Genetic Test to Give Clues on Treatment of Hepatitis C

Today, Rockville, Md.-based Celera Genomics plans to announce it has developed a new genetic test that will help predict which hepatitis C-infected patients will suffer liver scarring and thus are most in need of treatment. While experts differ in their opinions, it has been estimated that only 20 percent of the 3 million Americans chronically infected with the virus will develop this scarring, or cirrhosis, which can lead to liver failure or cancer. Previously, it has not been possible to assess which patients are at greatest risk.

Dr. Scott L. Friedman, chief of the division of liver diseases at Manhattan's Mount Sinai School of Medicine, helped develop the test. "The current therapies to treat hepatitis C are fairly noxious," he said. The expensive drug therapy can cause side effects including fever, depression, and severe fatigue, and many patients can live for decades without requiring treatment. "One of the tough decisions we face as clinicians is who should be treated with current antiviral therapies and who can afford to wait," Friedman said.

Working with a study group of about 1,000 patients infected with hepatitis C for 10 years or more, Celera looked at 25,000 genetic variations in each patient and identified seven that best indicated the risk of developing cirrhosis. When tested on the DNA of 448 other longtime patients, the test yielded fairly accurate predictions of which had cirrhosis. Among early-stage patients, those with a high-risk gene pattern had about six times the chance of developing cirrhosis compared with those whose genes indicated low risk.

Celera hopes to license the test to a laboratory that could offer it as early as year's end, said President Kathy P. Ordonez. Tests performed by a single lab do not require Food and Drug Administration approval. While the lab would set the test's price, Ordonez expects it to cost about $1,000 or slightly less. The company will seek FDA approval to offer the test more widely; however, this will take more time, she said, especially if the agency requires additional data.

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