Cepheid, a leading molecular diagnostics company and the Knight Cancer Institute at Oregon Health & Science University (OHSU) announced a collaboration to develop a menu of advanced molecular diagnostics to be performed on the GeneXpert system.

The collaboration will focus on the development of clinical oncology tests for the GeneXpert system and will establish a system for clinically validating the tests through the Knight Diagnostic Laboratories, a division of the Knight Cancer Institute at OHSU. The alliance includes an exclusive license to OHSU intellectual property in prostate cancer and intellectual property co-developed by Lawrence Berkeley National Laboratory and OHSU in breast cancer.

The collaborative research will be led by Joe W. Gray, associate director of Translational Research for the Knight Cancer Institute at OHSU, and Michael Bates, MD, Cepheid's Vice President, Oncology R&D. Initial projects will focus on breast and prostate cancers, including development of Xpert breast cancer signature, a diagnostic test designed to predict the risk of recurrence in newly diagnosed patients, and Xpert Prostate Cancer Recurrence Risk, a test designed to predict the likelihood of recurrence in patients following surgery, as well as other prostate cancer applications. Each assay will take advantage of the GeneXpert system's ability to quantitatively assess multiple RNA targets extracted from formalin-fixed, paraffin-embedded tumour tissue.

"Cepheid is honoured to be working with Dr Gray and his colleagues at OHSU with the goal of making their impressive scientific discoveries in the field of oncology and personalized medicine widely available to physicians for the benefit of their patients," said David Persing, Cepheid's chief medical and technology officer. "We look forward to partnering with OHSU to add a number of high impact oncology tests to the Xpert portfolio, delivering the most advanced diagnostic solutions for cancer patients while also achieving the accuracy, reproducibility, rapid turn-around-time, and cost-effectiveness that characterize the GeneXpert platform."

"Forming an alliance with one of the world's most innovative clinical test leaders represents an important opportunity for OHSU to explore how it can leverage its expertise in cancer and other disease research to develop more advanced diagnostic tools," said J. Timothy Stout, OHSU Vice President, Technology Transfer and Business Development. "We are particularly interested in Cepheid's technology, because it makes sophisticated testing more cost efficient and allows for fast turnaround times, which can make a large difference in improving the delivery of health care."

The collaboration's first projects are focused on building upon research conducted at the Knight Cancer Institute to improve molecular testing to ensure patients receive the right treatment for their tumour's biology — the primary goal of personalized cancer medicine.

"Prostate and breast cancer are the two most commonly occurring cancers in the United States and, together with Cepheid, we are determined to develop reliable, rapid and inexpensive diagnostic assays that are readily available to physicians and their patients," said Gray, who is also Director of the OHSU Center for Spatial Systems Biomedicine. "As more information emerges about the molecular abnormalities that determine tumour behaviour, we will be able to develop assays for the Xpert system that will allow us to identify and more precisely treat the most lethal forms of breast and prostate cancer, while sparing others from unnecessary treatments."

The collaboration includes an option for the Knight Diagnostic Laboratories to develop Laboratory Developed Tests comprising the multiplexed gene expression signatures that will eventually appear on the GeneXpert system.