US-based molecular diagnostics firm Exact Sciences has reported positive data of its Oncoguard Liver liquid biopsy test’s sensitivity and specificity performance in a validation study.
The study results have been published in Clinical Gastroenterology and Hepatology (CGH), a monthly peer-reviewed medical journal.
Oncoguard Liver was developed in partnership with the Mayo Clinic to help identify hepatocellular carcinoma (HCC) for adults suffering from liver cirrhosis or chronic hepatitis B who are at risk of HCC.
It uses a panel of DNA methylation and protein-based biomarkers to detect HCC, which is the most common type of liver cancer.
The single blood-based test was designed to bridge gaps in current HCC testing.
According to the data published in CGH, the Oncoguard Liver liquid biopsy test had 82% early-stage sensitivity, as well as an overall 88% sensitivity and 87% specificity for HCC detection.
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Exact Sciences said that the early-stage sensitivity demonstrated by the test was significantly higher than the existing blood-based test included in HCC guidelines.
Early-stage HCC detection is claimed to improve five-year survival rates from less than 12% to more than 70%.
Mayo Clinic gastroenterologist Dr Lewis Roberts said: “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.”
Exact Sciences said that the current standard of care for HCC surveillance involves monitoring visually through ultrasound, with or without an alpha-fetoprotein (AFP) blood test.
These approaches are said to have variable sensitivity in identifying the disease in its early stages.
Exact Sciences chairman and CEO Kevin Conroy said: “The Oncoguard Liver test advances our work to defeat cancer through earlier detection and bring effective, accessible liquid biopsy tests to health care providers and patients.”
The test is currently available through an early access programme designed to familiarise provider offices with the test and its Patient Engagement Programme.