Answering your frequently asked questions

The Oncoguard^® Liver solution is an innovative offering to aid in the detection of hepatocellular carcinoma. Combining a blood test demonstrating high performance for the detection of early- and later-stage hepatocellular carcinoma with a patient engagement program aimed at helping patients follow through with routine surveillance, the Oncoguard^® Liver solution offers a streamlined approach to hepatocellular carcinoma surveillance and support to help patients at risk.

The Oncoguard^® Liver test is a simple, single blood test for the detection of biomarkers associated with hepatocellular carcinoma. The test uses a sophisticated algorithm that combines the analysis of methylated DNA markers (MDMs) and alpha-fetoprotein (AFP) with a patient’s biological sex to generate an easy-to-interpret qualitative result that can aid in the detection of hepatocellular carcinoma.

The Oncoguard^® Liver test is a blood-based test for the qualitative detection of biomarkers associated with hepatocellular carcinoma in serum and plasma derived from whole blood.

The test is intended as an aid in the detection of hepatocellular carcinoma for adults with liver cirrhosis and/or chronic hepatitis B (HBV) who are at risk for hepatocellular carcinoma. Biannual surveillance is recommended in patients at risk for hepatocellular carcinoma.^1,2

The Oncoguard^® Liver test was validated in patients at risk for hepatocellular carcinoma, including those with cirrhosis and/or chronic HBV.

Patients who are not currently recommended for hepatocellular carcinoma surveillance, such as those who are at average risk for hepatocellular carcinoma, are not the appropriate patients for testing with the Oncoguard^® Liver test.

The Oncoguard^® Liver test has not been validated in patients at risk for hepatocellular carcinoma who:

• Have Non-cirrhotic HCV, Non-cirrhotic NASH, Non-cirrhotic NAFLD
• Had hepatocellular carcinoma resected in the past
• Have transitioned gender using exogeneous hormone therapy

Patients who are or may be pregnant should not be tested with the Oncoguard^® Liver test.

According to the American Association for the Study of Liver Diseases, patients are considered eligible for hepatocellular carcinoma surveillance if they are believed to have:³

• Cirrhosis of any etiology
  • Hepatitis B, C
  • Alcohol
  • NAFLD
  • NASH
  • Genetic hemochromatosis
  • Stage 4 primary biliary cholangitis
  • Alpha-1-antitrypsin deficiency
  • Other cirrhosis
• Select chronic Hepatitis B carriers without cirrhosis

Currently, no. The assignment of male or female sex at birth is used to determine the Oncoguard^® Liver test result. We do not currently have data on the performance of the Oncoguard^® Liver test for patients assigned intersex at birth.

Yes. A patient on hormone therapy can still use the Oncoguard^® Liver test. We do not have data on the performance of the test in patients transitioning genders using hormone therapy. We will need to know the patient’s sex assigned at birth to determine their Oncoguard^® Liver test result.

• Sensitivity (true positive rate): The proportion of persons with disease who have a high test (high test results among persons with disease).
• False Negative Rate (1 minus sensitivity): The proportion of persons with disease who have a negative test (negative test results among persons with disease).
• Specificity (true negative rate): The proportion of persons without disease who have a negative test (negative test results among persons without disease).
• False Positive Rate (1 minus specificity): The proportion of persons without disease who have a high test (high test results among persons without disease).
• Positive Predictive Value: The proportion of persons with disease among those with a high test (disease present among those with high test results).
• Negative Predictive Value: The proportion of persons without disease among those with a negative test (disease absent among those with negative test results).

• The Oncoguard^® Liver test is 88% sensitive for identifying hepatocellular carcinoma.
• The Oncoguard^® Liver test is 82% sensitive for identifying early-stage hepatocellular carcinoma.
• The Oncoguard^® Liver test is 94% sensitive for identifying later stage hepatocellular carcinoma.

In the lab clinical validation study, the Oncoguard^® Liver test identified 88% of patients with cancer at any stage, which means that 12% with cancer at any stage, tested negative with the Oncoguard^® Liver test.

The Oncoguard^® Liver test specificity is 87%.

In the clinical lab validation study, the false positive rate of the Oncoguard^® Liver test was approximately 13%, which means a high result was returned although no presence of hepatocellular carcinoma was noted on imaging report.

The Oncoguard^® Liver test is intended as an aid in the detection of hepatocellular carcinoma for adults with liver cirrhosis and/or chronic hepatitis B who are at risk for hepatocellular carcinoma. Biannual surveillance is recommended in patients at risk for hepatocellular carcinoma.^1,2 The Oncoguard^® Liver test was designed to be highly sensitive, particularly in the detection of early-stage (BCLC stage 0, A) hepatocellular carcinoma, making it an innovative tool for use in biannual surveillance. The Oncoguard^® Liver test was not validated in a direct comparison to or in conjunction with ultrasound. As an independent diagnostic assay the Oncoguard^® Liver test achieved an 82% sensitivity for the identification of early-stage hepatocellular carcinoma, 94% for late-stage hepatocellular carcinoma with an overall sensitivity of 88%.⁵

This test was developed, and its performance characteristics determined, by Exact Sciences. It has not been cleared or approved by the US Food and Drug Administration (FDA). This test is used for clinical purposes. It should not be regarded as investigational or for research. The test is performed at Genomic Health, Inc. an Exact Sciences company which is certified under the Clinical Laboratory Improvement Amendments (CLIA) and qualified to perform high complexity clinical laboratory testing.

• The performance of the Oncoguard^® Liver test has been established in a cross-sectional case control study. Longitudinal performance of the Oncoguard^® Liver test (i.e., benefits and risks with repeated testing over an established period) has not been studied. Performance has not been evaluated in adults who have been previously tested with the Oncoguard^® Liver test. Non-inferiority or superiority of the Oncoguard^® Liver test for hepatocellular carcinoma detection as compared to ultrasound has not been established.
• Guidelines for hepatocellular carcinoma surveillance recommendations do not recommend testing in individuals at average risk for hepatocellular carcinoma or those with Child Pugh C liver status unless the patient is eligible for a liver transplant.² The decision to utilize the Oncoguard^® Liver test should be made on an individualized basis.
• A negative Oncoguard^® Liver test result does not guarantee absence of cancer. Patients with a negative Oncoguard^® Liver test result may be advised to continue participating in a hepatocellular carcinoma surveillance program with a method and interval suitable for the individual. For persons at risk for hepatocellular carcinoma, a 3- to 6-month surveillance interval is suggested by AASLD guidelines.^1,2
• The Oncoguard^® Liver test may produce false negative or false positive results. A false positive result occurs when the Oncoguard^® Liver test produces a high result, even though a contrast-enhanced CT or MRI will not find cancer. A false negative result occurs when the Oncoguard^® Liver test does not detect a cancer even when a contrast enhanced CT or MRI identifies the high result.
• Patients should not provide a sample for the Oncoguard^® Liver test if they are pregnant or believe they are pregnant. The Oncoguard^® Liver test includes a measurement of AFP, which may be elevated during pregnancy.⁴
• The Oncoguard^® Liver test results should be interpreted with caution in patients with congenital disorders of the reproductive system or patients undergoing gender reassignment exogeneous hormone therapy as the performance of the test has not been validated in this population.
• To ensure the integrity of the sample, the laboratory must receive the patient specimens within 5 days of collection. Providers should send specimens to the laboratory the same day specimens are collected, according to the instructions stated in the Oncoguard^® Liver test Specimen Collection Guide (OncoguardLiver.com/resources).

You can call 1-844-870-8870 to speak to a member of our Customer Care Center. They will put you in contact with one of our representatives to provide you with more information about the Oncoguard^® Liver solution and help you with account set-up.

Once you set up an account with Exact Sciences, we can get you supplies. Then, the Oncoguard^® Liver test can be ordered by fax with a requisition form or electronically through the EpicCare^® Link^TM portal. EpicCare^® Link^TM is a secure, online tool for healthcare professionals and support staff registered with Exact Sciences Laboratories. Log into EpicCareLink.ExactSciencesLabs.com to order a test or request access if you do not already have an account.

Yes. The Oncoguard^® Liver test requires the Exact Sciences Blood Collection Kit to transport the collected specimens to the performing laboratory. The Blood Collection Kit contains the appropriate tubes and packing materials needed for specimen collection and shipment.

Yes. The Blood Collection Kit contains one BD Vacutainer^® SST^TM tube and three LBgard^® Blood Tubes. The LBgard tubes contain a special preservative which stabilizes the specimen during transport. One 7.5 mL BD Vacutainer^® SST^TM tube and three completely filled 8.5 mL LBgard^® Blood Tubes are required to generate a usable blood sample for a single Oncoguard^® Liver test analysis. It is highly recommended and desired to collect three, completely filled LBgard tubes for the Oncoguard^® Liver test. Three tubes allows for a repeat test in the event of an invalid result generated on the first analysis. We cannot accept other tubes to perform the test.

No. The Blood Collection Kits and tubes must be stored at room temperature (15-25 °C, or 59-77°F). Please do not store the Blood Collection Kit or tubes in the refrigerator or freezer. After collection, ship specimens to the laboratory in the Blood Collection Kit, which includes two temperature-control gel packs to maintain the appropriate temperature.

Call our Customer Care Center at 1-844-870-8870 to order Blood Collection Kits.

The Oncoguard^® Liver test uses serum from the BD Vacutainer^® SST^TM tube for the analysis of alpha-fetoprotein (AFP) and plasma from the LBgard^® Blood Tubes for the analysis of methylated DNA markers (MDMs).

One 7.5 mL BD Vacutainer^® SST^TM tube and three 8.5 mL LBgard^® Blood Tubes are required to generate a usable blood sample for a single Oncoguard^® Liver test analysis. It is very important to completely fill all blood tubes to ensure appropriate volume for testing. NOTE: The three LBgard tubes must be completely filled. The SST tube can be partially filled if there is a concern about being able to collect sufficient sample volumes. It is highly recommended and desired that you collect three, completely filled LBgard tubes for the Oncoguard^® Liver test. Three tubes allows for a repeat test in the event of an invalid result generated on the first analysis.

Yes. The BD Vacutainer^® SST^TM tube must be the first tube collected, followed by the LBgard^® Blood Tubes.

Blood can be drawn any day of the week, but the laboratory does not receive shipments on weekends and holidays. Thus, it is recommended that you collect specimens Monday-Thursday only. For specimens collected Monday-Thursday please ship on the same day as specimen collection for Priority Overnight delivery via the shipping vendor indicated on the pre-paid shipping label on the kit.

To ensure the integrity of the sample, the laboratory must receive the patient specimens within 5 days of collection. Providers should send specimens to our laboratory the same day specimens are collected.

No. Our laboratory cannot accept specimens on weekends and holidays. Please hold the specimens collected Friday through Sunday and on a holiday at room temperature for shipment on the next business day for overnight delivery. We've provided a calendar to help identify days our laboratory can accept samples.

• Yes. As long as the label includes the patient’s first and last name, date of birth, and the date and time of specimen collection. If using the label from your EMR, please ensure that the label is placed lengthwise on the tube over the existing tube label. Ensure that the label is straight and that there is space on the tube for laboratory personnel to see the volume of blood in the tube.
• Please remember, the Blood Collection Kits and tubes must be stored at room temperature (15-25 °C, or 59-77°F). Do not store the Blood Collection Kit or tubes in the refrigerator or freezer. After collection, ship specimens in the Blood Collection Kit, which includes two temperature control gel packs to maintain the appropriate temperature.

No. The specimens should be shipped in the Blood Collection Kit which 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. Only ship specimens in the Blood Collection Kit with the temperature-control gel packs included.

Yes. If the specimens are shipped in the Blood Collection Kit with the two temperature control gel packs included.

Each blood collection tube has an expiration date printed on it. Please only submit specimens in non-expired Blood Collection Kits and blood collection tubes.

Components of the Blood Collection Kit are eligible for reuse. No components will be reused if they have been contaminated by blood during shipment to the laboratory.

There are no known interfering substances with the Oncoguard^® Liver test.

No. The patient is not required to fast before collection.

Blood can be drawn in your own practice by a healthcare professional with basic phlebotomy skills or at a laboratory affiliated with your practice (when contracted to do so).

Exact Sciences does not have a negotiated contract with Quest Diagnostics or LabCorp for phlebotomy services to support the Oncoguard^® Liver test.

Results can be accessed in the EpicCare^® Link^TM portal or will be returned by secure fax typically within a week from receipt of the specimens in the laboratory. If using EpicCare^® Link^TM, you will receive email notifications when results are available. To access results, log into EpicCare^® Link^TM at EpicCareLink.ExactSciencesLabs.com. It is the responsibility of the provider to notify patients of their results.

Results are typically reported within a week from the receipt of the specimens in the laboratory.

The Oncoguard^® Liver test report provides a qualitative “High,”  “Negative,” or “Invalid” result.

If the sample cannot be processed, or if an invalid result is obtained, a new sample will be requested.

A high result does not necessarily mean that the patient has cancer. It means that the Oncoguard^® Liver test detected elevated levels of methylated DNA markers and/or AFP in the blood, which are associated with hepatocellular carcinoma. False positive and false negative results occur with the Oncoguard^® Liver test and appropriate clinical follow-up is important. Patients with high results may follow up with diagnostic multiphase CT or MRI.

• A negative result means that the Oncoguard^® Liver test did not detect significant levels of methylated DNA markers and/or AFP in the blood which are associated with hepatocellular carcinoma. False positive and false negative results occur with the test.
• Patients with negative results should continue in surveillance programs appropriate for the patients. Guidelines recommend testing intervals of 3-6 months for patients at risk for hepatocellular carcinoma. Following a negative result, the patient may be retested with the Oncoguard^® Liver test according to the recommended surveillance intervals.^1,5
• A negative result indicates a low likelihood that hepatocellular carcinoma is present. The chance that a person with a negative Oncoguard^® Liver test has hepatocellular carcinoma is less than 1 in 300 (negative predictive value 99.7%). These data are estimated based on a case control study of individuals at high risk for hepatocellular carcinoma and an estimated 2% prevalence rate within the at-risk population.⁵

• No. The DNA biomarkers in the Oncoguard^® Liver test do not have individually validated reference ranges, and each marker’s clinical significance is influenced by the other markers. Therefore, the DNA biomarker levels cannot be interpreted separately and are not reported separately.
• The AFP measurement is not reported independently.

• The Oncoguard^® Liver test algorithm must incorporate all biomarker measurements to produce a result.
• The DNA biomarkers or AFP biomarker may trigger a high result if sufficiently elevated relative to the reference marker.
• A high result indicates that the biomarker combination has an increased association with hepatocellular carcinoma.
• Any high result may be followed by a diagnostic multiphasic CT or MRI.

The AFP assay utilized in the Oncoguard^® Liver test is an electrochemiluminescence immunoassay but is not designed or validated to be reported independently.

Valid results for all biomarkers must be available to generate the Oncoguard^® Liver test result. Only the combined qualitative test result, as a high, negative, or invalid, is reported.

• Patients with a high Oncoguard^® Liver test and negative multiphase CT or MRI may remain on a surveillance interval that is appropriate for the patient
  • National clinical guidelines recommend that a negative multiphase CT or MRI be followed by repeat testing at an interval and method that depends on the observation categorization.³ 

The Oncoguard^® Liver Patient Engagement program includes patient support tools and provider reports that you can implement in your practice to help patients stay up to date with their recommended hepatocellular carcinoma surveillance.

• Patient educational materials about liver disease, hepatocellular carcinoma (HCC), and the importance of routine hepatocellular carcinoma surveillance are available for you to provide to your patients during office visits.
• Care Navigators are available to contact patients after an Oncoguard^® Liver test has been received in the laboratory to help them understand the testing process.
• Additional educational materials will be sent to patients after a negative test result to help them understand the importance of regular surveillance.
• Reminders will be sent to patients when they are due for their routine surveillance to encourage them to reach out to you to guide them on scheduling or following through with testing.

• Easily accessible reports with information on patients who have been tested and may be due for testing are available to help improve patient care.
• Dedicated account managers are available to answer questions about the Oncoguard^® Liver solution and provide support with test ordering, results, or ordering supplies.

• At this time, the Oncoguard^® Liver test is not covered by most major insurers, including Medicare, Medicare Advantage, or Medicaid.
• We know that coverage for liver cancer surveillance testing is vital to ensuring you have access to the quality information you need about your patients’ health.
• We are working with insurance companies on an ongoing basis to gain coverage, and more information will be provided as coverage expands.

Yes. Please obtain prior authorization for the test following the processes established by your patient’s lab benefit manager. We've provided an Oncoguard^® Liver test Statement of Medical Necessity to assist your practice in obtaining a prior authorization for the test.

Yes. Please have Medicare patients sign an ABN form and include it with the test order. We've provided an Oncoguard^® Liver test ABN to assist your practice in obtaining patient's signature at the time of order.

• Out-of-pocket costs for the Oncoguard^® Liver test will vary based on a patient’s specific health plan coverage policies, co-pays, and deductibles.
• Please call our Customer Care Center at 1-844-870-8870 with questions about coverage and billing for the Oncoguard^® Liver test. Our specialists can help advise patients on the right questions to ask their carrier.

Patients who receive a bill with out-of-pocket responsibilities for the Oncoguard^® Liver test are encouraged to call 1-844-870-8870 and speak with a member of our Customer Care Center to learn about the support we offer, including coverage appeals support, payment plans, or potential eligibility for our Patient Assistance Program.