Frequently asked questions

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Intended use population

What is the OncoguardTM Liver solution?

What is the OncoguardTM Liver test?

Who is the intended patient for the OncoguardTM Liver test?

Who is not an appropriate patient for the OncoguardTM Liver test?

What are some factors that qualify a patient for hepatocellular carcinoma surveillance?

Can a patient assigned as intersex at birth use the OncoguardTM Liver test?

Can a patient on hormone therapy for a gender transition use the OncoguardTM Liver test?

Test Performance

Baseline knowledge on Clinical Statistics terminology: Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), False Positive (FP), False Negative (FN).4

What is sensitivity of the OncoguardTM Liver test?5

What is the false negative rate of the OncoguardTM Liver test?5

What is the OncoguardTM Liver test’s specificity?

What is the false positive rate of the OncoguardTM Liver test?

How might I incorporate the OncoguardTM Liver test into my clinical workflow?

Is the OncoguardTM Liver test FDA approved?

Warnings and Precautions

What are the warnings and precautions for the OncoguardTM Liver test?

Account Setup, Test Ordering, and Supplies

How do I get set up to start using the OncoguardTM Liver test?

How do I order a test?

Are there any special supplies needed to perform the OncoguardTM Liver test?

Are special specimen collection tubes required for the assay?

Should the Blood Collection Kits and tubes be stored in the refrigerator or freezer?

How do I get supplies?

Sample collection

What sample types are used for testing?

How much blood is required to do the testing?

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

Must the blood draw be performed on a particular day of the week?

After collection, how much time does a sample have to get back to the lab?

I collected the blood sample on Friday, Saturday, Sunday or Holiday. Is it OK to ship it on the day of collection?

May I label the tubes with a label from my in-house EMR system?

Should the specimen collection tubes be shipped with an ice pack or in dry ice?

Will the specimen be OK to ship during extreme weather?

What is the shelf life of the Blood Collection Kit, the LBgard Blood Tubes and BD Vacutainer SST tubes in the Blood Collection Kit?

Are the specimen collection kit boxes reused for future orders?

Are there medications, foods, or other substances that interfere with the assay?

Is the patient required to fast before blood collection?

Where can the patient get their blood drawn?

Can my Quest or LabCorp phlebotomist draw blood for this test?

Result reporting

How do I receive the results?

What is the turnaround time to receive results?

How are results reported?

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

What does a positive OncoguardTM Liver test result mean? How do I counsel my patient?

What does a negative OncoguardTM Liver test result mean? How do I counsel my patient?

Can I receive the OncoguardTM Liver Test Composite Score?

Can the healthcare provider receive individual biomarker results?

Is it possible for alpha-fetoprotein (AFP) itself to drive a positive result from the algorithm, in the absence of any elevated DNA biomarkers?

Is the alpha-fetoprotein (AFP) component of the OncoguardTM Liver test different from commercially available AFP test?

If a valid result is not available from any of the DNA or alpha-fetoprotein (AFP) components (due to not enough material/degraded sample/not returned/etc.), are the results of the other components reportable?

Interpretation of results

Is additional follow-up necessary for a patient who has a positive OncoguardTM Liver test followed by a negative CT/MRI scan?

Patient Engagement Program

What is the Patient Engagement program included as part of the OncoguardTM Liver solution?

What Patient support tools are available?

What Provider resources are available?

Coverage and Billing

Is the OncoguardTM Liver test covered by insurance?

Is prior authorization required for this test?

Is an Advance Beneficiary Notice (ABN) required for this test?

How much will my patients have to pay for this test?

What options are available for patients who cannot afford to pay for the test?

References: 1. Benson AB, 3rd, D'Angelica MI, Abbott DE, et al. NCCN Guidelines Insights: Hepatobiliary Cancers, Version 1.2020. J Natl Compr Canc Netw. 2020;15(5):563-573. 2. Heimbach JK, Kulik LM, Finn RS, et al. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018;67(1):358-380. 3. Marrero JA, Kulik LM, Sirlin CB, et al. Diagnosis, Staging, and Management of Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2018;68(2):723-750. 4. Habib ZA. Maternal serum alpha-feto-protein: its value in antenatal diagnosis of genetic disease and in obstetrical-gynaecological care. Acta Obstet Gynecol Scand Suppl. 1977;61:1-92. 5. Chalasani NP, Porter K, Bhattacharya A, Book AJ, Neis BM, Xiong KM, Ramasubramanian TS, Edwards V DK, Chen I, Johnson S, Roberts LR, Kisiel JB, Reddy KR, Singal AG, Olson MC, Bruinsma JJ, Validation of a novel multi-target blood test shows high sensitivity to detect early-stage hepatocellular carcinoma, Clinical Gastroenterology and Hepatology (2021), doi: https:// doi.org/10.1016/j.cgh.2021.08.010