A new test for liver cancer being developed by Madison-based Exact Sciences has been granted “breakthrough device” designation by the FDA, promising an easier pathway to market.
The new test detects hepatocellular carcinoma, the most common form of liver cancer. It relies on six blood-based biomarkers. Company Chairman and CEO Kevin Conroy says recently published study results show an improvement over other diagnostic tests.
A release from the company shows more than 42,000 Americans and 780,000 people around the world are diagnosed with liver cancer each year, with HCC accounting for about 90 percent of cases.
“There is a significant, worldwide unmet need for a blood-based, early detection diagnostic test for liver cancer in persons with elevated risk for the disease,” said Dr. Naga Chalasani, associate dean for clinical research at the Indiana University School of Medicine. He was the lead author of the study conducted in partnership with Exact Sciences.
The study found the test has 80 percent sensitivity to the liver cancer, and 71 percent sensitivity for earlier cases. For comparison, the alpha-fetoprotein test — used to detect birth defects as well as various cancers — had 45 percent sensitivity under the same conditions.
The liver cancer test is still being developed, and Exact Sciences has announced the new test will hit the market in the second half of 2020. The release shows the company plans to gather performance data to support adoption of the test and inclusion into health guidelines. Read the full story here.