Transgenomic, Inc, a leading global biotechnology company, has completed a licensing option with the Dana- Farber Cancer Institute, Boston with regard to a method known as Cold-PCR. This variation of the standard PCR technology enriches mutations in samples where normal DNA predominates. Cold-PCR was invented at Dana-Farber by Dr Mike Makrigiorgos who has demonstrated its effectiveness in enriching for mutations in cancer-related genes in samples where DNA sequencing cannot detect very low concentrations of somatic DNA mutation.

"We are very excited to be able to work with Dana-Farber on continuing to develop this technology. Cold-PCR has the potential to further increase the sensitivity of Transgenomic's WAVE DHPLC and Surveyor Nuclease products for mutation detection in cancer and mitochondrial diseases," said Eric Kaldjian, CSO at Transgenomic. "In combination, Cold-PCR and WAVE/Surveyor have the potential to detect one mutant copy of DNA out of a thousand to as many as ten thousand normal copies. This will be particularly valuable in cancer-related mutation detection of free DNA in blood and body fluids and in producing a mutation profile of primary tumours to predict resistance to targeted therapies. It could also have application in analysis of mitochondrial DNA heteroplasmies."

"We are delighted to be able to develop jointly the application of Cold-PCR with Transgenomic's existing technologies," said Dr Mike Makrigiorgos, director of Medical Physics and Biophysics Division at Dana-Farber and an associate Professor of Radiation Oncology at Harvard Medical School. "We believe that coupling Cold-PCR with DHPLC and Surveyor Nuclease promises a significant solution to high sensitivity detection of somatic mutations that are key to cancer biology."

Cold-PCR will have applicability in detection of cancer-related mutations where critical mutations are present at a very low percentage compared to normal DNA. Examples would be in blood and urine or where the tissue collected contains mostly normal cells. This would allow clinicians to use less intrusive methods for genetic analysis or allow more efficient use of tumour tissue samples. Additionally the method could enhance the detection of the emergence of cancer drug resistance mutations, allowing early detection of relapse.

Transgenomic CEO Craig Tuttle said, "We believe that Cold-PCR is an important addition to our high-sensitivity mutation detection portfolio of cutting edge technologies. It will allow us to continue to be able to offer affordable, state-of-the-art solutions to challenging areas of genetic analysis such as early detection of cancer development, drug resistance and relapse as well as expanding our mitochondrial DNA toolbox."