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.
Getting ahead of cancer is crucial, no matter where people are in their cancer journey
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 Oncoguard® Liver test. While innovative in its own right, the Oncoguard® 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.
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 Oncoguard® Liver test. The case-control study was designed with input from leading hepatologists and followed robust enrollment criteria informed by HCC guidelines.5
Unique cohorts from this study were used throughout the marker selection, algorithm setting, and clinical validation stages of development.
The Oncoguard® Liver test development journey1-4
The Oncoguard® 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.
The Oncoguard® Liver test was deliberately designed to have real-world applicability and relevance for early-stage detection in at-risk patients.
The Oncoguard® Liver solution. Exactly what’s needed today.
See how the Oncoguard® Liver solution can integrate into your workflow.
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.