The Oncoguard Liver liquid biopsy test has demonstrated a high sensitivity and specificy for the detection of hepatocellular carcinoma (HCC), including in patients with early-stage HCC.
The Oncoguard Liver liquid biopsy test has demonstrated a high sensitivity and specificy for the detection of hepatocellular carcinoma (HCC), including in patients with early-stage HCC, according to a press release by Exact Sciences Corp.1
Three million Americans are eligible for HCC testing, however, only 1 in 3 patients at-risk of HCC receive the testing needed. Early stage detection of HCC can increase the 5-year survival rate from 12% to 70%.
"We have been working for years to build a simple, high performing blood test for HCC surveillance, and these results indicate that the Oncoguard™ Liver test is poised to be the major advancement our patients deserve and need," said Naga Chalasani, MD, interim chair of the Department of Medicine at Indiana University and lead author of the Clinical Gastroenterology and Hepatology-published paper, in a press release. "The robust validation results were due to a rigorously conducted study, which could not have been possible without diligence and commitment of the entire study team and Exact Sciences' commitment to developing early cancer detection biomarkers."
Oncoguard showed an overall sensitivity of 88% during the study, with 82% early-stage sensitivity and 87% specificity for the detection of HCC.
Patient samples were collected using a prospective, international, multicenter clinical trial (NCT03628651). Patients in the HCC group were untreated, had a clinical HCC diagnosis within 6 months from enrollment, and had at least 1 ≥1 cm lesion. The control group was made up of patients with chronic liver disease who are at-risk for HCC and are undergoing HCC surveillance, without evidence of the disease. 2
In total, 136 HCC cases and 404 control cases were included in the analysis. The median age for both groups was 64 years (P =.83) and liver disease etiology (P =.72). There was a higher rate of men in the HCC cohort (70.6%) than in the control cohort (57.9%). Additionally, the rate of early-stage HCC cases was 59.6%.
The AUC for the ROC curve was 0.91 for the mt-HBT compared to 0.84 for AFP (P <.0001) and 0.88 for GALAD (P =.02). For the mt-HBT, the early-stage AUC was 0.86 compared to 0.78 for AFP (P =.001). The AUC for GALAD was 0.83.
There was an overall sensitivity of 88% for mt-HBT (95% CI: 76-94%), which is higher than the 58% sensitivity for AFP ≥20 ng/ML (95% CI: 44%-71%, P <.0001) and 74% for GALAD ≥-0.63 (95% CI: 60%-84% P =.02).
"The Oncoguard™ Liver test was created with the hope of enhancing early detection of liver cancer, thus putting improved outcomes within reach and empowering patients to stay current with recommended testing ordered by their health care provider," said Lewis Roberts, MB, ChB, PhD, of the Mayo Clinic, who helped develop the test in a press release. "It's rewarding and exciting to be a part of the team that is bringing this new test to patient care."