Cepheid And Oregon Health & Science University Collaborate To Develop Oncology Assays For GeneXpert® System

SUNNYVALE, Calif., Feb. 19, 2013 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) and the Knight Cancer Institute at Oregon Health & Science University (OHSU) today 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, Ph.D., Associate Director of Translational Research for the Knight Cancer Institute at OHSU, and Michael Bates, M.D., Cepheid's Vice President, Oncology Research & Development.  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 tumor tissue.

"Cepheid is honored 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, M.D., Ph.D., 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, M.D., Ph.D. and M.B.A., 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 tumor'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 tumor behavior, 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.

About Cepheid
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests.  By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases.  Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.

About the Knight Cancer Institute at Oregon Health & Science University
The Knight Cancer Institute at Oregon Health & Science University is a pioneer in personalized cancer medicine. The institute's director, Brian Druker, M.D., helped prove it was possible to shut down cells that enable cancer to grow without harming healthy cells. This breakthrough has helped make once-fatal forms of the disease manageable and ushered in a new generation of targeted cancer therapies. The OHSU Knight Cancer Institute is the only National Cancer Institute-designated Cancer Center between Sacramento and Seattle—an honor earned only by the nation's top cancer centers. It offers the latest treatments and technologies as well as hundreds of research studies and clinical trials.

Forward-Looking Statements
This press release contains forward-looking statements that are not purely historical regarding Cepheid's or its management's intentions, beliefs, expectations and strategies for the future, including those relating to product performance, timing of future product releases, future collaborations, pricing for future product releases, availability of tests and demand for the Company's products.  Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the Company's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: our ability to develop new products and complete clinical trials successfully in a timely manner for new products, including unforeseen delays and costs; the ability to complete clinical trials successfully in a timely manner; uncertainties related to the regulatory processes; the performance and market acceptance of new products; sufficient customer demand and available capital budgets for our customers; uncertainties related to the FDA regulatory and European regulatory processes; the level of testing at clinical customer sites, including for Healthcare Associated Infections (HAIs); the Company's ability to successfully introduce and sell products in clinical markets other than HAIs; other unforeseen supply, development and manufacturing problems; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; lengthy sales cycles in certain markets; the impact of competitive products and pricing; and underlying market conditions worldwide.  Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K, its most recent Quarterly Report on Form 10-Q, and its other reports filed with the Securities and Exchange Commission.

All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.

SOURCE Cepheid