The University of Pittsburgh and Cepheid announced a three-year collaboration to develop highly sensitive genetic tests for use during surgery to rapidly determine whether cancer has spread. Rare tumor cells in lymph node biopsies often missed by conventional "intra-operative" evaluation would be detected in less than 30 minutes, providing surgical oncologists with critical information to make treatment decisions. The tests could help many cancer patients avoid second surgeries and receive more appropriate treatment, increasing chances of survival.

Under the Cooperative Research and Development Agreement (CRADA), researchers at the University of Pittsburgh Medical Center (UPMC) led by Tony Godfrey, assistant professor of surgery, and James Luketich, associate professor of surgery, will identify and evaluate new genetic markers for several cancers including lung, breast, esophagus, oral, head and neck cancer, and melanoma. Cepheid's Smart Cycler, a commercially available instrument for rapid gene amplification and detection, will be used to validate these markers for detection of cancer in lymph nodes.

Cepheid retains first rights to license and commercialize resulting diagnostic tests for its proprietary systems, including its next generation GeneXpert - a cartridge-based system that integrates and automates all the steps required to detect DNA in complex biological samples.

"Treatment decisions in oncology are strongly influenced by the extent of disease spread," said Dr. Godfrey. "Molecular detection methods, while highly sensitive, have been too technically demanding to produce timely, consistent results. Working with Cepheid, our goal is to automate these complex tests using the GeneXpert system, and deliver definitive results to surgeons while the patient is in the OR, when time-critical treatment decisions need to be made."

Conventional intraoperative methods that involve visual examination of lymph nodes under a microscope often fail to detect micrometastases - difficult-to-detect tumor cells indicating the spread of cancer. An estimated 10 per cent to 20 per cent of breast cancer and melanoma patients must undergo second surgeries due to undetected cancer spread. The new molecular tests will use a variation of the polymerase chain reaction (PCR) method of gene amplification to detect trace levels of cancer-related genes in less than 30 minutes.

Using this method and the Smart Cycler, Dr. Godfrey already has demonstrated rapid detection of the cancer-related gene CEA in lymph node biopsies from esophageal cancer patients. Preliminary results, described at the annual meeting of the American Association for Thoracic Surgery (AATS) in May, suggest the new test is more sensitive, more accurate and more timely than conventional methods used during surgery.

While the primary focus of the collaboration is intraoperative detection of micrometastatic disease, research also will explore clinically useful tests using tumor specific markers for primary diagnosis and early disease detection.