Transgenomic, Inc., a global biotechnology company, has announced that the US Patent and Trademark Office (USPTO) has issued patent number US 8,137,919 entitled “Method of Determining the Sensitivity of Cancer Cells to EGFR Inhibitors including Cetuximab, Panitumumab and Erlotinib”.

The patent was exclusively licensed to Transgenomic by the Montefiore Medical Centre (Bronx, NY, US) and includes all tumour types and targeted therapies that may be influenced by PIK3CA mutation status.

Montefiore inventors Drs Sanjay Goel and John Mariadason have demonstrated that key mutations in the gene PIK3CA are powerful predictors for the efficacy of EGFR-targeted therapies such as cetuximab (Erbitux), panitumumab (Vectibix) and erlotinib (Tarceva). These findings were published in the June 2012 issue of Clinical Colorectal Cancer by the same researchers and have been reproduced in other independent studies.

Assays using Transgenomic’s proprietary SURVEYOR Scan, REVEAL ICE COLD-PCR and BLOCker- Sequencing for complete detection of PIK3CA mutations have been developed. The extremely high sensitivity of Transgenomic’s REVEAL ICE COLD-PCR technology enables the use of virtually any sample type including blood and circulating tumor cells. Non-invasive testing allows for more frequent and accurate profiling of a cancer as it responds to treatment and gains additional mutations.

“The recent issuing of this important patent is a significant milestone in the continued development of our genetic biomarker intellectual property portfolio,” said Craig Tuttle, CEO of Transgenomic. “Since exclusively licensing this patent we have been able to effectively apply our high sensitivity mutation detection technologies, such as SURVEYOR Scan, REVEAL ICE COLD-PCR and BLOCker-sequencing, to PIK3CA assays in order to be able to detect genetic variations in very low mutant load samples, such as plasma, serum and circulating tumour cells.”

Tuttle added that, “The number of genes associated with the effectiveness of targeted cancer treatments is increasing; our strategy is to provide a complete portfolio of best-in-class kits for clinically relevant mutations using our proprietary and extremely sensitive technologies. These assays will also be available through our CLIA and Pharmacogenomics laboratories to support clinicians and pharmaceutical research and trials.”

Transgenomic Inc. is a global biotechnology company advancing personalized medicine in cancer and inherited diseases through its proprietary molecular technologies and world-class clinical and research services.