Exact Sciences targets an unmet need

Focusing on finding cancer earlier in an at-risk population

Getting ahead of cancer is crucial, no matter where people are in their cancer journey

From earlier cancer detection to treatment guidance and monitoring, we want to help people get the answers they need to make more informed decisions across the cancer continuum.

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With this goal in mind, Exact Sciences undertook a scientifically rigorous development path to address the unmet need for reliable early detection of hepatocellular carcinoma (HCC), ultimately introducing the OncoguardTM Liver test. While innovative in its own right, the OncoguardTM Liver test is part of a much larger, more comprehensive approach to HCC detection—an approach that improves access by offering simple and convenient blood collection, performance that may improve upon the current standard of care, and a tailored Patient Engagement Program that may improve patient adherence to routine HCC testing.

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Robust scientific development

In collaboration with leading experts at Mayo Clinic, Exact Sciences utilized a clinical development platform robustly designed to provide reliable results that translate into real-world clinical practice, giving clinicians enhanced confidence in their HCC testing.


One of the largest HCC case-control studies supported the development and validation of the OncoguardTM Liver test. The case-control study was designed with input from leading hepatologists and followed robust enrollment criteria informed by HCC guidelines.5

Included >70 sites across the United States, European Union, and Asia

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Yielded 1400 disease etiology-matched HCC surveillance controls and 700 clinically diagnosed HCC cases

Unique cohorts from this study were used throughout the marker selection, algorithm setting, and clinical validation stages of development.

The OncoguardTM Liver test development journey1-4

Biomarker discovery

Over 300 biomarkers from tissue and plasma identified

Marker selection

10 methlylated DNA markers (MDMs) and multiple proteins identified and assessed

Algorithm setting

Algorithm using 3 methylated markers + AFP + Sex was identified to deliver high sensitivity for early-stage HCC

Assay clinical validation

Locked algorithm used to independently validate of clinical performance of the OncoguardTM Liver test

The OncoguardTM Liver test consistently demonstrated high sensitivity for early-stage HCC detection throughout all stages of development. Final performance characteristics were established by evaluating a panel of blood specimens from this large cohort, leading to a blood-based test that can detect HCC at any stage—with strong sensitivity at early stages when it matters most—and maintains performance across disease etiologies.

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The OncoguardTM Liver test was deliberately designed to have real-world applicability and relevance for early-stage detection in at-risk patients.

See how the OncoguardTM Liver test can fit into your workflow

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References: 1. 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 2. Kisiel JB, Dukek BA, Kanipakam RVSR, et al. Hepatocellular carcinoma detection by plasma methylated DNA: discovery, phase I pilot, and phase II clinical validation. Hepatology. 2019;69(3):1180-1192. doi:10.1002/hep.30244 3. Chalasani NP, Ramasubramanian TS, Bhattacharya A, et al. Combined methylated DNA and protein markers: an accurate blood-based test for early-stage detection of hepatocellular carcinoma. Abstract presented at: the American Association for the Study of Liver Disease; November 8-12, 2019; Boston, MA. 4. Chalasani NP, Bhattacharya A, Book A, et al. Algorithm for blood-based panel of methylated DNA and protein markers to detect early-stage hepatocellular carcinoma with high specificity. J Clin Oncol. 2020;38(15);4577-4577. doi:10.1200/JCO.2020.38.15_suppl.4557 5. Exact Sciences Corporation. Blood sample collection to evaluate biomarkers for hepatocellular carcinoma. NLM identifier: NCT03628651. Accessed September 2, 2020. http://www.clinicaltrials.gov/ct2/show/NCT03628651