Transgenomic, Inc. announced that it has acquired an exclusive worldwide license to Montefiore Medical Center’s patent application, “Method of Determining the Sensitivity of Cancer Cells to EGFR Inhibitors including cetuximab, panitumumab and erlotinib”. The invention relates to the discovery by Montefiore scientists and collaborators that tumour-specific mutations in the genes PIK3CA and PTEN can aid in predicting patient non-response to epidermal growth factor receptor (EGFR) inhibitors, a widely prescribed class of cancer drugs.

Transgenomic is incorporating the PIK3CA and PTEN gene assays into its rapidly expanding menu of cancer profiling tests available through its clinical reference laboratories and is developing testing kits for sale to other labs. Testing of these genes is also being offered to support drug development research by pharmaceutical companies that have been expressing great interest in these genes and in Transgenomic’s proprietary, ultra-sensitive mutation-detection technologies. At the American Association for Cancer Research meeting in April of this year, Transgenomic described methods for detecting tumour-specific mutations at such low levels that it may be possible to identify them in patients’ blood samples, not just in surgically obtained tumour tissues.

“This exclusive license from Montefiore strengthens our cancer-related diagnostic test portfolio and is integral to the continued development of our leadership position in oncology,” said Craig Tuttle, CEO of Transgenomic. “At Transgenomic, we are uniquely equipped to maximize the value of these genetic discoveries by combining them with the unparalleled sensitivity of our proprietary mutation-detection technologies. Our exclusive access to this new intellectual property will enable us to provide the most comprehensive analysis for predicting response to cancer treatment in the current market.”

Monoclonal antibody therapeutics that target the epidermal growth factor receptor (EGFR) are new and often highly effective treatments for metastatic colorectal cancer and other aggressive cancers.

Unfortunately, some patients do not benefit from these drugs because their cancers have mutations in genes within the EGFR pathway. The American Society of Clinical Oncology has recommended that colorectal cancer patients who are candidates for anti-EGFR therapy should be tested for mutations in the gene K-RAS as patients with mutations in K-RAS do not benefit from these therapies. Studies from Montefiore Medical Center and elsewhere have demonstrated that mutations in PIK3CA and PTEN can also cause anti-EGFR therapies to be ineffective. A diagnostic panel that comprehensively tests all these genes has the potential to greatly improve the tailored use of these cancer treatments.

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.

As the University Hospital for Albert Einstein College of Medicine, Montefiore is a premier academic medical centre nationally renowned for its clinical excellence and scientific discovery; compassionate, patient-centred model of care; commitment to its community; and medical education, including the second largest residency programme in the country.