Simple, smarter HCC testing that works for more patients

The OncoguardTM Liver test is a sophisticated, yet simple, single blood test delivering high sensitivity and specificity to aid consistent and reliable hepatocellular carcinoma (HCC) detection.

The convenience of accurate blood-based testing helps streamline HCC testing, making it easier for patients to follow through with their care.

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A unique set of markers clarifies the information

The OncoguardTM Liver test analyzes plasma for methylated DNA markers (MDMs) and serum for alpha-fetoprotein (AFP).

Methylated DNA markers are a class of biomarkers that may demonstrate aberrant methylation of gene promoter regions, which is common and widespread in HCC cells, even in early stages of the disease.1

High levels of AFP have been shown to be associated with liver diseases, including HCC,2 which is why AFP is the most widely used serological marker to help establish an HCC diagnosis.3

This unique combination of DNA and protein biomarkers employed in the OncoguardTM Liver test exhibits an additive association with HCC.

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Sophisticated analysis
Actionable results

The OncoguardTM Liver test uses a sophisticated algorithm combining the patient’s biological sex with results from the analysis of AFP and the MDMs to generate an actionable qualitative result.

Positive result

A positive test result may indicate the presence of HCC. When a positive result is reported, additional clinical assessment to confirm the presence of HCC is suggested (e.g., diagnostic imaging procedures).

Negative result

A negative test result indicates a lower likelihood of the presence of HCC. When a negative result is obtained, a 3- to 6-month testing cadence is suggested.

In rare instances, a technical failure or insufficient clinical material in the sample yields an invalid result.

False positive and false negative results are possible with the OncoguardTM Liver test. In the clinical lab validation study, the false positive rate was 13% and the false negative rate was 12%.4

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By combining high sensitivity and specificity to detect HCC with easy-to-interpret qualitative results, the OncoguardTM Liver test may help you take action sooner and achieve the goal of better outcomes for your patients.

Learn more about the clinical performance of the OncoguardTM Liver test

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References: 1. Oussalah A, Rischer S, Bensenane M, et al. Plasma mSEPT9: a novel circulating cell-free DNA-based epigenetic biomarker to diagnose hepatocellular carcinoma. EBioMedicine. 2018;30:138-147. doi: 10.1016/j.ebiom.2018.03.029 2. Kew M. Alpha-fetoprotein in primary liver cancer and other diseases. Gut. 1974;15(10):814-821. doi: 10.1136/gut.15.10.814 3. Bai D-S, Zhang C, Chen P, Jin S-J, Jiang G-Q. The prognostic correlation of AFP level at diagnosis with pathological grade, progression, and survival of patients with hepatocellular carcinoma. Sci Rep. 2017;7(1):12870. doi: 10.1038/s41598-017-12834-1 4. 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