NanoString® Technologies has secured an option to an exclusive worldwide license for a 186-gene signature that could be used to determine the prognosis of patients diagnosed with the most common type of liver cancer, hepatocellular carcinoma (HCC), or with hepatitis C-related early-stage cirrhosis. NanoString secured the option from The Broad Institute, acting on behalf of the inventors’ institutions. During the period in which the option can be exercised, NanoString plans to assess the feasibility of developing an in vitro diagnostic assay based on the HCC gene signature for use on the nCounter® analysis system.

“This platform could provide the multiplexed gene expression capabilities needed for clinical diagnostic use of this HCC gene signature, especially given the potential for a large-scale global surveillance testing opportunity,” said Yujin Hoshida, M.D., Ph.D., who led the discovery of the signature while a postdoctoral fellow in the laboratory of Broad Institute CSO Todd Golub, M.D., and is on the faculty at Mount Sinai.

A paper in the New England Journal of Medicine in 2008 by Hoshida, et al, described the HCC gene signature in connection with a method for conducting gene expression analysis on RNA extracted from liver tissue adjacent to HCC tumors. Using this method, the authors discovered a 186-gene signature that identifies those HCC patients who have a poor prognosis because of a high rate of recurrence after primary treatment. This gene signature was highly correlated with survival in a training set of 82 Japanese patients and was validated in an independent set of 225 patients from the United States and Europe. A paper recently published online in Gastroenterology by Hoshida et al, demonstrated that this same 186-gene signature also identifies those patients with hepatitis C-related early-stage cirrhosis who have a poor prognosis because of their high rate of developing HCC.

“By identifying those HCC patients who are at the greatest risk of recurrence, doctors may choose to monitor these patients more regularly or to enter them into clinical trials in the adjuvant setting to reduce the risk of HCC recurrence,” said Josep M. Llovet, M.D., professor of medicine and director of the HCC Program, Liver Diseases, Mount Sinai; professor ICREA at IDIBAPS-Hospital Clínic; and a co-inventor of the HCC gene signature. “The signature also identifies patients with hepatitis C-related early-stage cirrhosis at high risk of developing HCC who are good candidates for entry into surveillance programs or clinical trials of new agents in the chemo-preventive setting.”

The HCC gene signature was invented by Dr. Golub and a group of researchers from the Dana-Farber Cancer Institute, the Icahn Sinai School of Medicine at Mount Sinai, Massachusetts General Hospital, Massachusetts Institute of Technology, The Hospital Clínic of Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Institució Catalana de Recarca i Estudis Avançats (ICREA), and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd).

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