Celera Genomics, a pharmaceutical company specializing in genome-based therapeutics, announced that it has developed a test that will help predict cirrhosis in patients with chronic hepatitis C (HCV). Cirrhosis is a life-threatening complication of HCV, characterized by liver scarring, and can ultimately lead to the deterioration of all the organ’s vital functions. Celera believes it has pinpointed the high-risk and low-risk genetic patterns that will allow doctors to predict early on when or if a patient will require treatment. HCV patients who develop cirrhosis or liver-related complications require costly treatments that come with debilitating side effects. However, some patients can live for years without needing treatment.
Scott L. Friedman, MD, is Professor of Medicine and Liver Diseases Division Chief at the Mount Sinai School of Medicine in New York. Mount Sinai and Celera collaborated on the development of the test. “The current therapies to treat hepatitis C are fairly noxious. One of the tough decisions we face as clinicians is who should be treated with current antiviral therapies and who can afford to wait,” said Friedman.
The recent mapping of the human genome was integral in the development of the test. Celera scanned the DNA of 1,000 individuals who had HCV for at least 10 years, examining 25,000 genetic variations per patient. Researchers found seven gene pattern variations most closely linked to the development of cirrhosis. They then tested the DNA samples of an additional 448 long-term HCV patients, predicting with increased accuracy which ones had cirrhosis.
Celera, which is headquartered in Rockville, MD, may be able to license the technique to a laboratory by the end of the year because tests conducted at a single lab do not require U.S. Food and Drug Administration (FDA) approval. The company has also indicated that it will eventually seek an FDA license for the test in order to sell it more broadly.
Friedman has expressed optimism, adding that the test, “represents a potential breakthrough once it’s validated independently in large numbers of patients.” However, confidence for the test’s potential is not universal. David A. Brenner, MD, Chairman of Medicine at the Columbia University College of Physicians and Surgeons and editor in chief of the journal Gastroenterology, points to mixed results in the data. “A lot of these papers look good in the first data set and the next data set is not encouraging,” he said.
Celera presented test data at the 41st Annual Meeting of the European Association for the Study of the Liver on April 26-30, 2006, in Vienna, Austria.
Source: The New York Times, April 26, 2006