This grant, entitled “Early Detection of Pancreatic Cancer Using ICE COLD-PCR”, is a joint project with Tony Hollingsworth, Ph.D., University of Nebraska Medical Center, who heads a leading research team studying pancreatic cancer and other diseases of the pancreas, such as pancreatitis.
Pancreatic cancer is difficult to diagnose at an early stage. In the disease’s late stage response to therapy is poor with an average survival of six months after diagnosis and a five-year survival rate of less than 4 percent. This project aims to develop a highly sensitive genetic test that can detect pancreatic cancer biomarkers in blood or urine, enabling much earlier diagnosis and more effective treatment.
With Dr. Hollingsworth’s team, Transgenomic will test the application of its proprietary ICE COLD-PCR technology to the high sensitivity detection of key mutations in pancreatic cancer in pancreas, urine and blood.
If promising results are obtained from these Phase I studies, a Phase II STTR application will be submitted to include more comprehensive studies of ICE COLD-PCR detection of DNA mutations associated with early and late stage pancreatic cancer in humans. This could ultimately lead to a simple, highly sensitive diagnostic assay for the early detection of pancreatic ductal adenocarcinoma.
“This successful peer-reviewed grant award reinforces the promise of our ICE COLD-PCR technology in being able to deliver high-sensitivity genetic information to support the treatment of oncology patients, such as those suffering from pancreatic cancer,” said Craig Tuttle, Chief Executive Officer of Transgenomic. “Both the financial support of the NIH and working with prominent cancer research groups, such as Dr. Hollingsworth and his team, will accelerate the development of our high-sensitivity cancer diagnostic assays".
“This grant funds research that builds upon our ongoing collaboration with Transgenomic, which is also facilitated by our active participation in the Early Detection Research Network of the National Cancer Institute,” said Dr. Hollingsworth. “This research project is an excellent example of how an academic-industrial collaboration can rapidly determine the potential utility of a promising diagnostic or prognostic assay for one of the most insidious diseases – pancreatic cancer. It is highly commendable that Transgenomic, a small business, is willing to attack the difficult problem of diagnosing pancreatic cancer.”
ICE COLD-PCR technology, exclusively licensed by Transgenomic for DNA sequencing analysis, was developed in collaboration with the Dana-Farber Cancer Institute and is supported by multiple validation studies confirming reproducible mutation detection at very high sensitivity – up to 1,000 to 10,000 times more sensitive than traditional sequencing and PCR techniques. The technology is also being evaluated in an ongoing study with The University of Texas MD Anderson Cancer Center to analyze DNA isolated from circulating tumor cells (CTCs).