Exact Sciences and Mayo Clinic said that their panel of blood-based, DNA biomarkers was successful in accurately detecting hepatocellular carcinoma (HCC) in a phase 2 clinical validation study.
Further, the methylated DNA biomarker assay was more accurate than the most wide used serum test, as per results of the trial.
The biomarker panel was 95% sensitive for detecting HCC across all stages with sensitivity among patients with curable-stage disease at 91%, reported Exact Sciences, a molecular diagnostics company.
Overall, the biomarkers achieved specificity of 93%, thereby proving their ability to distinguish between normal and diseased patients.
Sensitivity and specificity are considered to be the key statistical measures of a cancer detection test’s performance, said Exact Sciences.
Exact Sciences chairman and CEO Kevin Conroy said: “These results are further validation of our advanced DNA technology and our multi-biomarker approach for the detection of the deadliest forms of cancer.
“We look forward to advancing this important research in early stage cancer with Mayo Clinic.”
The study was carried out as part of Exact Sciences’ research collaboration with Mayo Clinic with researchers from the two firms using whole-methylome DNA sequencing to detect markers in HCC tissues.
The researchers used DNA collected from blood samples of 244 people. The samples were taken from 98 healthy volunteers, 95 diagnosed across all stages of HCC and 51 with cirrhosis.
The collected samples were tested against 15 biomarkers to identify the combination of six biomarkers that produced the most accurate detection of HCC.
Mayo Clinic’s John Kisiel, who led the study, said: “The potential of an accurate, non-invasive blood test that can identify early-stage disease is very exciting.
“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.”
Kisiel added that the researchers are looking to apply the DNA assay technology across all cancers, while calling the latest findings as a major step toward the objective.