77°F). Please do not store the blood specimen kit or tubes in the refrigerator or freezer.

Improper storage conditions, such as exposure to temperatures outside the recommended range may compromise specimen integrity and could possibly lead to inaccurate or invalid test results.

After collection, ship specimens in the blood specimen kit, which includes two temperature-control gel packs to maintain the appropriate temperature.

How quickly do the kits expire?

The kits are designed to have a shelf life of up to 12 months, but expiration dates may vary. You may receive kits with less than 12 months prior to expiration.

Always check the expiration date labels on each kit before proceeding with specimen collection and discard any expired kits.

What sample types are used for the Cancerguard test?

The Cancerguard test uses blood from specimens collected in LBgard^® Blood Tubes, which are included in the blood specimen kit.

We do not accept blood collected in any other tubes or any other sample types.

How much blood is required to do the testing?

To ensure that enough blood is available to complete the Cancerguard test, four (4) LBgard^® Blood Tubes must be collected.

Each LBgard Blood Tube should be completely filled with 8.5 ml of blood per tube (total 34 ml).

Please fill each LBgard Blood Tube to the black line marked on the label or until the vacuum has been exhausted.

It is important to prioritize filling tubes completely to the black line marked on the label or until the vacuum has been exhausted. Do not underfill multiple blood tubes to draw some blood in all 4 tubes.

Do I need to fill the tubes in a particular order?

If you are collecting blood only for the Cancerguard test, tubes do not need to be drawn in any specific order.

If you are collecting blood for the Cancerguard test in addition to other tests (CBC, BMP, Lipid Panel, etc.), the LBgard^® Blood Tubes should be filled after EDTA tubes and before glycolytic inhibitor tubes. If a heparin tube precedes LBgard tubes in the draw order, it is recommended that a non-additive or EDTA tube be drawn as a waste tube before collecting in LBgard tubes. Please refer to the LBgard^® Blood Tubes Instructions for Use for additional information.

Should blood be drawn on a particular day of the week?

Yes. Since the blood specimen must be processed within 72 hours at Exact Sciences Laboratories, patients should have their blood drawn for the Cancerguard test Monday through Friday only.

For Friday collections, check with FedEx to find out the last pickup time in your area prior to collecting. Ensure blood is collected prior to the last pickup time.

Please ship kits to the laboratory the same day specimens are collected using FedEx Priority Overnight delivery.

Do not collect and ship specimens on weekends and on observed holidays.

Does the Cancerguard test require a fasting blood specimen?

No. Patients are not required to fast before blood collection for the Cancerguard test.

Where can patients get their blood drawn?

Patients should have their blood drawn at a laboratory/phlebotomy location associated with your clinic or healthcare system. If a redraw is needed, alternative blood collection solutions may be available.

When can I ship specimens to the laboratory?

Since blood specimens must be processed within 72 hours of the blood draw, they should be shipped to the laboratory on the same day as collected, Monday through Friday, and not on holidays.

For Friday collections, check with FedEx to find out the last pickup time in your area prior to collecting.

The laboratory can receive specimens for the Cancerguard test Monday through Saturday.

The laboratory cannot receive specimens on Sundays or holidays.

Is an additional ice pack or dry ice needed to ship the tubes after collection?

No. The Exact Sciences Blood Specimen Kit labeled with Cancerguard includes two temperature-control gel packs.

Do not remove these gel packs from the kit.

Do not use any other ice packs or dry ice for shipping specimens to the laboratory.

Will the specimens be okay to ship during extreme weather?

Extreme weather is not expected to impact the stability of the blood specimens. However, weather events may delay shipping. The blood specimen must be processed within 72 hours of the blood draw.

What happens if the specimen cannot be processed or a valid result is not obtained?

If the specimen cannot be processed or a valid result is not obtained, you will be notified by Exact Sciences Laboratories with information about next steps. Your patient will have the option to have their blood re-collected.

What results does the Cancerguard test provide? 

The Cancerguard test generates positive (cancer signal detected) or negative (no cancer signal detected) results.

In some instances, QC failure or insufficient clinical material may lead to an invalid test. In the case of an invalid test, new blood specimens will need to be collected to re-initiate the testing process.

Can I receive the individual biomarker results?

No. The individual biomarker results will not be made available.

If you have further questions about this information, consultations with our laboratory directors are available. Please contact our Customer Care Center at 844-870-8870 to connect with a laboratory director.

How do I receive test results?

Results will be sent directly to you based on your ordering method:

• Paper Test Requisition Form: Results sent via secure fax to the number provided.
• EpicCare Link: Results available via EpicCare Link I
• Exact Sciences Provider Hub (ESPH): Results available via ESPH
• Electronic Medical Record (EMR): Results returned via your EMR system

What is the expected turnaround time to receive results?

The expected average turnaround time to receive results is within two weeks upon laboratory receipt of patient specimens.

Will I receive results before the patient?

Depending on communication channels available with a patient, they may receive their Cancerguard test results at the same time the results are released to you. Regardless of when and how results are made available by Exact to patients, the intent is that the patient's healthcare provider discusses the results with them.

What does a positive Cancerguard test result mean?

A positive Cancerguard test result means the blood test identified a signal that may indicate the presence of cancer.

A positive Cancerguard test result alone does not confirm the presence of any cancer. False positive results can occur.

Follow-up clinical evaluation by a healthcare provider including routine labs followed by imaging are needed to locate and confirm a diagnosis of cancer or determine that cancer is not present.

What are the next steps following a positive Cancerguard test result?

A positive test result alone does not confirm the presence of any cancer. False positive results can occur. Further clinical evaluation and follow-up imaging are needed to locate and confirm a diagnosis of cancer or determine whether the cancer is not present.

There are no established national guidelines for imaging following a positive Cancerguard test result. Exact Sciences has developed a proposed clinical algorithm for imaging-based diagnostic resolution following a Cancerguard test based on published expert clinician opinion and results from an exploratory, prospective, interventional study. To request this resource, contact your regional Medical Science Liaison, the Medical Information team or the Care Navigation Team.

Briefly, in the absence of a clear suspicion of cancer, based on symptoms, other testing, and/or medical history that points to targeted imaging, follow-up imaging may include CT with IV contrast of the neck (soft tissue), chest, and abdomen/pelvis.2

If results of the CT imaging are negative for cancer or any result as “indeterminate” patients may need follow-up with traditional whole-body head-to-thigh 18F-FDG PET-CT scan.2,6

Additional imaging or diagnostic testing may be recommended at the discretion of the ordering provider, based on a patient’s clinical presentation.

What are the CPT codes for the imaging scans mentioned?

Common CPT codes for the imaging scans in the proposed imaging-based diagnostic resolution pathway:

CT with IV Contrast-Soft Tissue Neck: 70491

CT with IV Contrast-Chest: 71260

CT with IV Contrast-Abdomen/Pelvis: 74177

PET-CT: (Skull to Thigh with 18-FDG): 78815

These codes listed are provided for informational purposes only and are not intended to be an all-inclusive list, nor do they constitute reimbursement or legal advice. Ordering providers are responsible for determining follow-up testing and imaging based on their clinical assessment of the patient, and for submitting accurate and appropriate claims for services. Payer policies will vary and should be verified prior to treatment for limitations on diagnosis, coding, or site of service requirements.

What does a negative Cancerguard test result mean?

A negative Cancerguard test result means that the test did not identify a cancer signal. A negative result does not rule out the presence of cancer of any type. False negative results can occur.

Results should be interpreted in the context of a patient’s medical history, clinical signs, and symptoms.4

What are the next steps for a negative result?

The Cancerguard test is not a replacement for existing recommended cancer screening or diagnostic tests. Current recommended screening for cancer should also be followed.

The Cancerguard test may be offered to patients as part of their routine care.

When someone gets a Cancerguard test, why do they also need to continue with routine cancer screening tests?

The Cancerguard test is designed to complement recommended routine screening. It is not intended to replace these important single-cancer screening tests.

In the DETECT-A study, the use of a multi-cancer early detection test along with recommended routine screening was shown to double the number of cancers first detected through screening.5

What happens if the follow-up imaging scans come back negative after a positive Cancerguard test result?

If follow-up imaging scans do not identify a potential cancer, it may mean the Cancerguard test produced a false positive.

Current recommended screening for cancer should be followed. Repeat Cancerguard test may be offered to patients as part of their routine care.

How frequently should patients get Cancerguard testing?

At this time, there are no published guidelines regarding the test interval for Cancerguard or other MCED tests. Patients should follow guideline-recommended screening options and consult with their healthcare provider to determine if and how often to perform the Cancerguard test.

Is the Cancerguard test covered by health insurance?

Most insurance plans cover eligible patients including Medicare and commercial insurance. Out-of-pocket (OOP) costs for the test, if any, are determined by the patient’s insurance company. They may have co-pay, co-insurance, deductible, or non-covered charges as determined by the individual’s plan.

How much does the Cancerguard test cost?

The self-pay price of the Cancerguard test is $689. The test may be HSA/FSA eligible. Patients should check with their HSA/FSA administrator to determine eligibility. Pricing is subject to change by Exact Sciences at any time.

Is there any support available to help a provider navigate next steps if a patient receives a positive Cancerguard test result?

Yes. Exact Sciences has Care Navigation guidance and education to help streamline next steps after a patient has a positive Cancerguard test result. To connect with the Care Navigation team please call 844-870-8870 or email patientnavigation@exactsciences.com.

Imaging Reimbursement

• Ready-to-use workflows to help care team manage next steps for diagnostic resolution following a Cancerguard test
• Education with information and guidance on follow-up imaging
• Access to Exact Sciences Medical Sciences Liaisons (MSLs) and laboratory medical directors for additional clinical guidance and support

Will insurance cover the cost of the follow-up imaging scans?

Coverage may vary based on insurance plans and each patient’s unique situation. If a patient needs help covering the cost of follow-up imaging, Exact Sciences offers an Imaging Reimbursement Program. The program reimburses up to $6,000 for non-covered imaging costs to help reduce the financial impact for eligible patients. Please note that patients must apply. Eligibility depends on program qualifications and is not guaranteed. The program will not reimburse any covered imaging costs, including copay, coinsurance and/or deductible amounts determined by insurance. For more information, patients should call 844-870-8870.