publication date: Nov. 15, 2019

Drugs & Targets

FDA grants Breakthrough Device Designation for Exact Sciences blood-based test for detection of HCC

FDA granted Exact Sciences’ DNA methylation based liquid biopsy test Breakthrough Device designation for detection of hepatocellular carcinoma, based on recently presented data.

“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,” lead author Naga Chalasani, associate dean for Clinical Research at Indiana University School of Medicine and director, Division of Gastroenterology and Hepatology, said in a statement.

A study of 443 patients by Exact Sciences and its collaborators demonstrated 80% sensitivity at 90% specificity with a novel combination of six blood-based biomarkers for the most common type of liver cancer, HCC. The study also showed 71% sensitivity for early stage HCC at 90% specificity. The study compared performance to the alpha-fetoprotein test, which demonstrated 45% sensitivity at 90% specificity for early stage HCC.

Chalasani presented the data Nov. 10 at the 2019 annual meeting for the American Association for the Study of Liver Diseases in Boston.

The data are included by AASLD’s Scientific Program Committee in The Best of The Liver Meeting, a distinction that recognizes abstracts for their rigorous scientific methodology and key insights for patient care and ongoing research.

Current guidelines recommend at-risk patients undergo testing every six months using ultrasound with or without the AFP blood test. Combined, US and AFP have demonstrated 63% sensitivity for early stage cancers. Nearly half of Medicare patients tested for HCC receive only the AFP test, which in Exact Sciences’ study was less sensitive for HCC detection than US and AFP combined. Three-year survival … Continue reading FDA grants Breakthrough Device Designation for Exact Sciences blood-based test for detection of HCC

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