Researchers at Exact Sciences Corp. and Mayo Clinic announced significant progress toward developing a panel of novel, blood-based, DNA biomarkers that could accurately detect hepatocellular carcinoma (HCC), the most common cancer that originates in the liver. The researchers detailed their findings during a presentation today at Digestive Disease Week.
Using DNA extracted from the blood samples of 244 people, including 95 diagnosed across all stages of HCC, 51 with cirrhosis, and 98 healthy volunteers, researchers tested the samples against 15 biomarkers to identify the combination of six biomarkers that yielded the most accurate detection of HCC.
The biomarker panel was shown to be 95 percent sensitive for detecting HCC across all stages. Sensitivity among patients with curable-stage disease was 91 percent. The panel has overall specificity of 93 percent, demonstrating its ability to discriminate between normal and diseased patients. Sensitivity and specificity are the most important statistical measures of a cancer detection test’s performance.
HCC accounts for nearly 90 percent of all liver cancers and is the fastest-growing cause of cancer-related death in the United States.1 Mayo Clinic experts predict that liver and bile duct cancers will be the third-leading cause of cancer deaths in the United States by 2030 due, in part, to the obesity epidemic.
Individuals diagnosed with cirrhosis have the greatest risk of developing HCC, and it is recommended that they undergo ultrasound and blood monitoring every six to 12 months. The three-year survival rate for patients regularly surveilled is approximately 60 percent, compared to approximately 30 percent for those who don’t undergo regular surveillance.4When HCC is detected early and treated, patient survival rates improve significantly. Exact Sciences estimates that more than 3 million Americans are eligible for HCC surveillance.
“The potential of an accurate, non-invasive blood test that can identify early-stage disease is very exciting,” said John Kisiel, M.D., the gastroenterologist and assistant professor of medicine at Mayo Clinic Medical School who led the study. “This could potentially transform the way patients are monitored and lead to the identification of many more curable-stage tumors than we typically see today.”
Dr. Kisiel said the current options for monitoring at-risk patients are “sub-optimal.”
“We estimate that fewer than half of at-risk patients are tested regularly, and some estimates suggest the monitoring rate is less than 20 percent in primary care settings, where most people get their care,” Dr. Kisiel said.