Industry Buzz: New Liver Cancer Test Being Developed With Eye Toward U.S. Market

Researchers at Georgia Regents University (Augusta, Ga.) have developed a new molecular-based assay for the early detection of liver cancer and are working with the North American branch of multinational firm Biogenex to possibly distribute it in the United States. The test researchers developed stains mir-21, a form of microRNA that appears in liver cancer cells and can survive the chemicals used to prepare slides. In a small retrospective study involving 20 patients, the test was able to correctly diagnose liver cancer in each case. A new study has been expanded to include more than 200 patients. “There is no definitive test for early diagnosis of liver cancer,” said Ravindra Kolhe, M.D., a pathologist and medical director of Georgia Esoteric Labs, Georgia Regents’ commercial development branch. “Our test adds a level of comfort for making the diagnosis.” Liver cancer kills about 22,000 Americans every year, while another 30,000 new cases are diagnosed annually, primarily in men. The five-year survival rate from even the most contained form of the disease is about 28 percent, and it drops precipitously should tumors spread beyond the liver. Among the reasons for the low survival rate is that most patients are asymptomatic until the disease is in an advanced stage, making it too late to perform a liver transplant, partially excise the existing organ, or expose it to heat or cryogenic treatments. Even those patients at a high risk for the disease because of a history of hepatitis cannot be easily tested because cancer cells are not readily visible until they are far along in development. Hepatitis also often leads to cirrhosis, a scarring of the liver that makes slide interpretations more complicated and provides even more cover for the development of cancer cells. Georgia Esoteric worked with BioGenex to develop the test. Kolhe noted that a deal to distribute the assay should it receive regulatory approval “will evolve in later meetings.” Kolhe noted that such an assay would likely be priced in the $250 to $400 range, including pathologist interpretation. Takeaway: Liver cancer must be diagnosed sooner to boost survival rates, and the laboratory sector is responding by developing a new test to identify the cancer earlier.