Celera To Announce Test for Cirrhosis in Hepatitis C Patients
Maryland-based Celera Genomics on Wednesday was expected to announce a genetic test that it says could predict if a patient with hepatitis C is likely to develop cirrhosis of the liver, the New York Times reports. It is estimated that about 20% of the roughly three million U.S. residents with hepatitis C eventually will develop cirrhosis -- a severe scarring of the liver that can lead to liver failure or liver cancer. There currently is no test to predict which patients are at greatest risk of developing cirrhosis, and it is difficult for doctors to determine who requires treatments, which can cost $30,000 annually and cause severe fatigue and other side effects, the Times reports. To develop the test, Celera examined 25,000 genetic variations in DNA from each of about 1,000 people who had hepatitis C for at least 10 years, a period long enough that some portion would have developed cirrhosis. Researchers identified seven genetic variations that were most effective in calculating a risk of developing cirrhosis. They used the test on 448 other "longtime" hepatitis patients, finding that it was fairly accurate in predicting who had cirrhosis, the Times reports. Among patients with early-stage liver disease, those with a high-risk gene pattern had a sixfold chance of developing cirrhosis compared with those with low-risk gene patterns, Celera said. Celera will present data from the study on Friday at the annual meeting of the European Association for the Study of the Liver. Celera President Kathy Ordonez said the company hopes to license the test to a laboratory that could market it by the end of the year. Ordonez said she expects the test to cost about $1,000 but added that pricing ultimately would be up to the laboratory. FDA approval is not required for tests performed by a single laboratory. Celera will seek FDA approval so it can market the test more widely, Ordonez said (Pollack, New York Times, 4/26).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.