Exact Sciences receives FDA breakthrough designation for HCC blood-based test

Based on newly released research, the FDA awarded breakthrough designation to Exact Sciences' blood-based biomarker test for the most common type of liver cancer , the company announced Nov. 8.

What you should know:

1. The test uses six blood-based biomarkers to diagnose hepatocellular carcinoma.

2. According to newly released data from a study of 443 patients, the test had an 80 percent sensitivity rate and a 90 percent specificity rate for detecting developed HCC.

3. Concerning early-stage HCC, the test had a 71 percent sensitivity rate and a 90 percent specificity rate. Exact's test is an improvement over the commonly-prescribed alpha-fetoprotein test, which has a 45 percent sensitivity rate and a 90 percent specificity rate. AFP tests are among the most commonly used for diagnosing liver cancer.

Exact CEO and Chairman Kevin Conroy commented on the potential the test has, saying, "A more sensitive and convenient blood-based test could help catch the disease earlier, which may lead to better outcomes."

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